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

INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kayapınar
      • Diyarbakır, Kayapınar, Turkey (Türkiye), 21070
        • Health Sciences University Gazi Yaşargil Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

operating

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
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
No Intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
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.
Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Riker Sedation Agitation Scale
Time Frame: 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.
Immediately after extubation
Patient satisfaction score
Time Frame: 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
at the 24th postoperative hour
Postoperative vomiting and nausea
Time Frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
Postoperative vomiting and nausea: yes or no
Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
Opioid use
Time Frame: Postoperative 24 hours
Tramadol use
Postoperative 24 hours
Mean Arter Pressure
Time Frame: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
mm/hg
when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
Heart Rate
Time Frame: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
beats/minute
when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2024

Primary Completion (Actual)

December 26, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

December 2, 2024

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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