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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05444985
Other study ID # HATICE55
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 17, 2022
Est. completion date May 9, 2023

Study information

Verified date July 2023
Source Samsun University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 9, 2023
Est. primary completion date May 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pain Management
Regional anesthetic techniques for peri-operative pain management after surgery.

Locations

Country Name City State
Turkey Samsun University Samsun

Sponsors (1)

Lead Sponsor Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative opioid consumption Contramal consumption in the first 24 hours after surgery 24 hours
Secondary NRS scores NRS scores in the first 24 hours after surgery At 1,3, 6, 12, 18, 24 hours
Secondary Quality of recovery QR15 scores 24 hours
Secondary Nausea and vomiting Nausea and vomiting scores in the first 24 hours At 1,3, 6, 12, 18, 24 hours
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