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OpenTrials
Completed

NCT Number: NCT06172465

Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun University

Samsun, Ilkadım, 55100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOIP

Other

Ultrasound guided External oblique intercostal block will be performed bilaterally.

OSTAP

Other

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

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: up to 24 hours

    tramadol consumption in the first 24 hours after surgery

Secondary outcomes

  1. NRS scores

    Time frame: At 1,3, 6, 12, 18, 24 hours

    NRS scores in the first 24 hours after surgery

  2. Quality of recovery

    Time frame: 24 hours

    QR15 scores

  3. Nausea and vomiting

    Time frame: At 1,3, 6, 12, 18, 24 hours

    Nausea and vomiting scores in the first 24 hours

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Comparison of Bilateral Oblique Transversus Abdominis Plane Block (OSTAPB) and Bilateral External Oblique Intercostal Plane Block (EOIPB) in Laparoscopic Cholecystectomies

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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