- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05179928
Erector Spinae Plane Block Versus Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery
Is Erector Spinae Plane Block More Effective Than Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery in Adult Patients
Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes.
Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses.
ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them.
Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed M Shaat, MD
- Phone Number: 00201223482709
- Email: ahmedshaat99@gmail.com
Study Locations
-
-
El-Beheira
-
Damanhūr, El-Beheira, Egypt
- Recruiting
- Damanhour Teaching Hospital
-
Contact:
- Ahmed M Shaat, MD
- Phone Number: 00201223482709
- Email: ahmedshaat99@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 21 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
- Pregnant women
- Allergy to study drugs
- Chronic pain
- Coagulation abnormalities or on anticoagulants
- Severe hepatic or kidney disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group E (n=30)
Erector Spinae Plane Block
|
Postoperative Bilateral Ultrasound-guided ESPB
|
|
Active Comparator: Group R (n=30)
Rectus Sheath Block
|
Postoperative Bilateral Ultrasound-guided RSB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
Time Frame: 24 hours after block performance
|
The time interval between the block performance and the first request of postoperative analgesia
|
24 hours after block performance
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
Time Frame: 24 hours after block performance
|
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (30 minutes, 1h, 6h, 12h, 18h, 24h) after block performance
|
24 hours after block performance
|
|
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
Time Frame: 24 hours after block performance
|
The total dose of the rescue analgesic consumed in the first 24 hours after block performance
|
24 hours after block performance
|
|
Number of participants and Rate of Postoperative Complications
Time Frame: 24 hours after block performance
|
Number of participants and Rate of: Nausea, Vomiting, Hematoma formation, Bowel perforation, and Pneumothorax
|
24 hours after block performance
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DTH: 21004
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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