Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy

August 18, 2020 updated by: Sameh Emile, Mansoura University

Impact of Laparoscopic Versus Ultrasound-Guided Subcostal Transversus Abdominis Plane Block on Pain and Recovery After Laparoscopic Cholecystectomy: A Randomized Double-Blinded Controlled Study

Zaghiyan et al hypothesized that Laparoscopic TAP was noninferior to US-TAP and performed a randomized clinical trial comparing Laparoscopic TAP, US-TAP, and no TAP in minimally invasive colorectal surgery. The authors reported that LTAP was superior to UTAP in achieving pain control and minimizing opioid use in the first 24 hours after colorectal surgery.

This prospective randomized, controlled trial will be performed to assessed the efficacy of laparoscopic subcostal TAP block (LSTAP) compared to ultrasound-guided subcostal TAP (USTAP) block after laparoscopic cholecystectomy regarding postoperative pain scores in the first 24-hours after the intervention and analgesic requirements.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

94

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

  • Egypt
    • Dakahlia
      • Mansourah, Dakahlia, Egypt, 35516
        • Recruiting
        • Mansoura University Hospital

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive adult patients of either gender who will undergo laparoscopic cholecystectomy will be recruited to the study.

Exclusion Criteria:

  • Pregnant women
  • Patients who will undergo open cholecystectomy
  • Patients who will need conversion to conventional open cholecystectomy
  • Patients with ASA III classification or higher
  • Patients who will undergo laparoscopic cholecystectomy together with other abdominal interventions.

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: Laparoscopic TAP
Subcostal TAP block will be performed after surgery under laparoscopic guidance
Procedure: Laparoscopic TAP
Subcostal TAP block will be performed after surgery under laparoscopic guidance
Active Comparator: US TAP
Subcostal TAP block will be performed after surgery under ultrasound guidance
Procedure: US TAP
Subcostal TAP block will be performed after surgery under US guidance
No Intervention: No TAP
No TAP block will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 24 hours after cholecystectomy
pain will be assessed with visual analogue scale from 0-10
24 hours after cholecystectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic requirement
Time Frame: 24 hours after cholecystectomy
the need for intravenous analgesia after surgery calculated as the cumulative dose of analgesic administered over 24 hours
24 hours after cholecystectomy

Collaborators and Investigators

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

Sponsor

Mansoura University

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)

February 17, 2020

Primary Completion (Anticipated)

February 28, 2021

Study Completion (Anticipated)

March 30, 2021

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mansoura124

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

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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