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

Allama Iqbal Medical College

Status and phase: Completed; Phase 1

Conditions: Rescue Analgesia; Pain

Treatments: Drug: Bupivacain; Drug: Dexmedetomidine & Bupivacaine.

Study type: Interventional

Funder types: Other

Identifiers

NCT07140627

65

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Male

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Group A with 0.25% Bupivacaine only

Experimental group

Description:

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.

Treatment:

Drug: Bupivacain

Group B with 0.25% Bupivacaine and Dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine & Bupivacaine.