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Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy

Primary Purpose

Cholecystitis; Gallstone

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic TAP
US TAP
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis; Gallstone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Laparoscopic TAP

US TAP

No TAP

Arm Description

Subcostal TAP block will be performed after surgery under laparoscopic guidance

Subcostal TAP block will be performed after surgery under ultrasound guidance

No TAP block will be performed

Outcomes

Primary Outcome Measures

Pain score
pain will be assessed with visual analogue scale from 0-10

Secondary Outcome Measures

Analgesic requirement
the need for intravenous analgesia after surgery calculated as the cumulative dose of analgesic administered over 24 hours

Full Information

First Posted
February 17, 2020
Last Updated
August 18, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04276285
Brief Title
Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy
Official Title
Impact of Laparoscopic Versus Ultrasound-Guided Subcostal Transversus Abdominis Plane Block on Pain and Recovery After Laparoscopic Cholecystectomy: A Randomized Double-Blinded Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis; Gallstone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic TAP
Arm Type
Active Comparator
Arm Description
Subcostal TAP block will be performed after surgery under laparoscopic guidance
Arm Title
US TAP
Arm Type
Active Comparator
Arm Description
Subcostal TAP block will be performed after surgery under ultrasound guidance
Arm Title
No TAP
Arm Type
No Intervention
Arm Description
No TAP block will be performed
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic TAP
Intervention Description
Subcostal TAP block will be performed after surgery under laparoscopic guidance
Intervention Type
Procedure
Intervention Name(s)
US TAP
Intervention Description
Subcostal TAP block will be performed after surgery under US guidance
Primary Outcome Measure Information:
Title
Pain score
Description
pain will be assessed with visual analogue scale from 0-10
Time Frame
24 hours after cholecystectomy
Secondary Outcome Measure Information:
Title
Analgesic requirement
Description
the need for intravenous analgesia after surgery calculated as the cumulative dose of analgesic administered over 24 hours
Time Frame
24 hours after cholecystectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh H Emile, M.D.
Phone
+201006267150
Email
sameh200@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D
Phone
01006267150
Email
sameh200@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy

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