Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery. (Coloqual)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Laparoscopic Colorectal Surgery; Post Operative Pain

Treatments: Procedure: Quadratus lumborum block

Study type: Interventional

Funder types: Other

Identifiers

NCT03966092

2019-000277-23 (Other Identifier)

RBHP 2018 VIGNAUD_Coloqual

Details and patient eligibility

About

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

Full 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

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Usual practice

No Intervention group

Description:

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

QLB block

Experimental group

Description:

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

Treatment:

Procedure: Quadratus lumborum block