Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery

Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery.A Prospective Randomizes Controlled Study.

The purpose of this study was to determine the effectiveness of pre-emptive Quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures.

Study Overview

• Status: Completed
• Conditions: Pain; Postoperative
• Intervention / Treatment: Drug: Bupivacaine; Procedure: US-guided Quadratus lumborum block.; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Anesthesiology department, Faculty of Medicine, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients included in this study are

• Both genders
• Age between 18-50 years
• Those undergoing laparoscopic bariatric surgery (as laparoscopic sleeve gastrectomy or gastric bypass).
• BMI ≥ 35 Kg/m2 with comorbidity or ≥ 40 Kg/m2 without comorbidity.

Exclusion Criteria:

Patients excluded from this study were

• those with obstructive sleep apnoea and/or Pickwickian syndrome.
• if the laparoscopy procedure was converted to laparotomy.
• patients suffering from known coagulation defects.
• known hypersensitivity to bupivacaine, or those with contraindication to the use of NSAIDS.
• Presence of sepsis at the site of injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Quadratus lumborum block with bupivacaine; After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine where a solution of 0.25% bupivacaine 0.2 ml /kg (lean body weight) is used on each side with care not to exceed the toxic dose.	Drug: Bupivacaine; Bupivacaine; Procedure: US-guided Quadratus lumborum block.; Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery
Placebo Comparator: Group Quadratus lumborum block with saline; After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine.A volume of 0.2ml/kg normal saline will given for each side.	Procedure: US-guided Quadratus lumborum block.; Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery; Drug: Saline; normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain severity	Assessment of analgesia intraoperatively and for the first 24 hours postoperatively using the numerical ratingscale (NRS)score .The scale ranges from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain imaginable.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative hemodynamics	Mean arterial pressure (MAP) in mmHg.	24 hours postoperatively
Postoperative analgesic needs	Time to first analgesic requirement in hours	24 hours postoperatively.
Total dose of opioids	Total dose of opioids received in mg	24 hours postoperatively.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ahmed S. Omran, MD, Anesthesiology department, Faculty of Medicine, Ain Shams University; Principal Investigator: Doaa M. Kamal El-Din, MD, Anesthesiology department, Faculty of Medicine, Ain Shams Unive; Principal Investigator: Walid H. Nofal, MD, Anesthesiology department, Faculty of Medicine, Ain Shams Unive

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: laparoscopic bariatric surgery; Quadratus lumborum block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: FMASU R 18/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No