- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07366138
Ultrasound-Guided External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block For Perioperative Analgesia in Laparoscopic Sleeve Gastrectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain management is a critical aspect of enhanced recovery after surgery (ERAS) protocols, particularly in laparoscopic bariatric procedures such as sleeve gastrectomy.
Among the ultrasound-guided abdominal wall blocks, the transversus abdominis plane (TAP) block and its subcostal variant have demonstrated efficacy for upper abdominal surgeries. The subcostal TAP block provides analgesia for the T6-T9 dermatomes, covering incisions in upper abdominal procedures like laparoscopic cholecystectomy and bariatric surgery.
The external oblique intercostal plane (EOIP) block is a relatively new fascial plane block that targets the intercostal nerves lying between the external oblique and intercostal muscles.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed A Ali, MBBCH
- Phone Number: 00201067850909
- Email: macisosevo@gmail.com
Study Locations
-
-
Benha
-
Banhā, Benha, Egypt, 13518
- Recruiting
- Benha University
-
Contact:
- Ahmed A Ali, MBBCH
- Phone Number: 00201067850909
- Email: macisosevo@gmail.com
-
Sub-Investigator:
- El sayed M Abd Elazeem, MD
-
Sub-Investigator:
- Fatma A Abd Elfataah, MD
-
Sub-Investigator:
- Zienab M Abd Elwahab, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 18 to 65 years.
- Both genders.
- American Society of Anesthesiologists (ASA) class I or II
- Body mass index (BMI) between 30-50 kg/m².
- Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.
- Written informed consent from patients or surrogate decision makers.
Exclusion Criteria:
- Patient refusal.
- Allergy to local anesthetics.
- Coagulation disorders or anticoagulant therapy.
- Local infection or scar at the injection site.
- Severe hepatic or renal dysfunction.
- Chronic opioid use or psychiatric illness interfering with pain assessment.
- Conversion to open surgery or intraoperative complications requiring re-exploration.
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: EOIP Group (Group A )
Patients will receive an ultrasound-guided bilateral external oblique intercostal plane (EOIP) block using 20 mL of 0.25% bupivacaine in each side after induction of anesthesia and prior to surgical incision.
|
Patients will receive an ultrasound-guided bilateral external oblique intercostal plane (EOIP) block using 20 mL of 0.25% bupivacaine in each side after induction of anesthesia and prior to surgical incision.
|
|
Experimental: Subcostal TAP Group (Group T)
Patients will receive a bilateral subcostal transversus abdominis plane (TAP) block using 20 mL of 0.25% bupivacaine in each side, under ultrasound guidance and identical conditions.
|
Patients will receive a bilateral subcostal transversus abdominis plane (TAP) block using 20 mL of 0.25% bupivacaine in each side, under ultrasound guidance and identical conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
Patient-controlled analgesia (PCA) using intravenous morphine (1 mg bolus, 10-minute lockout) will be available for rescue analgesia when visual analogue score ( VAS ) > 3.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
|
24 hours postoperatively
|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with the visual analogue score (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be recorded at 0, 2, 6, 12, and 24 hours postoperatively (at rest and cough). |
24 hours postoperatively
|
|
Heart rate
Time Frame: Till the end of surgery (Up to two hours)
|
Heart rate will be recorded intraoperatively and postoperatively
|
Till the end of surgery (Up to two hours)
|
|
Mean arterial blood pressure
Time Frame: Till the end of surgery (Up to two hours)
|
Mean arterial blood pressure will be recorded intraoperatively and postoperatively
|
Till the end of surgery (Up to two hours)
|
|
Incidence of postoperative nausea and vomiting
Time Frame: 24 hours postoperatively
|
Incidence of postoperative nausea and vomiting (PONV) will be recorded.
|
24 hours postoperatively
|
|
Block-related complications
Time Frame: 24 hours postoperatively
|
Block-related complications such as pleural puncture, local anesthetic toxicity, and hematoma will be recorded.
|
24 hours postoperatively
|
|
Degree of patient satisfaction
Time Frame: 24 hours postoperatively
|
Patient satisfaction will be assessed using a 5-point Likert scale at 24 hours (1 = very dissatisfied , 2 = dissatisfied, 3 =mild, 4= moderate satisfaction, 5 = very satisfied ).
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- MS.28.12.2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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