- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582640
Comparison Between Erector Spinae Plane Block vs Transversus Abdominis Plane Block for Postoperative Analgesia in Cesarean Section
Erector Spinae Plane Block Versus Transversus Abdominis Plane Block For Postoperative Analgesia In Cesarean Section: Comparative Randomized Prospective Study
This study is a prospective randomized controlled trial designed to compare the effectiveness of the erector spinae plane (ESP) block versus the transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing cesarean section under spinal anesthesia. Sixty patients will be randomly allocated into two equal groups to receive either ESP or TAP block after surgery.
The primary outcome of the study is the assessment of postoperative pain using the Numeric Rating Scale (NRS) over the first 24 hours. Secondary outcomes include total morphine consumption, time to first request for rescue analgesia, patient satisfaction, incidence of complications, and hemodynamic stability.
All patients will receive standardized spinal anesthesia followed by the assigned block using a combination of bupivacaine and lidocaine under ultrasound guidance. Postoperatively, a multimodal analgesic regimen will be applied, including regular paracetamol and rescue analgesia with ketorolac or morphine based on pain scores.
The rationale of the study is based on the limitation of the TAP block in providing only somatic analgesia, whereas the ESP block may offer both somatic and visceral pain control due to its wider spread. Therefore, the study aims to determine whether ESP block provides superior postoperative analgesia and reduces opioid requirements compared to TAP block after cesarean delivery.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed ali Elyamany, resident
- Phone Number: 01061646235
- Email: aboelyamany@gmail.com
Study Locations
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Sohag, Egypt
- Sohag faculty of medicine
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Contact:
- mohamed elyamany, resident
- Phone Number: 01061646235
- Email: aboelyamany@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age from 18 to 40 years old.
- Pregnant women.
- Scheduled for lower-segment cesarean section.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Singleton pregnancy at ≥37 weeks' gestation.
Exclusion Criteria:
• Contraindications to regional blocks or local anesthetics.
- History of chronic analgesic use or opioid dependency.
- Coagulopathy or anticoagulant therapy.
- Local infection at the injection site.
- Allergy to study medications.
- Patient refusal.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: ESPB group
patients included in this group will receive the erector spinae plane block.
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For the ESP block, patients will be placed in the right lateral decubitus position, and the T9 transverse process will be identified using a high-frequency linear ultrasound probe positioned 2-3 cm lateral to the midline in a parasagittal orientation.
After skin sterilization, a 21-gauge echogenic block needle will be advanced in-plane cranio-caudally until contact with the transverse process is achieved.
Hydrodissection with sterile saline will be performed to confirm correct fascial plane placement beneath the erector spinae muscle.
A total of 20 mL local anesthetic mixture will be administered on each side, consisting of 10 mL bupivacaine 0.25%- and 10-mL lidocaine 0.5%, ensuring that the maximum safe dose is not exceeded.
Correct spread will be confirmed under ultrasound by observing separation of the fascial layers.
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Active Comparator: TAP group
patients included in this group will receive the transversus abdominis plane block.
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For the TAP block, patients will be placed supine, and the posterior approach will be used with the probe placed midway between the subcostal margin and the iliac crest in the anterior axillary line.
The fascial plane between the internal oblique and transversus abdominis muscles will be visualized until it tapers toward the quadratus lumborum.
A 21-gauge echogenic needle will be introduced in-plane from anterior to posterior, and hydrodissection with sterile saline will be performed to confirm the correct plane.
A total of 20 mL local anesthetic mixture will be administered per side, composed of 10 mL bupivacaine 0.25%- and 10-mL lidocaine 0.5%, with care taken to remain within safe dosage limits.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative pain scores assessment using the Numeric Rating Scale (NRS).
Time Frame: Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
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Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
Pain scores will be evaluated both at rest and during movement.Patients will be informed about Numerical Rating Scale (NRS) and asked to circle the number between 0 and 10, Zero means no pain and ten means the worst pain].
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Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total morphine consumption
Time Frame: the first 24 hours postoperatively.
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• Total morphine consumption in the first 24 hours postoperatively.
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the first 24 hours postoperatively.
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Time to first request for rescue analgesia.
Time Frame: during the first 24 postoperative hours.
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during the first 24 postoperative hours.
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Patient satisfaction scores
Time Frame: at 24 hours.
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Degree of patient satisfaction will be assessed on a 5-point likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied) (10).
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at 24 hours.
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Incidence of block-related complications
Time Frame: first 24 hours postoperatively.
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Adverse events: local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression or any other complication.
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first 24 hours postoperatively.
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Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-Med-26-3-10MS
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
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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