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

NCT05444985 — Not applicable, Completed, 80 participants, Samsun University

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

RegistryNCT05444985
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, supportive care
Enrollment80 (Actual)
SponsorSamsun University (Other)
ConditionsAnalgesia, Pain, Postoperative
InterventionsPain Management (Other)
Datesstart 2022-07-17, primary completion 2023-05-09, completion 2023-05-09, first posted 2022-07-06, last updated 2023-07-21
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
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-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.

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+Detailed 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.

+Arms and interventions

ArmTypeInterventionsDescription
External Oblique Intercostal Block GroupExperimentalOther: Pain ManagementWhile patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening.
ControlActive comparatorOther: Pain ManagementPatients in the control group will not have any intervention concerning regional anesthesia.
  • Pain Management (Other): Regional anesthetic techniques for peri-operative pain management after surgery.

+Outcome measures

Primary outcomes

  • Postoperative opioid consumption [24 hours]: Contramal consumption in the first 24 hours after surgery

Secondary outcomes

  • NRS scores [At 1,3, 6, 12, 18, 24 hours]: NRS scores in the first 24 hours after surgery
  • Quality of recovery [24 hours]: QR15 scores
  • Nausea and vomiting [At 1,3, 6, 12, 18, 24 hours]: Nausea and vomiting scores in the first 24 hours

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

FacilityCityCountryStatus
Samsun UniversitySamsunTurkey (Türkiye)

+Investigators