External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

March 29, 2024 updated by: Ali Ahiskalioglu, Ataturk University

Ultrasound Guided External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Prospective Randomized Study

The laparoscopic approach has become the gold standard for many abdominal surgical procedures, including cholecystectomy. Compared to laparotomy, laparoscopy allows smaller incisions, reduces perioperative stress response, reduces postoperative pain, and results in shorter recovery time.

However, anaesthesia concerns in patients undergoing laparoscopic surgery are different from patients undergoing open abdominal surgery.

The aim of this study is to investigate the effect of the external oblique intercostal block, which is a new block, on postoperative pain score and opioid consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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 Locations

  • Turkey
      • Erzurum, Turkey
        • Ataturk University

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologist's physiologic state I-III patients
  • Laparoscopic cholecystectomy

Exclusion Criteria:

  • Chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: External oblique intercostal plane block
Ultrasound-guided External oblique intercostal plane block before surgery
Other: ultrasound guided external oblique intercostal plane block
ultrasound guided external oblique intercostal plane block 20 ml local anesthetic each side
Active Comparator: Subcostal Transversus Abdominis Plan Block Group
Ultrasound-guided Subcostal Transversus Abdominis Plan Block Group
Other: Subcostal Transversus Abdominis Plan Block Group
ultrasound guided Subcostal Transversus Abdominis Plan Block Group 20 ml local anesthetic each side

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: first 24 hours
First 24 hours total fentanyl consumption with patient controlled analgesia
first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain score
Time Frame: postextubation 0-24 hours
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
postextubation 0-24 hours

Collaborators and Investigators

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

Sponsor

Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ataunilapcholecystectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

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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