Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery.
- Conditions
- Post Operative PainLaparoscopic Colorectal Surgery
- Interventions
- Procedure: Quadratus lumborum block
- Registration Number
- NCT03966092
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
The primary purpose of COLOQUAL study is to demonstrate the superiority of analgesic effect of a bilateral quadratus lumborum block (QLB), performed at the end of laparoscopic colorectal surgery, compared to standard of care.
The investigators hypothesized that a bilateral quadratus lumborum block performed at the end of laparoscopic colorectal surgery would reduce the incidence of post operative pain, time spent in recovery room, improve patient's satisfaction, and reduce hospitalisation time
- Detailed Description
Visits:
* The patient will arrive in the department the day before the surgical intervention (Day-1). During this preoperative visit (Day-1), the investigator
* will preselect potentially eligible patients
* will offer to participate to this study
* will give the notice form to the patients
* will present the research: objectives, benefits and constraints for the patients
* The intervention day (Day 0):
The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.
The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.
Surgical Intervention (Day 1):
All patients will receive standard anaesthesia using sufentanyl, propopol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score. Anti microbial prophylaxis is performed according recommendations.
All patients will receive post operative multimodal analgesia using intravenous lidocaine, acetaminophene, ketaminophene, and morphine if NRS (numerating rating scale) \> 3 At the end of the surgery, patients in the experimental group will receive a bilateral ultrasound guided quadratus lumborum block with 15 ml of 3,75 mg/mg of ropivacaine. Patients in the control group will not receive the block
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Age > 18 years old
- Patients operated of a scheduled laparoscopic colorectal surgery
- Patients having given consent in the mannen described in Article L1122-1-1 of the Public Health Code
- Patients affiliated with asocial security regimen or beneficiary of such a regimen
- Renal insufficiency (ie glomerular filtration output < 35 ml/min)
- Patients with chronic inflammatory bowel disease
- Body mass index > 35 kg/m2
- Chronic pain with opiates
- Patients with cognitive troubles
- Coagulation disorders (platelets count < 80G/L, PT< 50%, V factor < 50%)
- Pregnancy
- Breastfeeding
- Local anesthesics (amide class) allergy
- Laparotomy conversion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QLB block Quadratus lumborum block Patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen and morphine. Antimicrobial prophylaxis is performed according to recommendations. In addition, patients receiving a bilateral QLB at the end of the surgery
- Primary Outcome Measures
Name Time Method Morphine Consumption in milligramme 8 AM (ante meridiem) the day after surgery Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the nurse in charge of the patient
- Secondary Outcome Measures
Name Time Method NRS (Numeric rating scale) At the entrance of recovery room, at day 1 and Day 2 after surgery Numerating rating score evaluating pain and variating from 0 (No pain) to 10 (Maximum Pain), done by nurses in operating room and in post operative surgical service
Post Operative recovery: QUO-R4O questionnaire At Day 1 and day 15 after surgery Quo 40 score is a postoperative recovery score above 200 points (40 is worst score and 200 the best score) validated by Myles et al in 2001.
Time spent in recovery room (in minutes) At the output of recovery room ie until 6 hours after intervention Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is \>9) performed by nurses
Trial Locations
- Locations (1)
CHU
🇫🇷Clermont-Ferrand, France