- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06514417
External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries (EOINB)
Efficacy of Ultrasound - Guided External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shibin Elkom
-
Cairo, Shibin Elkom, Egypt
- Menoufia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Selected patients will be more than 21 years old with ASA physical status I & II scheduled for upper abdominal surgeries
Exclusion Criteria:
Uncooperative patients.
- Patients who have allergy to any of the used drugs.
- Patients who are on opioids.
- Known abuse of alcohol or medication.
- Local infection at the site of injection or systemic infection.
- Pregnancy
- Patients with coagulation disorders or on anticoagulation therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: external oblique intercostal block
receive US-guided external oblique intercostal block after induction
|
After induction of general anesthesia, external oblique intercostal block will be performed (8) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz). the patient will be positioned supine, and a linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib. 20 ml of bupivacaine 0.25% will be injected between the plane of the external oblique and the intercostal muscles. The drug will be injected after a negative aspiration. The contralateral side block will be performed in a same manner. |
|
No Intervention: No block
receive postoperative morphine on patient request
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue pain scale .
Time Frame: 24 hours
|
postoperative pain that evaluated by visual analogue pain scale(a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total perioperative analgesics requirements
Time Frame: 24 hours
|
Milligram
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7/2023ANET12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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