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Clinical Trials/NCT05536557
NCT05536557
Completed
N/A

Ultrasound-guided Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial

Karaman Training and Research Hospital1 site in 1 country80 target enrollmentSeptember 15, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Laparoscopic Cholecystectomy
Sponsor
Karaman Training and Research Hospital
Enrollment
80
Locations
1
Primary Endpoint
Opioid consumption
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study will define the postoperative analgesic effect of ultrasound-guided bilateral External Oblique İntercostal (EOI) Plane Block and compare the control group in patients undergoing laparoscopic cholecystectomy.

The aim of this study is to compare postoperative opioid consumption of EOI plane block versus control group. It is hypothesized that postoperative opioid use will be less in patients with EOI plane block than in patients who only receive routine multimodal analgesia.

Detailed Description

Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (LC). Regional blocks used in addition to multimodal analgesia for postoperative pain after LC usually block the anterior branches of the intercostal nerves. After it was suggested by Hamilton et al. in 2018 that it could block the lateral cutaneous branches between T7-T11 intercostal nerve by administering local anesthetic to the thoracic facial plane and could be used in lateral abdominal surgeries, the EOI plane block has become a block that can be used for analgesic purposes in upper and lateral abdominal surgeries. Blocking the anterior and lateral branches together may produce analgesia in a wider area, resulting in less postoperative opioid consumption. This study will be conducted as a single-center, prospective, randomized trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, EOI Plane Block will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. An anesthesiologist who performed blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative opioid consumption,pain scores, nausea and vomiting, antiemetic use, and Quality of Recovery score will be blinded to group assignment.

Registry
clinicaltrials.gov
Start Date
September 15, 2022
End Date
November 24, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karaman Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

muhammet korkusuz

Principal Investigator, MD

Karaman Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study.

Exclusion Criteria

  • presence of coagulation disorder
  • infection at the injection site of the block
  • known allergy to local anesthetics
  • advanced hepatic or renal failure
  • can not communicate in Turkish
  • history of abdominal surgery or trauma
  • conversion of laparoscopic to open surgery
  • consumption of any pain killers within the 24 h before the operation
  • chronic opioid consumption
  • pregnancy

Outcomes

Primary Outcomes

Opioid consumption

Time Frame: Postoperative 24 hours

If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.

Secondary Outcomes

  • Adverse events(Postoperative 24 hours)
  • Sedation score(Postoperative 24 hour)
  • Numerical Rating Scale scores(Postoperative 24 hours)
  • Metoclopromide consumption(Postoperative 24 hours)
  • Quality of recovery levels between groups by using QoR-15 questionnaire(Postoperative 24th hour)
  • Time to first rescue analgesic(Postoperative 24 hours)

Study Sites (1)

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