- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07692659
Ultrasound-Guided Parasternal/Rectus Sheath Block vs Erector Spinae Plane Block for Pain Control in Cardiac Surgery
Comparison of Ultrasound Guided Bilateral Parasternal Block With Bilateral Rectus Sheath Block Versus Ultrasound Guided Bilateral Erector Spinae Plane Block in Controlling Intra and Post-operative Pain After Cardiac Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Optimal anesthesia in cardiac surgery requires careful management to avoid sympathetic stimulation, with analgesia being central to patient safety and recovery. Traditionally, high-dose opioids were used, but this approach delays extubation, conflicting with fast-track protocols that emphasize early extubation. Consequently, opioid-free analgesia has gained importance, employing regional techniques such as neuraxial, paravertebral, and fascial plane blocks.
Thoracic epidural analgesia (TEA) offers effective pain control and reduces perioperative cardiovascular and respiratory complications. However, its use in anticoagulated patients raises concern for epidural hematoma. Alternatives like paravertebral and fascial plane blocks provide comparable analgesia with lower risk. The erector spinae plane block (ESPB) reduces analgesic requirements, though deep blocks still pose bleeding risks.
Superficial plane blocks are therefore clinically valuable. The parasternal intercostal block-targeting anterior cutaneous branches of intercostal nerves-has emerged as a safe option for patients undergoing median sternotomy while on anticoagulant or antiplatelet therapy. Additionally, bilateral rectus sheath block can reduce chest tube insertion pain after cardiac surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Walaa Y Elsabeeny, MD
- Phone Number: 01007798466
- Email: walaa.elsabeeny@nci.cu.edu.eg
Study Contact Backup
- Name: Mostafa A Ibrahim, MD
- Phone Number: +966541227090
- Email: MAbIbrahim@sghgroup.net
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both sexes,
- ASA III-IV patients
- body mass index between 20- 35 kg/m2
- adult patients above 18 years old will be included in the study
Exclusion Criteria:
- Patients with global hypokinesia
- ejection fraction < 40%
- low platelet count
- coagulation impairment
- deformity in the vertebral column
- severe renal and hepatic impairment
- any known allergy to the drugs used
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: Parasternal/ Rectus sheath
Patients will receive Parasternal and rectus sheath blocks; with injection of 10 ml bupivacaine 0.25% in each side after confirmation of needle position.
Both parasternal and rectus heath blocks will be performed bilaterally
|
the parasternal block will be performed parasternally at the level of fifth rib to the plane between the pectoralis major and the internal intercostal muscle.
The rectus sheath block will be performed through injection in the plane posterior to the rectus abdominis muscle and anterior to the posterior rectus sheath
|
|
Experimental: Erector Spinae Plane Block
The patients will receive a bilateral ESPB with an injection of 20 ml of bupivacaine 0.25%.
|
injection above the transverse process
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating score
Time Frame: 24 hours
|
postoperative pain scores using Numerical Rating Scale (NRS)
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative opioid consumption
Time Frame: 24 hours
|
opioid consumption in the first 24 hours postoperatively
|
24 hours
|
|
extubation time
Time Frame: immediate postoperative
|
time to extubate
|
immediate postoperative
|
|
first time to request analgesia
Time Frame: 24 hours
|
first time to request opioid analgesia
|
24 hours
|
|
peri-operative hemodynamics
Time Frame: intraoperative and 24 hours
|
incidence of hypotension, hypertension, tachycardia and bradycardia
|
intraoperative and 24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Walaa Y Elsabeeny, MD, A Professor of Anesthesia, Critical Care and Pain Management, National Cancer Institute, Cairo University
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
- ECC-2025-64
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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