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

NCT03966092 | Completed

• 2 other identifiers: RBHP 2018 VIGNAUD_Coloqual2019-000277-23
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain; Laparoscopic Colorectal Surgery

Keywords

Prospective randomized pilot study; Quadratus lumborum block; Quo R 40 score; Post operative pain

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption in milligramme

  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

  8 AM (ante meridiem) the day after surgery

Secondary Outcomes (3)

• NRS (Numeric rating scale)

  At the entrance of recovery room, at day 1 and Day 2 after surgery

• Post Operative recovery: QUO-R4O questionnaire

  At Day 1 and day 15 after surgery

• Time spent in recovery room (in minutes)

  At the output of recovery room ie until 6 hours after intervention

Study Arms (2)

Usual practice

NO INTERVENTION

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

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

Procedure: Quadratus lumborum block

Interventions

Quadratus lumborum block 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.

QLB block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marie Vignaud

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During the assess period, the participant and the research staff involved in the data collection will be blinded to the randomization group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 29, 2019
• Study Start: June 24, 2019
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

FR (1)