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

Primary Purpose

Post Operative Pain, Laparoscopic Colorectal Surgery

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quadratus lumborum block
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring Prospective randomized pilot study, Quadratus lumborum block, Quo R 40 score, Post operative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual practice

QLB block

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

NRS (Numeric rating scale)
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
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)
Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses

Full Information

First Posted
May 23, 2019
Last Updated
April 17, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03966092
Brief Title
Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery.
Acronym
Coloqual
Official Title
Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery: a Prospective Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Laparoscopic Colorectal Surgery
Keywords
Prospective randomized pilot study, Quadratus lumborum block, Quo R 40 score, Post operative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
During the assess period, the participant and the research staff involved in the data collection will be blinded to the randomization group
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual practice
Arm Type
No Intervention
Arm 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
Arm Title
QLB block
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine Consumption in milligramme
Description
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
Time Frame
8 AM (ante meridiem) the day after surgery
Secondary Outcome Measure Information:
Title
NRS (Numeric rating scale)
Description
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
Time Frame
At the entrance of recovery room, at day 1 and Day 2 after surgery
Title
Post Operative recovery: QUO-R4O questionnaire
Description
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 Frame
At Day 1 and day 15 after surgery
Title
Time spent in recovery room (in minutes)
Description
Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses
Time Frame
At the output of recovery room ie until 6 hours after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Vignaud
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

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

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