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Completed

NCT Number: NCT03966092

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

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

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Key information

Conditions

Post Operative Pain Laparoscopic Colorectal Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU

Clermont-Ferrand, 63000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. NRS (Numeric rating scale)

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

    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

  2. Post Operative recovery: QUO-R4O questionnaire

    Time frame: At Day 1 and day 15 after surgery

    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.

  3. Time spent in recovery room (in minutes)

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

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: Coloqual

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 29, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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