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

NCT ID: NCT03966092

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2023-04-17

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

Conditions

Post Operative Pain; Laparoscopic Colorectal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

QLB 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

Group Type: EXPERIMENTAL

Quadratus lumborum block

Intervention Type: PROCEDURE

• Bilateral Quatratus lumborum block is performed with ultra sound guidance. The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen). Laterally, these three are merging to from fascia transversalis. Under fascia transversalis, we can see quadratus lumborum muscle. Punction point in lateral, 1cm in the plan separating quadratus lumborum block and fascia transversalis
• 20 ml of ropivacaïne 3.75mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised.

Interventions

Quadratus lumborum block

• Bilateral Quatratus lumborum block is performed with ultra sound guidance. The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen). Laterally, these three are merging to from fascia transversalis. Under fascia transversalis, we can see quadratus lumborum muscle. Punction point in lateral, 1cm in the plan separating quadratus lumborum block and fascia transversalis
• 20 ml of ropivacaïne 3.75mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Vignaud

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2019-000277-23

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2018 VIGNAUD_Coloqual

Identifier Type: -

Identifier Source: org_study_id