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

Sponsor

Samsun University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05444985

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

15.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia Pain, Postoperative	Other: Pain Management	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

One interventional group and one control group.One interventional group and one control group.

Masking:

Triple (Participant, Care Provider, Outcomes 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.

Primary Purpose:

Supportive Care

Official Title:

Post-operative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgeries.

Actual Study Start Date :

Jul 17, 2022

Anticipated Primary Completion Date :

Oct 17, 2022

Anticipated Study Completion Date :

Dec 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: External Oblique Intercostal Block Group While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening.	Other: Pain Management Regional anesthetic techniques for peri-operative pain management after surgery.
Active Comparator: Control Patients in the control group will not have any intervention concerning regional anesthesia.	Other: Pain Management Regional anesthetic techniques for peri-operative pain management after surgery.

Arm

Intervention/Treatment

Experimental: External Oblique Intercostal Block Group

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

Other: Pain Management

Regional anesthetic techniques for peri-operative pain management after surgery.

Active Comparator: Control

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

Other: Pain Management

Regional anesthetic techniques for peri-operative pain management after surgery.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

NRS scores [At 1,3, 6, 12, 18, 24 hours]
NRS scores in the first 24 hours after surgery
Quality of recovery [24 hours]
QR15 scores
Nausea and vomiting [At 1,3, 6, 12, 18, 24 hours]
Nausea and vomiting scores in the first 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsun University	Samsun		Turkey

Sponsors and Collaborators

Samsun University

Investigators

Principal Investigator: Hatice Kusderci, M.D., Samsun University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samsun University

ClinicalTrials.gov Identifier:

NCT05444985

Other Study ID Numbers:

HATICE55

First Posted:

Jul 6, 2022

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Samsun University

External oblique intercostal block

Pain management

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jul 22, 2022