Comparaison of ESP Block and TAP Block

November 26, 2019 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital

ESP Versus TAP for Analgesia After Laparoscopic Cholecystectomy

This study aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will include patients scheduled for laparoscopic cholecystectomy, ASA status 1 or 2. patients will be randomized in 2 groups to recieve post operative analgesia with -ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.

or

-TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

Study Type

Interventional

Enrollment (Anticipated)

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

  • Tunisia
      • Tunis, Tunisia, 2046
        • Mongi Slim 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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients
  • ASA status I or II
  • scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

  • laparotomy
  • unplanned ICU admission

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESP group
ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
Procedure: ESP Block
ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
Experimental: TAP Block
TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%
Procedure: TAP Block
TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative analgesia
Time Frame: 24 hours after intervention
Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum)
24 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative analgesic consumption
Time Frame: 24 hours after intervention
Amount of Morphin needed for analgesia
24 hours after intervention

Collaborators and Investigators

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

Sponsor

Mongi Slim Hospital

Investigators

  • Principal Investigator: Mhamed Sami Mebazaa, Professor, Mongi Slim Hospital

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)

December 1, 2019

Primary Completion (Anticipated)

May 30, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESP in cholecystectomy

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.

Clinical Trials on Post Operative Pain

Clinical Trials on ESP Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe