Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial.

BACKGROUND: More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group). METHODS: In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0-2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications. RESULTS: In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75-2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found. CONCLUSION: Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay. CLINICAL TRIAL REGISTRATION: EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).

Transversus abdominis plane block after laparoscopic colonic resection in cancer patients: A randomised clinical trial.

BACKGROUND: A key point in pathways for optimal rehabilitation and enhanced recovery is an effective postoperative multimodal pain treatment regimen. OBJECTIVE: To investigate the analgesic effects of transversus abdominis plane (TAP) block in conjunction with paracetamol and ibuprofen in patients undergoing laparoscopic colonic resection. DESIGN: Randomised placebo-controlled double-blind study. SETTING: Herlev University Hospital, Copenhagen, Denmark, from March 2010 to February 2013. PATIENTS: Eighty adult patients scheduled for elective laparoscopic colectomy. INTERVENTIONS: Bilateral TAP block with 20 ml of either ropivacaine or isotonic saline. MAIN OUTCOME MEASURES: Visual analogue scale (VAS) pain scores (0 to 100 mm) while coughing at 6 h after surgery (primary outcome). Secondary outcomes were area under the curve pain scores (2 to 24 h) at rest and while coughing, 24-h morphine consumption and incidence of nausea and vomiting. RESULTS: VAS pain scores at 6 h while coughing was not different between groups (median, interquartile range), TAP, 27 (11 to 45) mm vs. placebo, 33 (20 to 49) mm (P = 0.20). Total 24-h morphine consumption was reduced in the TAP block group vs. placebo group, 30 (15 to 41) mg vs. 43 (30 to 67) mg, respectively (P = 0.008). This difference was most pronounced in the first postoperative hours. The remaining outcomes did not differ between groups. CONCLUSION: TAP block used in combination with paracetamol and ibuprofen did not reduce pain after laparoscopic colonic surgery. However, we found a 30% reduction in opioid use, most marked in the early postoperative period. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01418144).

The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial.

CONTEXT: The analgesic effect of transversus abdominis plane (TAP) block after inguinal hernia repair is unclear. OBJECTIVE: The aim of this randomised and double-blind study was to evaluate the analgesic effect of a TAP block in patients scheduled for primary inguinal hernia repair. The TAP block was evaluated versus placebo and versus an active comparator (ilioinguinal block and wound infiltration). DESIGN: Randomised controlled trial. SETTING: Single centre trial. Study period from June 2010 to November 2011. PATIENTS: Adults (18 to 75 years) with American Society of Anesthesiologists' status 1-3 scheduled for primary inguinal hernia repair as day case surgery were included in the study. INTERVENTIONS: Ninety patients were allocated to one of three groups: group TAP, group infiltration (ilioinguinal nerve block and wound infiltration) and group placebo. MAIN OUTCOME MEASURES: The primary outcome measure was pain scores while coughing between group TAP and group placebo calculated as area under the curve for the first 24  h (AUC24 h). Secondary outcomes were pain scores while coughing and at rest, opioid consumption and side effects in groups TAP, infiltration and placebo. RESULTS: Visual analogue pain scores while coughing and at rest demonstrated no difference between groups. Pain scores in groups infiltration, TAP and placebo were 19 versus 22 versus 15  mm at rest (P = 1.00) and 37 versus 41 versus 37  mm while coughing (P = 1.00). Pain scores at 6 h (AUC6 h) were significantly lower in group infiltration than in group TAP (10 versus 25 mm at rest, P < 0.001; 17 versus 40  mm while coughing, P < 0.001), and than in group placebo (10 versus 20  mm at rest, P = 0.003; 17 versus 38  mm while coughing, P < 0.001). Median morphine consumption was lower in group infiltration than in group placebo (0 versus 5 mg, P < 0.003). No differences among groups were demonstrated for ketobemidone consumption or side effects. CONCLUSION: Ultrasound-guided TAP block did not reduce postoperative pain after inguinal hernia repair. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01052285. EudraCT number 2010-018403-29.

The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial.

BACKGROUND: Laparoscopic cholecystectomy is associated with postoperative pain of moderate intensity in the early postoperative period. Recent randomized trials have demonstrated the efficacy of transversus abdominis plane (TAP) block in providing postoperative analgesia after abdominal surgery. We hypothesized that a TAP block may reduce pain while coughing and at rest for the first 24 postoperative hours, opioid consumption, and opioid side effects in patients undergoing laparoscopic cholecystectomy in day-case surgery. METHODS: In this randomized, double-blind study, 80 patients undergoing laparoscopic cholecystectomy in our day-case surgery unit were allocated to receive either bilateral ultrasound-guided posterior TAP blocks (20 mL 0.5% ropivacaine) or placebo blocks. Postoperative pain treatment consisted of oral acetaminophen 1000 mg × 4, oral ibuprofen 400 mg × 3, IV morphine (0-2 hours postoperatively), and oral ketobemidone (2-24 hours postoperatively). The primary outcome was postoperative pain scores while coughing calculated as area under the curve for the first 24 postoperative hours (AUC/24 h). Secondary outcomes were pain scores at rest (AUC/24 h), opioid consumption, and side effects. Patients were assessed 0, 2, 4, 6, 8, and 24 hours postoperatively. Group-wise comparisons of visual analog scale (VAS) pain (AUC/24 h) were performed with the 2-sample t test. Morphine and ketobemidone consumption were compared with the Mann-Whitney test for unpaired data. Categorical data were analyzed using the χ(2) test. RESULTS: The primary outcome variable, VAS pain scores while coughing (AUC/24 h), was significantly reduced in the TAP versus the placebo group (P = 0.04); group TAP: 26 mm (SD 13) (weighted average level) versus group placebo: 34 (18) (95% confidence interval): 0.5-15 mm). VAS pain scores at rest (AUC/24 h) showed no significant difference between groups. Median morphine consumption (0-2 hours postoperatively) was 7.5 mg (interquartile range: 5-10 mg) in the placebo group compared with 5 mg (interquartile range: 0-5 mg) in the TAP group (P < 0.001). The odds ratio of a random patient in group TAP having less morphine consumption than a random patient in group placebo was P (group TAP < group placebo) = 0.26 (confidence interval: 0.15, 0.37) where 0.5 represents no difference between groups. There were no between-group differences in total ketobemidone consumption, levels of nausea and sedation, number of patients vomiting, or consumption of ondansetron. CONCLUSIONS: TAP block after laparoscopic cholecystectomy may have some beneficial effect in reducing pain while coughing and on opioid requirements, but this effect is probably rather small.

Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study.

CONTEXT: Elevated blood levels of lidocaine and ropivacaine have been described after transversus abdominis plane (TAP) block. OBJECTIVE: To investigate the pharmacokinetic profile of ropivacaine after bilateral TAP blocks. DESIGN: Prospective observational pharmacokinetic study. SETTING: University teaching hospital in Copenhagen, Denmark. PATIENTS: Twenty-one adult patients presenting for abdominopelvic surgery with bilateral TAP blocks were enrolled. PROCEDURES: Ultrasound-guided TAP blocks with bilateral injections of 20 ml ropivacaine 0.5% w/v (total dose 200 mg). Blood was sampled at 0, 10, 30 and 60 min after TAP blocks. MEASURES: Total and free peak blood concentrations (Cmax) of ropivacaine. RESULTS: Data were analysed from N = 18 patients. The median dose of ropivacaine was 2.7 mg kg(-1) (range: 1.9-4.2 mg kg(-1)). Median total ropivacaine concentrations were 1.0, 1.6 and 1.7 µg ml(-1) at 10, 30 and 60 min, respectively. Six patients (33%) had Cmax values above 2.2 µg ml(-1) and the highest concentration measured was 5.1 µg ml(-1). One patient had a 33% drop in mean arterial blood pressure. CONCLUSION: TAP blocks with bilateral injections of 20 ml ropivacaine 0.5% w/v gave rise to potentially toxic peak blood concentrations of total ropivacaine in one-third of the patients.

Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial.

CONTEXT: Use of 80% oxygen during surgery has been suggested to reduce the risk of surgical wound infections, but this effect has not been consistently identified. The effect of 80% oxygen on pulmonary complications has not been well defined. OBJECTIVE: To assess whether use of 80% oxygen reduces the frequency of surgical site infection without increasing the frequency of pulmonary complications in patients undergoing abdominal surgery. DESIGN, SETTING, AND PATIENTS: The PROXI trial, a patient- and observer-blinded randomized clinical trial conducted in 14 Danish hospitals between October 2006 and October 2008 among 1400 patients undergoing acute or elective laparotomy. INTERVENTIONS: Patients were randomly assigned to receive either 80% or 30% oxygen during and for 2 hours after surgery. MAIN OUTCOME MEASURES: Surgical site infection within 14 days, defined according to the Centers for Disease Control and Prevention. Secondary outcomes included atelectasis, pneumonia, respiratory failure, and mortality. RESULTS: Surgical site infection occurred in 131 of 685 patients (19.1%) assigned to receive 80% oxygen vs 141 of 701 (20.1%) assigned to receive 30% oxygen (odds ratio [OR], 0.94; 95% confidence interval [CI], 0.72-1.22; P = .64). Atelectasis occurred in 54 of 685 patients (7.9%) assigned to receive 80% oxygen vs 50 of 701 (7.1%) assigned to receive 30% oxygen (OR, 1.11; 95% CI, 0.75-1.66; P = .60), pneumonia in 41 (6.0%) vs 44 (6.3%) (OR, 0.95; 95% CI, 0.61-1.48; P = .82), respiratory failure in 38 (5.5%) vs 31 (4.4%) (OR, 1.27; 95% CI, 0.78-2.07; P = .34), and mortality within 30 days in 30 (4.4%) vs 20 (2.9%) (OR, 1.56; 95% CI, 0.88-2.77; P = .13). CONCLUSION: Administration of 80% oxygen compared with 30% oxygen did not result in a difference in risk of surgical site infection after abdominal surgery. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00364741.

Effective dermatomal blockade after subcostal transversus abdominis plane block.

INTRODUCTION: The ultrasound-guided transversus abdominis plane (TAP) block is used to treat postoperative pain after abdominal surgery. Abdominal wall sensory nerves are anaesthetised by injecting local anaesthetics into the neurofascial plane between the internal oblique and the transversus abdominis muscles. Sensory assessment of a TAP block may guide the decision on the extent of the block. The purpose of this study was to investigate if the dermatomal extent of sensory blockade after injection of 20 ml 0.5% ropivacaine bilaterally into the TAP can be assessed using cold and pinprick sensation. MATERIAL AND METHODS: Subcostal TAP block was performed bilaterally in 20 awake patients scheduled for elective abdominal surgery. Sensory change in dermatomes T4-L4 was tested with pinprick using a blunt needle and cold disinfectant swabs after 10, 20 and 30 minutes. RESULTS: Data from 20 patients (40 blocks) were analysed. Eighteen patients registered sensory change after subcostal TAP block, and dermatomes T10-T12 were blocked after 30 minutes in all of these patients. Spread of sensory change to dermatomes T5-L3 was variable. CONCLUSION: This study confirmed that the dermatomal extent of a sensory blockade after a single-shot subcostal TAP block can be assessed using cold and pinprick sensation. FUNDING: not relevant. TRIAL REGISTRATION: The study was registered at clinicaltrials.gov with the registration number NCT01024868.

Resuscitation by hyperbaric exposure from a venous gas emboli following laparoscopic surgery.

Venous gas embolism is common after laparoscopic surgery but is only rarely of clinical relevance. We present a 52 year old woman undergoing laparoscopic treatment for liver cysts, who also underwent cholecystectomy. She was successfully extubated. However, after a few minutes she developed cardiac arrest due to a venous carbon dioxide (CO2) embolism as identified by transthoracic echocardiography and aspiration of approximately 7 ml of gas from a central venous catheter. She was resuscitated and subsequently treated with hyperbaric oxygen to reduce the size of remaining gas bubbles. Subsequently the patient developed one more episode of cardiac arrest but still made a full recovery. The courses of events indicate that bubbles had persisted in the circulation for a prolonged period. We speculate whether insufficient CO2 flushing of the laparoscopic tubing, causing air to enter the peritoneal cavity, could have contributed to the formation of the intravascular gas emboli. We conclude that persistent resuscitation followed by hyperbaric oxygen treatment after venous gas emboli contributed to the elimination of intravascular bubbles and the favourable outcome for the patient.