Patient satisfaction with intravenous regional anaesthesia or an axillary block for minor ambulatory hand surgery: A randomised controlled study.

BACKGROUND: Intravenous regional anesthesia (IVRA) and the axillary brachial plexus block are popular alternatives to general anaesthesia in ambulatory hand surgery. Although both have proven their effectiveness, patients' preferences have never been evaluated. OBJECTIVES: We investigated patient satisfaction with both techniques and hypothesised that satisfaction after IVRA is noninferior compared with axillary brachial plexus block. DESIGN: A prospective, randomised controlled trial. SETTING: Ambulatory surgical day care centre, University Hospitals of Leuven, Belgium, from September 2016 to November 2017. PATIENTS: One hundred and twenty adults undergoing minor ambulatory hand surgery were included in this study. INTERVENTION: Patients received either IVRA with 300 mg lidocaine or an axillary block with 280 mg mepivacaine. MAIN OUTCOME MEASURES: The primary endpoint was the evaluation of patient satisfaction using the 'Evaluation du Vécu de l'Anésthesie Locoregional' (EVAN-LR) questionnaire. Secondary outcomes included different procedural times, block quality, tourniquet discomfort, the incidence of block failure and postoperative nausea and vomiting (PONV), the severity of postoperative pain and the need for postoperative analgesics during the first 24 h. RESULTS: Noninferiority of IVRA was shown for the median [IQR] total score on the EVAN-LR questionnaire, IVRA-group: 92 [87 to 96] vs. axillary brachial plexus block-group: 91[87 to 97]; Hodges--Lehmann estimator (95% confidence interval (CI)] for the shift: -0.25 (-2.60 to 2.20). Induction of anaesthesia and time to discharge, requiring partial recovery of the motor block, were significantly longer in the axillary brachial plexus block group. The IVRA-group had a lower block quality, a higher incidence of tourniquet-discomfort and higher median intra-operative and postoperative pain scores on day 0; 0 [0 to 2] vs. 0 [0 to 0] and 0.8 [0 to 1.8] vs. 0 [0 to 0.25], respectively, but no increase in the need for supplementary analgesics or conversion rate to general anaesthesia. CONCLUSION: IVRA and axillary brachial plexus block result in comparably high patient satisfaction in ambulatory hand surgery. CLINICAL TRIAL REGISTRATION: EudraCT 2016-002325-11.

Evone® Flow-Controlled Ventilation During Upper Airway Surgery: A Clinical Feasibility Study and Safety Assessment.

Introduction: During upper airway surgery in a narrowed airway due to tumor or stenosis, safe ventilation, good laryngotracheal exposure, and preservation of an adequate surgical working space are of paramount importance. This can be achieved by small-lumen ventilation such as High Frequency Jet Ventilation (HFJV). However, this technique has major drawbacks, such as air-trapping and desaturation in patients with poor pulmonary reserve. Recently, an innovative ventilating system with flow-controlled ventilation (FCV) and a small-lumen endotracheal tube, the Evone® (Ventinova, Eindhoven, The Netherlands), was introduced, claiming to counter the drawbacks of HFJV. Objectives: To evaluate feasibility and safety of the Evone® FCV system in difficult upper airway surgery and to critically appraise this novel ventilation method. Patients and methods: Evone® is a FCV-device using a small-bore cuffed tube (Tritube®). This ventilator actively sucks air out of the lungs, rather than relying on the passive backflow of air like in HFJV. Data related to the medical history, surgery, and anesthesia of all consecutive patients undergoing upper airway surgery with Evone® FCV ventilation were included in a tertiary center retrospective observational study. Results: Fifteen Patients, with a median age of 54 years, were included. Surgical procedures and indications included laser-assisted endoscopic treatment of idiopathic subglottic stenosis (n = 3), tracheal stenosis (n = 1), and posterior glottic stenosis (n = 2), biopsy and/or Transoral Laser Microsurgery for laryngeal (pre)malignancy (n = 7) and resection of benign lesions with posterior (supra)glottic location (n = 2). Mean ventilation duration was 52.0 min (range 30-115 min, SD 19.6 min), mean surgery duration was 31.7 min (range 15-65 min, SD 13.2 min), mean minimal SaO2 was 96.3% (range 89-100%, SD 4.0%) and mean peak pCO2 was 41.4 mmHg (range 31-50 mmHg, SD = 5.5 mmHg). No anesthesia- or surgery-related complications, adverse events or intra-operative difficulties were reported during or after any of the 15 procedures. In all cases, compared to HFJV, Evone® FCV ventilation allowed a superior visualization and working space during the surgical procedure. Conclusion: The Evone® FCV ventilation system provides excellent conditions in patients undergoing upper airway surgery, as it combines excellent accessibility and visibility of the operation site with safe and stable ventilation.

Bupivacaine infiltration in children for postoperative analgesia after tonsillectomy: A randomised controlled trial.

BACKGROUND: Adenotonsillectomy is a frequently performed procedure in paediatric day-case surgery. Postoperative pain can be significant and standard analgesia protocols are often insufficient. OBJECTIVE: Our primary objective was to investigate if infiltration of the peritonsillar space with bupivacaine would reduce the need for postoperative opioids compared with pre-emptive intravenous tramadol. DESIGN: A double-blind, randomised controlled trial. SETTING: Ambulatory surgical day care centre, University Hospitals of Leuven, Belgium, from January 2012 to September 2016. PATIENTS: Two hundred children, between 4 and 10 years old, undergoing elective adenotonsillectomy were included in the study. INTERVENTION: Children were randomly allocated to receive either a bolus of 3 mg kg intravenous tramadol or infiltration of the tonsillar lodge with 5-ml bupivacaine 0.25%. Reasons for exclusion were American Society of Anesthesiologists classification greater than 2, allergies to the investigated products, psychomotor retardation, bleeding disorders and lack of proficiency in Flemish. MAIN OUTCOME MEASURES: The primary endpoint was the number of children in need of piritramide postoperatively. Secondary outcomes included the cumulative dose of postoperative piritramide, pain scores and the incidence of postoperative nausea and vomiting during the first 24 postoperative hours, time to discharge and adverse effects. RESULTS: The proportion of children in need of postoperative piritramide was significantly lower in the tramadol group than in children with peritonsillar infiltration (57 vs. 81%, P < 0.001). When in need of postoperative piritramide, the tramadol-group required a significantly lower dose (median [IQR] 0.7 [0.6 to 1] vs. 1 [0.6 to 1.5] mg, P < 0.007) and had lower pain scores during the first 60 min after surgery. There were no statistically significant differences in postoperative nausea and vomiting incidence, need for antiemetics or complications. CONCLUSION: Compared with peritonsillar infiltration, preemptive intravenous tramadol decreases the need for postoperative opioids after tonsillectomy in children without increasing the incidence of side effects. TRIAL REGISTRATION: EudraCT 2011-005467-25.

Dorsal penile nerve block for circumcision in pediatric patients: A prospective, observer-blinded, randomized controlled clinical trial for the comparison of ultrasound-guided vs landmark technique.

BACKGROUND AND AIMS: Circumcision is a frequently performed procedure in day case pediatric surgery. Dorsal penile nerve block has proven its effectiveness for the management of acute postoperative pain after circumcision. We investigated if the ultrasound-guided placement of a dorsal penile nerve block could reduce opioid requirement as compared to a landmark-based technique. METHODS: Three hundred and ten prepubertal children, aged between 52 weeks postconception and 11 years, were included in this prospective, observer-blinded, randomized controlled trial and received either a landmark- or an ultrasound-guided dorsal penile nerve block, using a caudal needle and injecting 0.1 mL/kg levobupivacaine 0.5% bilaterally. A single, experienced investigator performed all blocks. The primary endpoint was the number of patients in need of piritramide postoperatively as triggered by the Objective Pain Scale. Secondary outcome parameters included the cumulative dose of postoperatively administered opioids, the requirement to administer fentanyl intraoperatively, the need for paracetamol and ibuprofen during the first 24 postoperative hours, postoperative pain scores, the incidence of postoperative nausea and vomiting, the anesthesia induction time, and the time to discharge. RESULTS: The proportion of patients requiring postoperative piritramide did not differ significantly between both groups (Landmark: 38% vs Ultrasound: 47%, with a difference in proportion between both conditions (95% CI): 0.09 (0.2 to 0.02); P = .135). In addition, the cumulative doses of postoperative piritramide and intraoperative fentanyl, the postoperative need for paracetamol or ibuprofen, pain scores, the incidence of postoperative nausea and vomiting, and the time to discharge were not different either. However, the anesthesia induction time was significantly longer in the ultrasound-guided dorsal penile nerve block (median time [IQR]: Landmark: 11[9; 13] min vs Ultrasound: 13[11; 15] min, P < .001). CONCLUSION: Compared with the landmark-guided, the ultrasound-guided dorsal penile nerve block did not reduce the need for postoperative analgesia after circumcision in children, but was associated with an increase in the procedural time.

Measuring satisfaction and anesthesia related outcomes in a surgical day care centre: A three-year single-centre observational study.

STUDY OBJECTIVE: To evaluate patient satisfaction and patient reported anaesthesia related outcome parameters after outpatient surgery. DESIGN: A three-year (2013-2016) observational study. SETTING: A surgical day care centre embedded in a tertiary care, university hospital. PATIENTS: Adult Dutch-speaking patients who underwent surgery under general or regional anaesthesia on an outpatient basis (n=5424). INTERVENTIONS: A questionnaire was developed to evaluate patients' satisfaction with care during their hospitalisation in the surgical day centre, as well as to assess their reports of anaesthesia related outcomes. MEASUREMENTS: Various aspects of care were measured, including care by nurses, care by doctors, organisational and safety items. Variation in satisfaction and surgery and anaesthesia related outcomes as a function of different categories (gender, age, education, type of anaesthesia, discipline and era) were also investigated. MAIN RESULTS: Confirmatory factor analysis showed an excellent fit to the hypothesized factors of the survey. Satisfaction scores were very high for different aspects of care, resulting in 98% of patients being (very) satisfied (59.1% very satisfied, 38.9% satisfied). Male (p=0.0003), higher educated (p<0.0001) and older patients (p<0.0001) were more likely to be very satisfied. Postoperative nausea and vomiting (PONV) were frequent (nausea: 13.9%, vomiting: 3.3%), and more present in female than in male patients (p<0.0001). Pain scores at the PACU differed among disciplines (p<0.0001) were higher in female patients compared to male patients (3.41% versus 2.54%, p<0.0001) and after general anaesthesia compared to regional anaesthesia (3.25% versus 0.39%, p<0.0001) and decreased with higher age (p=0.0001) and education level (p=0.0033). CONCLUSIONS: Whereas satisfaction with all aspects of care is generally high, the results regarding pain and PONV should inspire quality improvement initiatives. The questionnaire developed in this study can be a vehicle to assess and improve the quality of care in surgical day care centres.

Comparison of 2-Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Knee arthroscopy is a well-established procedure in day-case surgery, which is frequently performed under spinal anesthesia. It is, however, controversial whether the choice for a specific local anesthetic translates into relevant outcomes. We hypothesized that the use of 2-chloroprocaine would be associated with a faster recovery from sensorimotor block. METHODS: Ninety-nine patients were included in this prospective, double-blind, randomized controlled trial and randomly allocated to receive either 40 mg 2-chloroprocaine, 40 mg lidocaine, or 7.5 mg bupivacaine. The primary endpoint was the time until complete recovery of sensory block. Secondary endpoints included time to recovery from motor block, failure rates, incidence of hypotension/bradycardia, postoperative pain, first mobilization, voiding and discharge times, and the incidence of transient neurologic symptoms. This clinical trial was registered prior to patient enrollment (EudraCT 2011-003675-11). RESULTS: Patients in the chloroprocaine group had a significantly shorter time until recovery from sensory block (median, 2.6 hours; interquartile range [IQR], 2.2-2.9 hours) than patients in the lidocaine group (3.1 hours; IQR, 2.7-3.6 hours; P < 0.006) and in the bupivacaine group (6.1 hours; IQR, 5.5 hours to undefined hours; P < 0.0001). Chloroprocaine was associated with a significantly faster recovery from motor block than lidocaine and bupivacaine. Times to first mobilization, voiding, and discharge were significantly shorter for chloroprocaine when compared with bupivacaine, but not with lidocaine. In the bupivacaine group, patients needed significantly less rescue medication for postoperative pain when compared with lidocaine and chloroprocaine. Groups did not differ with respect to patient satisfaction, incidence of bradycardia/hypotension, and transient neurologic symptom rate. CONCLUSIONS: For spinal anesthesia in patients undergoing ambulatory knee arthroscopy, chloroprocaine has the shortest time to complete recovery of sensory and motor block compared with bupivacaine and lidocaine.

Systemic Lidocaine Fails to Improve Postoperative Pain, But Reduces Time to Discharge Readiness in Patients Undergoing Laparoscopic Sterilization in Day-Case Surgery: A Double-Blind, Randomized, Placebo-Controlled Trial.

BACKGROUND AND OBJECTIVES: Perioperative systemic lidocaine provides postoperative analgesia, decreases opioid consumption, and facilitates rehabilitation in abdominal surgery. We hypothesized that systemic lidocaine has analgesic effects in women undergoing day-case laparoscopic sterilization. METHODS: Eighty women were randomized in this prospective, double-blind trial to receive either lidocaine (intravenous bolus of 1.5 mg/kg at induction of anesthesia, followed by an infusion of 1.5 mg · kg · h, which was continued until 30 minutes after arrival at the postanesthesia care unit [PACU]) or placebo. The primary end point was the proportion of patients with a numeric rating scale (NRS) of greater than 3, 30 minutes after arrival at the PACU. Secondary outcomes included total opioid consumption, postoperative pain scores, incidence of postoperative nausea and vomiting, and time to readiness for discharge. This clinical trial was registered (Eudra CT 2011-001315-31). RESULTS: Thirty minutes after PACU admission, the proportion of patients with an NRS score of greater than 3 did not differ between the groups (lidocaine group: 59% vs placebo group: 58%). The postoperative NRS for pain over the entire observation period was not significantly different between lidocaine and placebo groups (mean, 3.1 [SD, 0.7] vs 2.8 [SD, 0.6]; P = 0.4). Groups did not differ with respect to perioperative opioid consumption. Patients in the placebo group suffered significantly less from nausea (NRS: 0.1 [SD, 0.1] [placebo] vs 0.3 [SD, 0.1] [lidocaine]; P = 0.02) and required less postoperative nausea and vomiting rescue medication (1 patient in the placebo group vs 7 in the lidocaine group; P = 0.03). The time to meet hospital discharge criteria was significantly lower in the lidocaine group (median, 177 minutes [range, 96-408 minutes] vs 221 minutes [range, 121-420 minutes]; P = 0.02). The mean lidocaine plasma levels at the end of IV lidocaine infusion was 2.5 (SD, 1.1) µg/mL. CONCLUSIONS: In laparoscopic sterilization, systemic lidocaine reduces time to readiness for hospital discharge.

Alizapride and ondansetron for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic gynaecological surgery: A double-blind, randomised, placebo-controlled noninferiority study.

BACKGROUND: Postoperative nausea and vomiting (PONV) can be prevented. Alizapride is an established antiemetic that may be effective in this role. OBJECTIVE: Our primary objective was to test the hypothesis that alizapride is noninferior to ondansetron for the prophylaxis of PONV. DESIGN: A randomised, placebo-controlled, double-blinded noninferiority study. SETTING: University hospitals of Leuven, Belgium, from November 2008 to July 2011. PATIENTS: A total of 523 patients undergoing laparoscopic gynaecological surgery were included in the study. Reasons for exclusion were American Society of Anesthesiologists (ASA) greater than 2, hypersensitivity to the study medication, pregnancy, mental disorders, psychiatric illness or consumption of antiemetic drugs within 24 h before initiation of the study. INTERVENTION: Patients received either alizapride 100 mg, ondansetron 4 mg or placebo intravenously 30 min before the end of surgery. MAIN OUTCOME MEASURES: The main outcome measures included the incidences of postoperative nausea (PON) and postoperative vomiting (POV) during the stay in the postanaesthetic care unit (PACU), with noninferiority testing for alizapride versus ondansetron. The region of noninferiority was defined as a relative difference in incidence of 25%. Secondary outcome was the incidence of PONV in the PACU and after 24 h. RESULTS: In the alizapride group, 32% of the patients experienced PON during the PACU stay, compared with 28% in the ondansetron group [relative risk 1.13, 90% confidence interval (CI) 0.87 to 1.46], exceeding the predefined margin of noninferiority. With respect to the incidences of POV during the PACU stay, 12.8% of the patients randomised to receive alizapride experienced POV, compared with 7.7% of who received ondansetron (relative risk 1.67, 90% CI 1.00 to 2.87). The incidences of PON and POV in the placebo group during the PACU stay were 34.2 and 9.8%, respectively. The 24-h incidences of PONV were lower than expected in this high-risk group of patients and were similar at 39.3, 36.8 and 31.5% in the placebo, alizapride and ondansetron groups, respectively (χ², P = 0.36). Patients treated with ondansetron required significantly less rescue medication than placebo-treated patients (P = 0.035). Due to the lower than expected incidences of PONV in this study, the power to conclude any noninferiority of alizapride was reduced to only 41%. CONCLUSION: We found no evidence to support the noninferiority of alizapride 100 mg when compared with ondansetron 4 mg for the intraoperative prophylaxis of PONV. However, the lower than expected incidences of PONV reduced the power of this study to conclude noninferiority or confirm significant beneficial effects for either antiemetic for PON and POV during the PACU stay. TRIAL REGISTRATION: Eudra CT 2008-004789-20.