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Clinical Trials/NCT03966092
NCT03966092
Completed
Not Applicable

Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery: a Prospective Randomized Pilot Study

University Hospital, Clermont-Ferrand1 site in 1 country44 target enrollmentJune 24, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Operative Pain
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
44
Locations
1
Primary Endpoint
Morphine Consumption in milligramme
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 24, 2019
End Date
April 17, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Morphine Consumption in milligramme

Time Frame: 8 AM (ante meridiem) the day after surgery

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 Outcomes

  • 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 Sites (1)

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