INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK IN PATIENTS UNDERGOING LAPARASCOPIC CHOLESYSTECTOMY OPERATION

Not Applicable

Recruiting

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Procedure: External Oblique Intercostal Plane Block; Drug: control group

• Registration Number: NCT06712498
• Lead Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-26
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2024-12-26
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External oblique intercostal plan block group	External Oblique Intercostal Plane Block	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).
control group	control group	No Intervention

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	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	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 Outcome Measures

Name	Time	Method
Riker Sedation Agitation Scale	Immediately after extubation	7 Dangerous Agitation ... 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.
Patient satisfaction score	at the 24th postoperative hour	Patients' satisfaction with the quality of pain management will be evaluated on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = highly dissatisfied; 3 = medium; 4 = very satisfactory; 5 = very satisfactory
Postoperative vomiting and nausea	Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours	Postoperative vomiting and nausea: yes or no
Opioid use	Postoperative 24 hours	Tramadol use
Mean Arter Pressure	when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours	mm/hg
Heart Rate	when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours	beats/minute

Trial Locations

Locations (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital; 🇹🇷 Diyarbakır, Kayapınar, Turkey