Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Laparoscopic Cholecystectomy

April 11, 2021 updated by: Mai Elsaid Hamada, Tanta University

Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Surgeries: A Randomized Controlled Trial

The aim of this study is to compare between the efficacy of ultrasound guided erector spinae plane block and ultrasound guided quadratus lumborum block in managing acute postoperative pain in patients undergoing laparoscopic cholecystectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 21-65 years
  • both genders
  • American Society of Anesthesiology (ASA) class I-II
  • Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

  • Patient refusal.
  • Coagulopathy.
  • History of allergy to local anaesthetic.
  • History of liver or renal pathology affecting drug elimination
  • Mental dysfunction or cognitive disorders.
  • Use of medication such as gabapentin-pregabalin that could affect pain perception.
  • Body Mass Index > 40 kg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
patients will receive general anesthesia only.
Other: Control group
patients will receive general anesthesia only.
Other Names:
  • Group C
Experimental: Erector spinae plane block group
patients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%)
Procedure: Erector spinae plane block group
patients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%)
Other Names:
  • group ESPB
Experimental: Quadratus lumborum block group
patients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%)
Procedure: Quadratus lumborum block group
patients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%)
Other Names:
  • group QLB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of postoperative pain in the first 24 hours post-operative
Time Frame: first 24 hours post-operative
Postoperative pain will be assessed by the numerical rating scale (NRS); 0 no pain while 10 is the maximum pain) after discharge to the ward ,and at 6, 12, 18, 24 hours.
first 24 hours post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic requirement
Time Frame: first 24 hours post-operative
Intravenous morphine 2 mg will be given when the numerical rating scale (NRS) equal or above 4
first 24 hours post-operative
Total dose of intraoperative consumption of fentanyl
Time Frame: intraoperative
Fentanyl 0.5 μg/kg will be given if there was increase in heart rate or mean arterial blood pressure more than 20% (after exclusion of other causes than pain).
intraoperative
Total dose of rescue analgesia in the first 24hr postoperative
Time Frame: first 24 hours post-operative
Total morphine consumption 24 hours after surgery will be recorded. Intravenous morphine 2 mg will be given when the numerical rating scale (NRS) equal or above 4
first 24 hours post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Mai E Hamada, MBBCH, Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 11, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 34503/2/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data are available upon reasonable request from the principal investigator

IPD Sharing Time Frame

6 months after the end of study For 2 years

IPD Sharing Access Criteria

Data are available upon reasonable request from the principal investigator

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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