- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547280
Comparison of the Effects of External Oblique Intercostal Plane Block and Subcostal Transversus Plane Block Methods With Ultrasound Guidance on Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy Operations
Study Overview
Status
Conditions
Detailed Description
Obesity is a global health problem currently treated with diet, pharmacotherapy, and bariatric surgery. Laparoscopic sleeve gastrectomy (LSG) is a common bariatric procedure that often results in moderate to severe postoperative pain. Adequate pain control after LSG is crucial for early mobilization and prevention of complications . As a relatively novel technique, the external oblique intercostal block (EOIB) provides analgesia for anterolateral upper abdominal surgery by blocking both the lateral and anterior cutaneous branches of the intercostal nerves between T6-7 and T10-11 . The subcostal transversus abdominis plane (s-TAP) block provides sensory blockade over nearly the entire anterior abdominal wall between T6 and T9. Therefore, it can be considered as part of multimodal analgesia for both laparotomy and laparoscopic abdominal surgical procedures.
The primary aim of this study was to investigate the effects of the external oblique intercostal block (EOIB) and the subcostal transversus abdominis plane (s-TAP) block on postoperative pain scores and opioid consumption in patients undergoing laparoscopic sleeve gastrectomy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MELİKE BOSTANCI ERKMEN, MD
- Phone Number: +905355708530
- Email: mlkbstnci@gmail.com
Study Contact Backup
- Name: Tolga Karaçay, MD
- Phone Number: +905458718351
- Email: tkaracay35@gmail.com
Study Locations
-
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Şanlıurfa
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Sanliurfa, Şanlıurfa, Turkey (Türkiye), 63200
- Sanliurfa Education and Research Hospital
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Contact:
- Sanliurfa Education and Research Hospital bostancı erkmen, MD
- Phone Number: +9005355708530
- Email: mlkbstnci@gmail.com
-
Contact:
- melike bostancı erkmen, MD
- Phone Number: +9005355708530
- Email: mlkbstnci@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged between 18 and 65 years
- Patients classified as American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria:
- Patients younger than 18 years or older than 65 years
- Inability to cooperate or comply with study procedures
- Liver and kidney failure
- American Society of Anesthesiologists (ASA) IV-V patient
- External oblique intercostal block(EOİB) and the Subcostal Transversus Abdominis Plane block(s-TAB) are contraindicated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: External Oblique Intercostal Block
patient receive block that External Oblique Intercostal Blcok
|
Ultrasound-guided external oblique intercostal plane block will be performed at the T6 level using 20 ml of 0.25% bupivacaine at the Immediately after intubation
|
|
Experimental: Subcostal Transversus Abdominis Plane Block (s-TAP)
Patient receive that OSTAP
|
Ultrasound-guided OSTAP block will be performed using 20 ml of 0.25% bupivacaine immediately after intubation.
|
|
Experimental: Local anesthetic infiltration
Surgeon implement local anesthetic to port site
|
Port-site local anesthetic infiltration will be performed with bupivacain after intubation by surgeon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Acute Pain Scores
Time Frame: postoperative T1: 0. hours, T2:4.hours,T3:12.hours,T4: 24.hours
|
Postoperative acute pain scores assingment with Visual Analog Scores
|
postoperative T1: 0. hours, T2:4.hours,T3:12.hours,T4: 24.hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Consumption
Time Frame: POSTOPERATİVE T1:0 HOURS T2:4. HOURS T3:12.HOURS T4:24.HOURS
|
We plan to investigate the effects of the external oblique intercostal block and the subcostal transversus abdominis plane block onopioid consumption in patients undergoing laparoscopic sleeve gastrectomy after surgery.
|
POSTOPERATİVE T1:0 HOURS T2:4. HOURS T3:12.HOURS T4:24.HOURS
|
|
PATIENT SATISFACTION (Likert Scale) Not satisfied at all 1 Slightly satisfied 2 Moderately satisfied3 Satisfied4 Excellent5 SURGEON SATISFACTION (Likert Scale) Not satisfied at all 1 Slightly satisfied 2 Moderately satisfied3 Satisfied4 Excellent5
Time Frame: Postoperative 24.hours
|
Secondary outcomes will include patient- and surgeon-based Likert scale assessments.
|
Postoperative 24.hours
|
|
Postoperative Nause and Vomiting
Time Frame: Postoperative first 24.hours
|
Postoperative first 24.hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Melike Bostancı Erkmen, M.D., Sanliurfa Education and Research Hospital
- Principal Investigator: Tolga Karaçay, M.D., Sanliurfa Education and Research Hospital
- Principal Investigator: Servet Sürmeli, M.D., Sanliurfa Education and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SanliurfaERH-ANESTEZİ-MBE-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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