Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial.

BACKGROUND: Safe laparoscopic cholecystectomy may necessitate biliary imaging, and non-invasive fluorescence cholangiography may have advantages over contrast X-ray cholangiography. This trial compared fluorescence and X-ray cholangiography for visualization of the critical junction between the cystic, common hepatic and common bile ducts. METHODS: This non-inferiority blinded RCT included patients who had either intraoperative fluorescence cholangiography using 0·05 mg/kg indocyanine green or X-ray cholangiography during elective laparoscopic cholecystectomy. RESULTS: Between March 2015 and August 2018, a total of 120 patients were randomized (60 in each group). There were no drop-outs and 30-day follow-up data were available for all patients. In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230). Fluorescence cholangiography was faster by a few minutes: median 2·0 (range 0·5-5·0) versus 4·8 (1·3-17·6) min (P < 0·001). CONCLUSION: Fluorescence cholangiography was confirmed to be non-inferior to X-ray cholangiography in visualizing the critical junction during laparoscopic cholecystectomy. Registration number: NCT02344654 ( http://www.clinicaltrials.gov).

ANTECEDENTES: La práctica de una colecistectomía laparoscópica segura puede requerir imágenes de la vía biliar, en las cuales la colangiografía con fluorescencia no invasiva puede tener ventajas sobre la colangiografía con contraste con rayos X. Este ensayo comparó la colangiografía con fluorescencia con la colangiografía con rayos X para la visualización de la unión crítica entre el conducto cístico, el conducto hepático común y los conductos biliares comunes. MÉTODOS: Ensayo clínico aleatorizado, ciego, de no inferioridad que incluyó a 120 pacientes en los que durante la colecistectomía laparoscópica electiva se practicó una colangiografía con fluorescencia intraoperatoria utilizando 0,05 mg/kg de verde de indocianina o una colangiografía con rayos X. RESULTADOS: De marzo de 2015 a agosto de 2018, se aleatorizaron un total de 120 pacientes (6 en cada grupo), en los que no hubo abandonos y con datos de seguimiento de 30 días disponibles en todos ellos. Basado en un análisis por intención de tratamiento, la capacidad de visualizar la unión crítica fue igual entre los dos grupos (49/60 versus 51/60, P = 0,23). La colangiografía con fluorescencia fue más rápida de realizar, en unos pocos minutos (mediana 2 min (rango 0,5-5,0) versus 5 min (rango 5,2-17,6), P < 0,001). CONCLUSIÓN: Se confirmó que la colangiografía con fluorescencia no fue inferior a la colangiografía con rayos X para visualizar la unión crítica durante la colecistectomía laparoscópica.

Effect of high-volume systematic local infiltration analgesia in Caesarean section: a randomised, placebo-controlled trial.

BACKGROUND: Pain after Caesarean section is often treated with opioids with a risk of side effects. Wound infiltration with local anaesthetics is effective and has few side effects, but volume vs. dose concentration has not been examined. METHODS: Ninety patients scheduled for elective Caesarean section included in a randomised, double-blinded, placebo-controlled trial receiving infiltration with 50 ml ropivacaine 0.5% or 125 ml ropivacaine 0.2% or 50 ml 0.9% saline (placebo) during surgery. Surgery was performed under lumbar spinal anaesthesia. Primary endpoint was post-operative pain. Secondary endpoints were rescue analgesic, post-operative nausea and vomiting, time spent in the postanesthesia care unit (PACU) and time to first mobilisation. RESULTS: No difference in pain response between groups, but time until maximum pain score was prolonged in the ropivacaine 0.5% group compared with the placebo group (P = 0.0493). The administration of ketobemidone at 24 h post-operatively in the ropivacaine 0.5% group was reduced compared with the placebo group (P = 0.020), and between the ropivacaine 0.2% group and the ropivacaine 0.5% group (P = 0.044). No significant differences between groups were found concerning time spent in the PACU, to first mobilisation or in number of women with nausea/vomiting (P ≥ 0.05). No complications related to ropivacaine were observed. CONCLUSIONS: Systematic infiltration with a high concentration, low volume compared with low concentration, high volume showed no significant effect on post-operative pain intensity. However, a statistically significant, but clinically limited opioid sparing effect was demonstrated compared with placebo in the high concentration, low volume group.

Effect of high-dose preoperative methylprednisolone on recovery after total hip arthroplasty: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: High-dose glucocorticoid may reduce postsurgical pain and improve recovery. We hypothesized that 125 mg methylprednisolone (MP) would reduce time to meet functional discharge criteria after total hip arthroplasty (THA). METHODS: Forty-eight patients undergoing unilateral THA under spinal anaesthesia were consecutively included in this randomized, double-blind, placebo-controlled trial receiving preoperative i.v. MP or saline. All patients received a standardized, multimodal analgesic regime with paracetamol, celecoxib, and gabapentin. The primary outcome was time to meet well-defined functional discharge criteria. Secondary outcomes were handgrip strength and endurance, pain, nausea, vomiting, fatigue, sleep quality, and rescue analgesic-, antiemetic-, and hypnotic medicine requirements. The inflammatory response measured by C-reactive protein (CRP) and actual length of stay were also registered. Discharge criteria were assessed twice daily (at 09:00 and 14:00 h) until discharge. Other outcomes were assessed at 2, 4, 6, 8, and 24 h after operation, and also in a questionnaire from postoperative day (POD) 1-4. RESULTS: Time to meet discharge criteria was [median (IQR) (95% CI), MP vs placebo]: 23.5 (23.3-23.7) (17.8-43.8) vs 23.5 (23.0-23.8) (20.0-46.8) h, the mean difference (95% CI) being -1.3 (-4.7 to 2.2) h, P=0.65. Overall pain for the first 24 h after surgery was significantly reduced in the MP vs the placebo group (P<0.01), as was CRP at 24 h (P<0.0001). No other between-group differences were observed. No drug-related complications were observed at follow-up on POD30. CONCLUSIONS: MP 125 mg i.v. before surgery added to a multimodal oral analgesic regime did not reduce time to meet functional discharge criteria after THA, but improved analgesia for the first 24 h.

Possible effects of mobilisation on acute post-operative pain and nociceptive function after total knee arthroplasty.

BACKGROUND: Experimental studies in animals, healthy volunteers, and patients with chronic pain suggest exercise to provide analgesia in several types of pain conditions and after various nociceptive stimuli. To our knowledge, there is no data on the effects of exercise on pain and nociceptive function in surgical patients despite early mobilisation being an important factor to enhance recovery. We therefore investigated possible effects of mobilisation on post-operative pain and nociceptive function after total knee arthroplasty (TKA). METHODS: Thirty patients undergoing TKA under standardised anaesthesia and analgesia underwent an exercise (mobilisation) strategy on the first post-operative morning consisting of 25-m walking twice, with a 20-min interval. Pain was assessed at rest and during passive hip and knee flexion before, and 5 and 20 min after walk, as well as during walk. Nociceptive function (pain threshold and tolerance) was assessed with pressure algometry and an electrical stimulus. RESULTS: Pain at rest (supine) and during hip and knee flexion was significantly reduced 5 min (P < 0.03) and 20 min (P < 0.003) after walk compared with before walk, and pain was reduced during the second walk compared with the first walk (P < 0.034). Knee pain pressure threshold (P = 0.002) but not tolerance (P = 0.27) was increased following walk compared with before walk. CONCLUSION: This first exploratory hypothesis-generating pilot study suggests mobilisation to promote analgesic effects after TKA calling for future studies with a randomised, controlled design on exercise dose-response effects in post-surgical patients.

Post-anaesthesia care unit stay after total hip and knee arthroplasty under spinal anaesthesia.

BACKGROUND: Post-anaesthesia care unit (PACU) admission must be well founded and the stay as short as possible without compromising patient safety. However, within the concept of fast-track surgery, studies are limited in addressing the question: why are patients staying in the PACU? METHODS: All patients operated with primary unilateral total hip or knee arthroplasty (THA or TKA) under spinal anaesthesia were included in this hypothesis-generating, prospective, observational cohort study during a 4-month period. Surgical technique, analgesia, and perioperative care were standardized. Well-defined PACU discharge criteria that had to be met on two successive assessments were evaluated every 15 min until discharge. The primary outcome was time to meet PACU discharge criteria. Secondary outcomes were actual discharge time from the PACU, specific factors detaining patients in the PACU, and potential complications at the surgical ward at follow-up 24 h post-operatively. RESULTS: One hundred sixty-three patients were included in the final analysis (69 THA and 94 TKA). Time to meet PACU discharge criteria was [median (interquartile range)(95% confidence interval)]: 15 min (15-15)(15-116) for THA and 15 min (15-15)(15-75) for TKA. Actual discharge time from PACU was: 25 min (20-35)(16-198) for THA and 25 min (20-31)(15-107) for TKA. Reasons for not meeting PACU discharge criteria in 15 min were mainly low oxygen saturation and pain. The short stay in the PACU did not impose complications at the surgical ward. CONCLUSION: The vast majority of patients (> 85%) operated with THA and TKA under low-dose spinal anaesthesia may achieve pre-defined PACU discharge criteria in 15 min. Large-scale studies should be performed to evaluate safety aspects after short PACU stay.

Fast-track surgery for bilateral total knee replacement.

Bilateral simultaneous total knee replacement (TKR) has been considered by some to be associated with increased morbidity and mortality. Our study analysed the outcome of 150 consecutive, but selected, bilateral simultaneous TKRs and compared them with that of 271 unilateral TKRs in a standardised fast-track setting. The procedures were performed between 2003 and 2009. Apart from staying longer in hospital (mean 4.7 days (2 to 16) versus 3.3 days (1 to 25)) and requiring more blood transfusions, the outcome at three months and two years was similar or better in the bilateral simultaneous TKR group in regard to morbidity, mortality, satisfaction, the range of movement, pain, the use of a walking aid and the ability to return to work and to perform activities of daily living. Bilateral simultaneous TKR can therefore be performed as a fast-track procedure with excellent results.

Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial.

BACKGROUND: Total knee arthroplasty (TKA) is associated with severe pain and inflammation despite an extensive multimodal analgesic approach, but the effect of high-dose glucocorticoid administration has not been studied. METHODS: Forty-eight patients undergoing unilateral TKA were included in a randomized, double-blind, placebo-controlled trial receiving preoperative methylprednisolone (MP) 125 mg i.v. or saline. All surgery was performed under lumbar spinal anaesthesia and patients received a standardized, multimodal analgesic regime. The primary endpoint was pain during walking 24 h after surgery, and secondary endpoints were pain at rest, pain upon hip flexion, and pain upon knee flexion. Pain assessments were performed repeatedly for the first 48 h after surgery, in a questionnaire from days 2 to 10, and at follow-up on days 21 and 30. Tertiary endpoints were postoperative nausea and vomiting (PONV), plasma C-reactive protein (CRP) concentrations, fatigue, sleep quality, and rescue analgesic and antiemetic requirements. RESULTS: Pain during walking was significantly lower in the MP group up to 32 h after operation. Overall pain and cumulative pain scores (2-48 h) were lower for all pain assessments (P<0.04). Consumption of rescue oxycodone was lower from 0 to 24 h (P=0.02) and PONV, consumption of ondansetron reduced (P<0.05), and CRP concentrations were lower at 24 h (P<0.000001). Fatigue throughout the day of surgery was lower (P=0.02), but sleep quality was worse on the first night (P=0.002). No side-effects or complications were observed in other respects. CONCLUSIONS: MP 125 mg before surgery improves analgesia and immediate recovery after TKA, even when combined with a multimodal analgesic regime. These findings call for further studies on safety aspects.

Analgesic efficacy of local anaesthetic wound administration in knee arthroplasty: volume vs concentration.

Wound administration of local anaesthetic may be effective for postoperative pain management in knee arthroplasty, but the analgesic efficacy of local anaesthetic in relation to volume vs concentration has not been determined. In a double-blinded trial, 48 patients scheduled for total knee arthroplasty were randomly assigned to receive either a high volume/low concentration solution of ropivacaine (20 ml, 0.5%) or a low volume/high concentration solution of ropivacaine (10 ml, 1%), 6 and 24 h postoperatively through an intracapsular catheter. Pain was assessed for 2 h after administration. Pain was reduced in both groups with ropivacaine administration 24 h postoperatively (p < 0.02), but with no difference in analgesia between groups at all time intervals. No reduction in pain scores was observed with ropivacaine injection 6 h postoperatively. The median (IQR [range]) dose of oxycodone administered was 12.5 (10-19 [0-35]) mg in the high volume/low concentration group, and 20 mg (16-40 [0-65]) mg in the low volume/high concentration group (p = 0.005). In conclusion, intracapsular administration of local anaesthetic may have limited analgesic efficacy with no volume vs concentration relationship after total knee arthroplasty.

Analgesic efficacy of intracapsular and intra-articular local anaesthesia for knee arthroplasty.

The optimal site for wound delivery of local anaesthetic after total knee arthroplasty is undetermined. Sixty patients having total knee arthroplasty received intra-operative infiltration analgesia with ropivacaine 0.2% and were then were randomly assigned to receive either intracapsular or intra-articular catheters with 20 ml ropivacaine 0.5% given at 6 h and again at 24 h, postoperatively. Analgesic efficacy was assessed for 3 h after each injection, using a visual analogue score, where 0 = no pain and 100 = worst pain. There was no statistically significant difference between groups. Maximum pain relief (median (IQR [range])) at rest observed in the 3 h after the 6 and 24 h postoperative injections was 17 (7-31 [0-80]) and 10 (4-27 [0-50]) p = 0.27 for 6-9 h; and 17 (7-33 [0-100]) and 13 (3-25 [0-72]) p = 0.28 for 24-27 h, for intracapsular and intra-articular, respectively. Intracapsular local anaesthetic has similar analgesic efficacy to intra-articular after total knee arthroplasty.

Analgesic efficacy of subcutaneous local anaesthetic wound infiltration in bilateral knee arthroplasty: a randomised, placebo-controlled, double-blind trial.

BACKGROUND: High-volume wound local infiltration analgesia is effective in knee arthroplasty, but the analgesic efficacy of subcutaneous wound infiltration has not been evaluated. METHODS: In a randomised, double-blind, placebo-controlled trial in 16 patients undergoing bilateral knee arthroplasty with high-volume local infiltration analgesia in the deeper layers, saline or ropivacaine 2 mg/ml was infiltrated into the subcutaneous part of the wound in each knee along with the placement of multi-fenestrated catheters in the subcutaneous wound layers in both knees. Pain was assessed for 6 h post-operatively and for 3 h after a bolus injection given through the catheter 24 h post-operatively. RESULTS: Visual analogue scale (VAS) pain scores were significantly lower from the knee infiltrated with ropivacaine compared with the knee infiltrated with saline in the subcutaneous layer of the wound, at rest (P<0.02), with flexion of the knee (P<0.04) and when the leg was straight and elevated (P<0.04). Twenty-four hours post-operatively, a decline in the VAS pain scores was observed in both groups, with no statistically significant difference between injection of ropivacaine or saline in the subcutaneously placed catheters (P>0.05). CONCLUSION: As part of a total wound infiltration analgesia intraoperative subcutaneous infiltration with ropivacaine in bilateral total knee arthroplasty is effective in early post-operative pain management, while a post-operative subcutaneous bolus administration through a multiholed catheter 24 h post-operatively did not show improved analgesia compared with the administration of saline.

Subacute pain and function after fast-track hip and knee arthroplasty.

In a well-defined fast-track setup for total hip and knee arthroplasty, with a multimodal analgesic regimen consisting of intra-operative local anaesthetic infiltration and oral celecoxib, gabapentin and paracetamol for 6 days postoperatively, we conducted a prospective, consecutive, observational study. The purpose was to describe the prevalence and intensity of subacute postoperative pain and opioid related side effects, use of analgesics and functional ability 1-10 and 30 days postoperatively. Fast-track total hip and knee arthroplasty with early discharge (< 3 days) resulted in acceptable levels of pain and postoperative nausea and vomiting with concomitant low use of opioids in > 95% of patients after discharge before day 10 after total hip arthroplasty. However, after total knee arthroplasty 52% patients reported moderate pain (VAS 30-59 mm), and 16% severe pain (VAS > or = 60 mm) when walking 1 month after surgery with a concomitant increase in the use of strong opioids. These results emphasise the need for improvement in analgesia after discharge following total knee arthroplasty, to facilitate rehabilitation.

High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: High-volume infiltration analgesia may be effective with a low risk of side effects in hip and knee arthroplasty. The present placebo-controlled study was carried out to evaluate the analgesic effect of high-volume infiltration analgesia in bilateral total knee arthroplasty, along with a detailed description of the infiltration technique. METHODS: In a randomized, double-blind, placebo-controlled trial in 12 patients undergoing bilateral knee arthroplasty, saline or high-volume (170 ml) ropivacaine (0.2%) with epinephrine was infiltrated around each knee, with repeated doses administered through an intra-articular catheter for 24 h and pain and opioid requirements assessed for 48 h in a fast-track setting. RESULTS: Pain at rest and during movement was significantly reduced for up to 32 h with the high-volume local anesthetic infiltration technique. No major side effects were observed. The median hospital stay was 4 days. CONCLUSION: High-volume infiltration analgesia is effective in knee arthroplasty and, due to its simplicity, may be preferable compared with other analgesic techniques in knee arthroplasty.

Acute cognitive dysfunction after hip fracture: frequency and risk factors in an optimized, multimodal, rehabilitation program.

BACKGROUND: Patients undergoing hip fracture surgery often experience acute post-operative cognitive dysfunction (APOCD). The pathogenesis of APOCD is probably multifactorial, and no single intervention has been successful in its prevention. No studies have investigated the incidence of APOCD after hip fracture surgery in an optimized, multimodal, peri-operative rehabilitation regimen. METHODS: One hundred unselected hip fracture patients treated in a well-defined, optimized, multimodal, peri-operative rehabilitation regimen were included. Patients were tested upon admission and on the second, fourth and seventh post-operative days with the Mini Mental State Examination (MMSE) score. RESULTS: Thirty-two per cent of patients developed a significant post-operative cognitive decline, which was associated with several pre-fracture patient characteristics, including age and cognitive function, but also the number of peri-operative transfusions. The development of APOCD was also associated with impaired post-operative rehabilitation and an increased length of stay. APOCD was associated with the development of a major medical complication in 35% of all patients. In 65% of patients developing APOCD without a concomitant medical complication, the only risk factors were cognitive level and regular anti-psychotic treatment. CONCLUSION: On the basis of current evidence, APOCD is prevalent amongst hip fracture patients despite multimodal intervention; future research should therefore focus on defining subgroups of hip fracture patients amenable to specific prophylactic or interventional measures against APOCD.

Post-operative rounds by anaesthesiologists after hip fracture surgery: a pilot study.

BACKGROUND: Efforts to optimize the peri-operative care of hip fracture patients through multidisciplinary intervention have focused on orthopaedic-geriatric liaisons, which have not resulted in significant outcome changes. The early phase of rehabilitation could potentially be optimized through a multidisciplinary effort between anaesthesiologists and orthopaedic surgeons. METHODS: During the first 25 weeks of 2004, 98 consecutive community-residing patients admitted to a hip fracture unit received daily rounds by anaesthesiologists during the first four post-operative days, on weekdays only, focusing on all facets of peri-operative care. Two hours were allotted to rounds in the 14-bed unit. One hundred and twenty-six consecutive patients admitted to the unit in 2003, receiving the same well-defined care programme, were chosen as a control group. Outcome measures were morbidity and the need for visits by external specialists. RESULTS: The intervention group received 291 rounds by anaesthesiologists. Active therapeutic interventions were prescribed in 76% of all patient confrontations. The control group received 128 requested visits from internal medicine specialists, which was reduced to 50 in the intervention group (P = 0.02). There was no significant difference between post-operative morbidity and hospital stay in the control and intervention groups; in-hospital mortality was 12% in the control group and 7% in the intervention group (P = 0.24). The rounds by anaesthesiologists improved nursing care conditions. CONCLUSION: This pilot study, with insufficient power to show significant differences in outcome, supports further evaluation of the concept of intensified orthopaedic-anaesthesiological co-operation after hip fracture surgery. Such a randomized trial should evaluate economic and clinical outcome aspects, providing anaesthesiological rounds 7 days per week.

Postural stability after inguinal herniorrhaphy under local infiltration anaesthesia.

OBJECTIVE: To investigate postural stability in patients after inguinal herniorrhaphy under local infiltration anaesthesia, to see if the anaesthetics and analgesics used influenced it and therefore hindered early discharge. DESIGN: Open study. SETTING: Teaching hospital, Denmark. SUBJECTS: 55 patients listed for elective inguinal herniorrhaphy. INTERVENTIONS: Preoperative and intraoperative infiltration anaesthesia by bupivacaine 2.5 mg/ml (median dose 41 ml, range 30-84 ml), and sedation with midazolam intraoperatively (median dose 3 mg, range 0-10 mg). Lichtenstein tension-free technique with polypropylene mesh repair (Prolene). Measurement of postural stability before operation and 30 and 60 minutes afterwards using the "Basic Balance Master" system, and balance assessed by visual analogue scale and verbal rating scale. MAIN OUTCOME MEASURES: Postural stability and subjectively assessed balance. RESULTS: Dynamic postural stability was impaired 30 min (p < 0.05), but not 60 minutes postoperatively. All but two patients were discharged shortly after the measurement at 60 minutes, because of pain in one and an attack of asthma in the other. Balance also returned to normal within an hour. CONCLUSION: Objectively measured postural stability and subjectively assessed balance return to normal within 60 minutes after inguinal herniorrhaphy under local infiltration anaesthesia, thereby permitting early discharge.

Lack of postoperative pain relief after hysterectomy using preperitoneally administered bupivacaine.

BACKGROUND AND OBJECTIVES: It is well known that wound infiltration with local anesthetic can reduce postoperative pain in various degrees and with very few side effects. A previous study showed better analgesic effect when local anesthetic was applied in the subfascial, rather than the subcutaneous, layer. The present study investigated the effect of frequent bolus injections of bupivacaine (15 mL 2.5 mg/mL) preperitoneally through catheters placed intraoperatively in women who had undergone hysterectomy. METHODS: Postoperative pain and analgesic requirements were studied in a double-blind randomized trial including 41 patients. During surgery, the patients were randomized to one of two groups, and the investigators were blinded. Prior to closure of the peritoneum, the surgeon placed a catheter between the muscle layer and the peritoneum on each side of the wound. One group (n = 22) received bupivacaine (15 mL 2.5 mg/mL) every 4 hours for 48 hours via each catheter starting in the operating room. The placebo group (n = 19) received saline in a like manner. Postoperative pain was evaluated using a visual analog scale (VAS) and verbal rating scale (VRS) twice a day for 2 days at rest and on movement. Requirements of supplementary analgesics were monitored, as was wound infection after discharge. RESULTS: Bupivacaine administered preperitoneally did not improve analgesia at rest, during coughing, or during mobilization compared with saline. No difference between the groups was found regarding analgesic requirements. No complications of postoperative wound healing or toxic side effects were seen. CONCLUSION: Bolus injections of bupivacaine through intraoperative placed catheters did not improve analgesia postoperatively compared with saline injections.

[Reduced sense of taste as a complication of the laryngeal mask use]. / Nedsat smagssans som komplikation til anvendelse af larynxmaske.

We report a unilateral lingual nerve paralysis following the use of a laryngeal mask airway in a 73-year-old man with hypertrophy of the prostate undergoing a TUR-P. The operation was performed in general anaesthesia using propofol, fentanyl, alfentanil and ventilation with 100% oxygen. The operation was uncomplicated and had a duration of two hours and twenty minutes. A week later the patient perceived a reduced sense of taste. Six months later the situation was unaltered.

[Nitric oxide treatment of children with impairment of oxygenation]. / Nitrogenoxydbehandling af børn med oxygeneringsproblemer.

It is well-known that inhaled nitric oxide improves the perfusion of ventilated regions, thus reducing intrapulmonary shunting and improving arterial oxygenation. However, most cases describe treatment of neonates and adults, only few studies describe effects of inhaled nitric oxide in children with severe impairment of oxygenation. Four cases of severe hypoxaemic respiratory failure in children treated successfully with inhaled nitric oxide are described.