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Completed

NCT Number: NCT04294329

Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Postoperative Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesiology department, Faculty of Medicine, Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

US-guided Quadratus lumborum block.

Procedure

Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery

Bupivacaine

Drug

Bupivacaine

Saline

Drug

normal saline

Primary outcomes

  1. Postoperative pain severity

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. Intraoperative hemodynamics

    Time frame: 24 hours postoperatively

    Mean arterial pressure (MAP) in mmHg.

  2. Postoperative analgesic needs

    Time frame: 24 hours postoperatively.

    Time to first analgesic requirement in hours

  3. Total dose of opioids

    Time frame: 24 hours postoperatively.

    Total dose of opioids received in mg

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2020
Registry last updated
Aug 25, 2020

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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