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Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies

NCT ID: NCT06172465

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2024-11-25

Brief Summary

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Laparoscopic cholecystectomy (LC) surgery causes postoperative severe pain. As part of multimodal analgesia aimed at reducing postoperative opioid consumption and providing effective analgesia, ultrasound (US)-guided transversus abdominis plane block (TAP) and external oblique intercostal plane block (EOIPB) will be applied as regional anesthesia methods. There is no study in the literature comparing OSTAP and EOIP blocks, and our goal is to evaluate the analgesic effectiveness between OSTAP and EOIP blocks in LC surgeries.

Detailed Description

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Patients will be divided into two groups, and general anesthesia will be administered to all. Before extubation, one group will receive an external oblique intercostal nerve block, while the other group will receive an oblique subcostal transversus abdominis plane block. The randomization of the study will be carried out by a computer-generated randomization code (computer-generated) by a physician who will not be involved in patient follow-up. The interfascial plane block (either external oblique intercostal block or oblique subcostal block) will be provided to an anesthesiologist in a sealed envelope by an independent assistant staff member outside the study. The patient will not be aware of which block is applied. The anesthesiologist performing the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be conducted by another anesthesiologist unaware of the study.

For standardization, the block procedure will be performed by an experienced anesthesiologist who has completed at least 20 previous successful and uncomplicated procedures.

Conditions

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Analgesia Pain, Post Operative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two interventional group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The anesthetist who will perform the blocks 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.

Study Groups

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group external oblique intercostal plane block

While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules at end of the surgery.

Group Type ACTIVE_COMPARATOR

EOIP

Intervention Type OTHER

Ultrasound guided External oblique intercostal block will be performed bilaterally.

group oblique subcostal transversus abdominis plane block

Ultrasound-guided bilateral OSTAP block performed at end of the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed

Group Type ACTIVE_COMPARATOR

OSTAP

Intervention Type OTHER

Ultrasound guided oblique subcostal transversus abdominis plane block will be performed bilaterally.

Interventions

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EOIP

Ultrasound guided External oblique intercostal block will be performed bilaterally.

Intervention Type OTHER

OSTAP

Ultrasound guided oblique subcostal transversus abdominis plane block will be performed bilaterally.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsun University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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gamze MD ertaş, specialist

Role: PRINCIPAL_INVESTIGATOR

Samsun University

Locations

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Samsun University

Samsun, Ilkadım, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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trunk block

Identifier Type: -

Identifier Source: org_study_id