- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06712498
INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK IN PATIENTS UNDERGOING LAPARASCOPIC CHOLESYSTECTOMY OPERATION
November 18, 2025 updated by: Mazlum Dursun, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
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
Status
Completed
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- mazlum
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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