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Postoperative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgery

Primary Purpose

Analgesia, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pain Management
Sponsored by
Samsun University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Analgesia focused on measuring External oblique intercostal block, Pain management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI < 35 kg/m²
  • Patients with ASA scores I and II

Exclusion Criteria:

  • Patients who do not want to be included in the study
  • Psychiatric and neurological disease with blurred consciousness
  • Patients with ASA > 3
  • BMI > 35 kg/m²
  • Abnormality in coagulation parameters
  • History of allergy to local anesthetic drugs
  • Infection at the injection site

Sites / Locations

  • Samsun University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

External Oblique Intercostal Block Group

Control

Arm Description

While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening.

Patients in the control group will not have any intervention concerning regional anesthesia.

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
Contramal consumption in the first 24 hours after surgery

Secondary Outcome Measures

NRS scores
NRS scores in the first 24 hours after surgery
Quality of recovery
QR15 scores
Nausea and vomiting
Nausea and vomiting scores in the first 24 hours

Full Information

First Posted
June 28, 2022
Last Updated
July 20, 2023
Sponsor
Samsun University
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1. Study Identification

Unique Protocol Identification Number
NCT05444985
Brief Title
Postoperative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgery
Official Title
Post-operative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgeries.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2022 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
May 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsun 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 aim of our study is to reduce postoperative pain by performing external oblique intercostal block in L/S cholecystectomy surgeries. Our main goal is to provide well managed post-operative analgesia.
Detailed Description
The patients will be divided into two groups and general anesthesia will be applied to all of them. There will be no regional anesthetic technique to be performed, on the other hand, external oblique intercostal nerve block will be applied to patients in the other group before the patients are extubated. Study randomization is done with computer-generated randomization codes (computer-generated) by a physician who will not participate in patient follow-up. Interfascial plane block (external oblique intercostal block) will be given to the anesthesiologist in a sealed envelope by an independent assistant staff outside the study, the patient will not know which block is applied. The anesthetist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study. For the standardization, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 previous successful and uncomplicated procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Pain, Postoperative
Keywords
External oblique intercostal block, Pain management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One interventional group and one control group.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The anesthetist who will perform the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External Oblique Intercostal Block Group
Arm Type
Experimental
Arm Description
While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control group will not have any intervention concerning regional anesthesia.
Intervention Type
Other
Intervention Name(s)
Pain Management
Intervention Description
Regional anesthetic techniques for peri-operative pain management after surgery.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Contramal consumption in the first 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
NRS scores
Description
NRS scores in the first 24 hours after surgery
Time Frame
At 1,3, 6, 12, 18, 24 hours
Title
Quality of recovery
Description
QR15 scores
Time Frame
24 hours
Title
Nausea and vomiting
Description
Nausea and vomiting scores in the first 24 hours
Time Frame
At 1,3, 6, 12, 18, 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI < 35 kg/m² Patients with ASA scores I and II Exclusion Criteria: Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA > 3 BMI > 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Kusderci, M.D.
Organizational Affiliation
Samsun University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsun University
City
Samsun
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgery

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