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

NCT07121764 | Completed Phase 4

• 1 other identifier: U1111-1326-5938
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia Repair; Orchiopexy; Hypospadias

Keywords

Bupivacaine; Dexmedetomidine; Caudal block; Pediatrics; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Analgesia Duration

  Duration of post-operative pain free time (hours): time from surgery to FLACC score ≥7 needing rescue analgesia

  From surgery to 24-hours post operatively

Other Outcomes (1)

• Analgesia Consumption

  From surgery to 24-hours post operatively

Study Arms (2)

Monotherapy

ACTIVE COMPARATOR

Bupivacaine alone

Drug: Bupivacaine %0.25 (isobaric)

Combination therapy

EXPERIMENTAL

Bupivacaine with Dexmedetomidine

Drug: Dexmedetomidine & Bupivacaine.

Interventions

Bupivacaine %0.25 (isobaric) DRUG

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

Monotherapy

Dexmedetomidine & Bupivacaine. DRUG

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

Combination therapy

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Allama Iqbal Teaching Hospital: lead

Study Sites (1)

Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

Related Publications (2)

• Saadawy I, Boker A, Elshahawy MA, Almazrooa A, Melibary S, Abdellatif AA, Afifi W. Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics. Acta Anaesthesiol Scand. 2009 Feb;53(2):251-6. doi: 10.1111/j.1399-6576.2008.01818.x. Epub 2008 Dec 6.

  PMID: 19076110 BACKGROUND

• Goyal V, Kubre J, Radhakrishnan K. Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children. Anesth Essays Res. 2016 May-Aug;10(2):227-32. doi: 10.4103/0259-1162.174468.

  PMID: 27212752 BACKGROUND

MeSH Terms

Conditions

Hypospadias

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Syed A Abbas Naqvi, FCPS

  Allama Iqbal Teaching Hospital Dera Ghazi Khan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 13, 2025
• Study Start: April 27, 2025
• Primary Completion: July 26, 2025
• Study Completion: July 26, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)