Postoperative Pain Relief in Children: Comparing Caudal Bupivacaine Alone Versus Bupivacaine With Dexmedetomidine for Infra-Umbilical Surgeries Under General Anesthesia

Not Applicable

Completed

• Conditions: Hernia Repair; Orchiopexy; Hypospadias
• Interventions: Drug: Bupivacaine %0.25 (isobaric); Drug: Dexmedetomidine & Bupivacaine.

• Registration Number: NCT07121764
• Lead Sponsor: Allama Iqbal Teaching Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-27
• Primary Completion: 2025-07-26
• Study Completion: 2025-07-26
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Elective infra-umbilical Surgeries
• ASA Status I and II

Exclusion Criteria

• Chronic systemic illness (cardiovascular, pulmonary or renal disease, hepatic impairment)
• Allergy to local anesthetics
• Coagulation disorder
• Local skin infection
• Neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy	Bupivacaine %0.25 (isobaric)	Bupivacaine alone
Combination therapy	Dexmedetomidine & Bupivacaine.	Bupivacaine with Dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Analgesia Duration	From surgery to 24-hours post operatively	Duration of post-operative pain free time (hours): time from surgery to FLACC score ≥7 needing rescue analgesia

Trial Locations

Locations (1)

Allama Iqbal Teaching Hospital; 🇵🇰 Dera Ghazi Khan, Punjab, Pakistan