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Completed

NCT Number: NCT05444985

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

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.

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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, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Pain management

Other

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

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: 24 hours

    Contramal 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

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Jul 21, 2023

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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