A Phase 4 interventional study of Bupivacaine %0.25 (isobaric) and Dexmedetomidine & Bupivacaine. in Hernia Repair, Orchiopexy and Hypospadias, sponsored by Allama Iqbal Teaching Hospital. Completed at 1 site in Pakistan. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Allama Iqbal Teaching Hospital · Phase 4, Interventional, and Treatment
This study is being done to find out which medicine combination provides better pain relief after surgery in children. Children who are having surgery below the belly button (called infra-umbilical surgery) will receive general anesthesia and a type of pain-blocking injection called a caudal block. This block helps reduce pain after surgery.
The study will compare two types of caudal injections:
One group will receive Bupivacaine alone, a commonly used local anesthetic.
The other group will receive Bupivacaine combined with Dexmedetomidine, a medicine that might help the pain relief last longer.
The main question the researchers want to answer is:
Does adding Dexmedetomidine to Bupivacaine increase the duration of pain relief after surgery in children?
Researchers will also look at:
How long it takes before the child needs the first dose of pain medicine after surgery
How much pain medicine is used in the first 24 hours
How long any movement problems (motor block) last
Whether there are any side effects
Each child will be randomly assigned (like flipping a coin) to one of the two groups. The caudal block will be done after the surgery is completed, while the child is still under anesthesia. The nurse assessing the child's pain will not know which medicine the child received.
Children will be monitored for pain using a standard scoring system (FLACC scale) every few hours after surgery. If the pain score is high (7 or more), the child will receive intravenous paracetamol. Researchers will record how long the pain relief lasts, when the first pain medicine is needed, and the total amount of pain medicine used in the first 24 hours.
The study aims to help doctors choose the most effective and safe method to reduce post-surgery pain in children.
131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
This study's enrollment of 60 is below the median of 68 across 102 interventional studies indexed under Hypospadias.
Browse Hypospadias studies →Allama Iqbal Teaching Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bupivacaine alone
Drug: Bupivacaine %0.25 (isobaric)
Bupivacaine with Dexmedetomidine
Drug: Dexmedetomidine & Bupivacaine.
1 ml/kg of 0.25% Bupivacaine will be used for caudal block.
1 ml/kg of 0.25% Bupivacaine PLUS 1 μg/kg Dexmedetomidine in 1 ml Normal Saline will be used for caudal block.
Analgesia Duration
Duration of post-operative pain free time (hours): time from surgery to FLACC score ≥7 needing rescue analgesia
Time frame: From surgery to 24-hours post operatively
Analgesia Consumption
Total amount (milligrams) of paracetamol consumed
Time frame: From surgery to 24-hours post operatively
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Allama Iqbal Teaching Hospital