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Comparaison of ESP Block and TAP Block

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
ESP Block
TAP Block
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Laparoscopic cholecystectomy, Post Operative, Analgesia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • laparotomy
  • unplanned ICU admission

Sites / Locations

  • Mongi Slim Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESP group

TAP Block

Arm Description

ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.

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

Outcomes

Primary Outcome Measures

Post Operative analgesia
Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum)

Secondary Outcome Measures

post operative analgesic consumption
Amount of Morphin needed for analgesia

Full Information

First Posted
November 22, 2019
Last Updated
November 26, 2019
Sponsor
Mongi Slim Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04176770
Brief Title
Comparaison of ESP Block and TAP Block
Official Title
ESP Versus TAP for Analgesia After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Laparoscopic cholecystectomy, Post Operative, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESP group
Arm Type
Experimental
Arm Description
ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
Arm Title
TAP Block
Arm Type
Experimental
Arm Description
TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%
Intervention Type
Procedure
Intervention Name(s)
ESP Block
Intervention Description
ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
Intervention Type
Procedure
Intervention Name(s)
TAP Block
Intervention Description
TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%
Primary Outcome Measure Information:
Title
Post Operative analgesia
Description
Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum)
Time Frame
24 hours after intervention
Secondary Outcome Measure Information:
Title
post operative analgesic consumption
Description
Amount of Morphin needed for analgesia
Time Frame
24 hours after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients ASA status I or II scheduled for laparoscopic cholecystectomy Exclusion Criteria: laparotomy unplanned ICU admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mhamed Sami Mebazaa, professor
Phone
0021622252589
Email
msmebazaa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Asma Ben Souissi, Ass Prof
Phone
0021698336883
Email
bsouissiasma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami Mebazaa, Professor
Organizational Affiliation
Mongi Slim Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongi Slim Hospital
City
Tunis
ZIP/Postal Code
2046
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparaison of ESP Block and TAP Block

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