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

Primary Purpose

Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasound guided external oblique intercostal plane block
Subcostal Transversus Abdominis Plan Block Group
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

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

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

Sites / Locations

  • Atatürk UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

External oblique intercostal plane block

Subcostal Transversus Abdominis Plan Block Group

Arm Description

Ultrasound-guided External oblique intercostal plane block before surgery

Ultrasound-guided Subcostal Transversus Abdominis Plan Block Group

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Full Information

First Posted
November 21, 2022
Last Updated
December 1, 2022
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05632991
Brief Title
External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy
Official Title
Ultrasound Guided External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
External oblique intercostal plane block
Arm Type
Active Comparator
Arm Description
Ultrasound-guided External oblique intercostal plane block before surgery
Arm Title
Subcostal Transversus Abdominis Plan Block Group
Arm Type
Active Comparator
Arm Description
Ultrasound-guided Subcostal Transversus Abdominis Plan Block Group
Intervention Type
Other
Intervention Name(s)
ultrasound guided external oblique intercostal plane block
Intervention Description
ultrasound guided external oblique intercostal plane block 20 ml local anesthetic each side
Intervention Type
Other
Intervention Name(s)
Subcostal Transversus Abdominis Plan Block Group
Intervention Description
ultrasound guided Subcostal Transversus Abdominis Plan Block Group 20 ml local anesthetic each side
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
First 24 hours total fentanyl consumption with patient controlled analgesia
Time Frame
first 24 hours
Secondary Outcome Measure Information:
Title
Visual analog pain score
Description
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
Time Frame
postextubation 0-24 hours

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ahiskalioglu
Phone
+905444424831
Email
aliahiskalioglu@hotmail.com
Facility Information:
Facility Name
Atatürk University
City
Erzurum
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ahisaklioglu
Phone
+905444424831
Ext
+905444424831
Email
aliahiskalioglu@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24400824
Citation
Woldu SL, Weinberg AC, Bergman A, Shapiro EY, Korets R, Motamedinia P, Badani KK. Pain and analgesic use after robot-assisted radical prostatectomy. J Endourol. 2014 May;28(5):544-8. doi: 10.1089/end.2013.0783. Epub 2014 Jan 30.
Results Reference
background
PubMed Identifier
23797751
Citation
Leitao MM Jr, Malhotra V, Briscoe G, Suidan R, Dholakiya P, Santos K, Jewell EL, Brown CL, Sonoda Y, Abu-Rustum NR, Barakat RR, Gardner GJ. Postoperative pain medication requirements in patients undergoing computer-assisted ("Robotic") and standard laparoscopic procedures for newly diagnosed endometrial cancer. Ann Surg Oncol. 2013 Oct;20(11):3561-7. doi: 10.1245/s10434-013-3064-9.
Results Reference
background

Learn more about this trial

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

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