COMPARISON OF BUPIVACAINE WITH AND WITHOUT DEXMEDETOMIDINE IN CAUDAL BLOCK AMONG CHILDREN UNDERGOING INGUINAL HERNIOTOMY

NCT07140627 | Completed Phase 1

• 1 other identifier: 65
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A random controlled trial, was held at Jinnah Hospital in Lahore, consisting of 60 male pediatrics (6 months to 12 years), who were undergoing unilateral inguinal herniotomy or hydrocele repair. Patients were randomly allocated in two groups: Group A alone received 1 mL/kg 0.25% bupivacaine, while Group B received the same dose with 1 μg/kg dexmedetomidine. The pain score was evaluated by Wong-Beker Face Scale postoperatively every two hours, rescue analgesia (intravenous paracetamol 10 mg/kg) when the pain score reached ≥4

Conditions

Pain; Rescue Analgesia

Keywords

Bupivacaine; Dexmedetomidine; Inguinal herniotomy; Rescue Analgesia

Outcome Measures

Primary Outcomes (1)

• Post operative Pain

  In both groups the attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data.

  2 hourly assessment for 8 hours on basis of pain score

Study Arms (2)

Group A with 0.25% Bupivacaine only

EXPERIMENTAL

After ethical approval, patients who met inclusion criteria were enrolled after obtaining written consent from their parents. Using computer-related random numbers, patients were allocated in two groups of 30: Group A Included 30 participants and received Bupivacaine alone. A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. The attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data.

Drug: Bupivacain

Group B with 0.25% Bupivacaine and Dexmedetomidine

EXPERIMENTAL

After ethical approval, patients who met inclusion criteria were enrolled after obtaining written consent from their parents. Using computer-related random numbers, patients were allocated in two groups of 30: Group B Included 30 participants and received Bupivacaine alone. A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. The attending physician recorded postoperative pain every two hours using the Wong-Baker Faces Pain Scale. Intravenous Paracetamol (10 mg/kg/dose) was given as rescue analgesia if the patient reported a pain score of ≥4, and the duration of the administration was recorded. Structured proforma were used to record all pertinent data.

Drug: Dexmedetomidine & Bupivacaine.

Interventions

Bupivacain DRUG

A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. 30 participants had received 1 mL/kg 0.25% bupivacaine. Post operative pain was assessed.

Group A with 0.25% Bupivacaine only

Dexmedetomidine & Bupivacaine. DRUG

A 22G cannula was used to perform a caudal block in the left lateral position under sterile conditions following the induction of anesthesia and before the surgery. 30 participants were included and administered 1 mL/kg 0.25% bupivacaine and 1 μg/kg dexmedetomidine. Post operative pain was assessed.

Group B with 0.25% Bupivacaine and Dexmedetomidine

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male children who were undergoing elective unilateral inguinal herniotomy or hydrocele surgery

You may not qualify if:

• Patients were excluded if they were already on analgesic (according to medical records)
• Obstructed inguinal hernias or bilateral hernias (confirmed through ultrasound)

Sponsors & Collaborators

• Allama Iqbal Medical College: lead

Study Sites (1)

Allama Iqbal Medical College/ Jinnah Hospital Lahore

Lahore, Punjab Province, 54550, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr Muhammad Umer Iqbal Butt, MBBS FCPS

  Allama Iqbal Medical College/Jinnah Hospital Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)