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

Post Operative Pain Clinical Trial

— Coloqual  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966092
• Other study ID #: RBHP 2018 VIGNAUD_Coloqual
• Secondary ID: 2019-000277-23
• Status: Completed
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: April 17, 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Colorectal Surgery
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	At the entrance of recovery room, at day 1 and Day 2 after surgery
Secondary	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.	At Day 1 and day 15 after surgery
Secondary	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	At the output of recovery room ie until 6 hours after intervention