Clinical trial NCT03966092: Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery.
Official title: Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery: a Prospective Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Laparoscopic Colorectal Surgery
Keywords: Prospective randomized pilot study
Quadratus lumborum block
Quo R 40 score
Post operative pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in 2 groups

* Control group (usual practice): 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.
* Experimental group: 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 this group, a bilateral quadratus lumborum block, using 20 ml of ropivacaine 3, 75 mg/ml is performed at the end of surgery, using ultrasound guidance.
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Morphine Consumption in milligramme
timeFrame: 8 AM (ante meridiem) the day after surgery
Secondary outcomes:
measure: NRS (Numeric rating scale)
timeFrame: At the entrance of recovery room, at day 1 and Day 2 after surgery
measure: Post Operative recovery: QUO-R4O questionnaire
timeFrame: At Day 1 and day 15 after surgery
measure: Time spent in recovery room (in minutes)
timeFrame: At the output of recovery room ie until 6 hours after intervention
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Marie Vignaud
role: PRINCIPAL_INVESTIGATOR
References: