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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-27

Study Completion Date

2025-07-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Hernia Repair Orchiopexy Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Monotherapy

Bupivacaine alone

Group Type ACTIVE_COMPARATOR

Bupivacaine %0.25 (isobaric)

Intervention Type DRUG

1 ml/kg of 0.25% Bupivacaine will be used for caudal block.

Combination therapy

Bupivacaine with Dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine & Bupivacaine.

Intervention Type DRUG

1 ml/kg of 0.25% Bupivacaine PLUS 1 μg/kg Dexmedetomidine in 1 ml Normal Saline will be used for caudal block.

Interventions

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Bupivacaine %0.25 (isobaric)

1 ml/kg of 0.25% Bupivacaine will be used for caudal block.

Intervention Type DRUG

Dexmedetomidine & Bupivacaine.

1 ml/kg of 0.25% Bupivacaine PLUS 1 μg/kg Dexmedetomidine in 1 ml Normal Saline will be used for caudal block.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No