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

NCT ID: NCT07140627

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A with 0.25% Bupivacaine only

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.

Group Type: EXPERIMENTAL

Bupivacain

Intervention Type: 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 B with 0.25% Bupivacaine and Dexmedetomidine

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.

Group Type: EXPERIMENTAL

Dexmedetomidine & Bupivacaine.

Intervention Type: 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.

Interventions

Bupivacain

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.

Intervention Type: DRUG

Dexmedetomidine & Bupivacaine.

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allama Iqbal Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Muhammad Umer Iqbal Butt, MBBS FCPS

Role: PRINCIPAL_INVESTIGATOR

Allama Iqbal Medical College/Jinnah Hospital Lahore

Locations

Allama Iqbal Medical College/ Jinnah Hospital Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

65

Identifier Type: -

Identifier Source: org_study_id