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Enrolling by invitation Phase 1

Dexmedetomidine Added to Bupivacaine for ESP Block in Children Undergoing Lower Abdominal Surgeries

NCT07023991 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 1
Started
2025-05-01
Last updated
2025-06-17

Condition(s) studied

Post-operative Pain

Investigational drug(s) / intervention(s)

Bupivacaine →Dexmedetomidine →

Bupivacaine: Bupivacaine will be used in an ESP block to provide postoperative analgesia.

Dexmedetomidine: Dexmedetomidine will be added to bupivacaine in the ESP block to evaluate its effect on duration of postoperative analgesia.

Study summary

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

Eligibility

Sex
ALL
Min age
1 Year
Max age
7 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Pediatric patients aging 1-7 years old of both sexes. 2. Patients scheduled for unilateral or bilateral lower abdominal surgeries. 3. American Society of Anesthesiologists (ASA) Physical Status Class I, II Exclusion Criteria: 1. Parents or legal guardian refusal of participation in the study. 2. Contraindication to regional anesthesia (including coagulopathy and local infection). 3. History or known allergy to local anesthetics. 4. Past history of any complications related to the block. (including hematoma and intravascular injection) 5. Spinal anomalies altered mental status, a history of developmental delay. 6. Additional surgical procedures at different surgical sites.

Primary outcome measure(s)

  • Duration of Postoperative Analgesia — Up to 24 hours after surgery
    Measurement of the time from recovery of anesthesia to the need of first given dose of rescue analgesia.

Trial sites (1)

FacilityCityRegionStatus
Ain Shams University Cairo Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07023991 on ClinicalTrials.gov ↗ ← All trials in Egypt