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Clinical Trials/NCT06712498
NCT06712498
Completed
Not Applicable

INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital1 site in 1 country64 target enrollmentNovember 26, 2024

Overview

Phase
Not Applicable
Intervention
External Oblique Intercostal Plane Block
Conditions
Laparoscopic Cholecystectomy
Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Enrollment
64
Locations
1
Primary Endpoint
Numeric Rating Scale
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. The purpose of our study is to compare parameters such as intraoperative hemodynamics, postoperative analgesic requirement, and patient satisfaction between patients undergoing External Oblique Intercostal Plane Block (EOIB) with those who did not receive EOIB, which has few studies conducted on it.

Registry
clinicaltrials.gov
Start Date
November 26, 2024
End Date
December 30, 2024
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mazlum Dursun

Anesthesiology and Reanimation spesialist

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients aged between 18-65
  • and with ASA1-2 were included.

Exclusion Criteria

  • Patients younger than 18 years of age and older than 65 years of age
  • Patients allergic to local anesthetics
  • Patients with opioid and alcohol addiction
  • Patients with perioperative signs of acute cholecystitis
  • Patients with contraindications for laparoscopic surgery
  • Cases with ASA III-IV were not included in the study.

Arms & Interventions

External oblique intercostal plan block group

After endotracheal intubation, a 22-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally).

Intervention: External Oblique Intercostal Plane Block

control group

No Intervention

Intervention: control group

Outcomes

Primary Outcomes

Numeric Rating Scale

Time Frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome

Visual Analogue Scale

Time Frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

The Visual Analogue Scale (VAS) is a subjective measure of pain. It consists of a 10cm line with two endpoints representing 'no pain' and 'worst pain imaginable'. Patients are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.

Secondary Outcomes

  • Riker Sedation Agitation Scale(Immediately after extubation)
  • Patient satisfaction score(at the 24th postoperative hour)
  • Postoperative vomiting and nausea(Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours)
  • Opioid use(Postoperative 24 hours)
  • Mean Arter Pressure(when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours)
  • Heart Rate(when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours)

Study Sites (1)

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