Ain Shams University
Cairo, Egypt, 11865
NCT Number: NCT07023991
This study aims to evaluate the effect of adding dexmedetomidine to bupivacaine in erector spinae plane (ESP) blocks on the duration of postoperative analgesia in pediatric patients undergoing lower abdominal surgery. Effective postoperative pain control in children remains a clinical challenge, and regional anesthesia techniques such as the ESP block have shown promise in improving outcomes.
In this randomized, double-blind clinical trial, pediatric patients scheduled for elective lower abdominal surgeries will be assigned to receive either bupivacaine alone or bupivacaine combined with dexmedetomidine as part of an ultrasound-guided ESP block. The primary outcome is the duration of postoperative analgesia, defined as the time from the block until the first request for rescue analgesia. Secondary outcomes include total analgesic consumption and postoperative pain scores
Interested in participating?
Request Info1 year–7 year
All sexes
Interventional
Phase 1
Cairo, Egypt, 11865
In group A: US guided ESPB will be performed with aseptic precautions using a (6- 19) MHz linear probe in a sterile cover with sterile jelly (GE LOGIQ 5, USA).
In group B: This group will receive ESPB using Bupivacaine 0.25% (with a maximum dose 2 mg/kg) alone 15 min before skin incision with the same protocol and precautions.
Postoperative setting:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bupivacaine will be used in an ESP block to provide postoperative analgesia.
Other names: Marcaine
Dexmedetomidine will be added to bupivacaine in the ESP block to evaluate its effect on duration of postoperative analgesia.
Other names: Precedex
Time frame: Up to 24 hours after surgery
Measurement of the time from recovery of anesthesia to the need of first given dose of rescue analgesia.
Time frame: At 1, 2, 4, 6, 12, and 24 hours after surgery
Time frame: During the operation from the induction of anesthesia until the recovery.
Total intraoperative fentanyl consumption in micrograms
Time frame: Within 24 hours postoperatively
The total amount (in milligrams) of rescue analgesics administered to the patient within the first 24 hours after surgery.
Time frame: Within 24 hours postoperatively
The occurrence of adverse effects such as sedation, nausea, vomiting, bradycardia, or hypotension within 24 hours after surgery.
Ain Shams University
Other
Effect of Adding Dexmedetomidine to Bupivacaine in US- Guided Erector Spinae Plane Block for Post-operative Pain Management in Pediatric Patients Undergoing Lower Abdominal Surgeries
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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