Nebulized Bupivacaine Analgesia for Cleft Palate Repair

Phase 3

Recruiting

• Conditions: Cleft Palate
• Interventions: Other: 0.9% saline; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04928352
• Lead Sponsor: Assiut University

Brief Summary

In this study we introduce a potent local anesthetic; bupivacaine 0.5% in two different doses by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.

Detailed Description

A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive; Nebulized Bupivacaine 0.50% 0.25 mg.kg-1 (Group B1) or Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 (Group B2) or same volume of saline placebo (Group C).

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study Start: 2021-06-14
• Study First Posted: 2021-06-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
• Elective cleft palate repair ± cleft lip surgery under general anesthesia .

Exclusion Criteria

• Coronary artery disease
• Hypertension
• Developmental delay
• Allergy to study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	0.9% saline	Same volume of nebulized saline placebo
Group B2	Bupivacaine Hydrochloride	Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Group B1	Bupivacaine Hydrochloride	Nebulized Bupivacaine 0.50% 0.25 mg.kg-1

Primary Outcome Measures

Name	Time	Method
the total postoperative consumption of rescue analgesics	24 hour after surgery	Patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were ≥3. The FLACC (Face, Legs, Activity, Cry, Consolability). We rate the child in each of the five measurement categories, add together, and document total pain score (0 - 10) where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain. The scale will be recorded on admission to PACU (baseline), and at 30 minutes, 1, 2, 3, 4, 5, 6, 12 and 24 hour postoperative.

Secondary Outcome Measures

Name	Time	Method
Postoperative FLACC score	24 hour postoperative	The FLACC (Face, Legs, Activity, Cry, Consolability) is a behavioural pain assessment scale for use in non-verbal or pre-verbal patients unable to self-report their level of pain.We rate the child in each of the five measurement categories, add together, and document total pain score (0 - 10) where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain. The scale will be recorded on admission to PACU (baseline), and at 30 minutes, 1, 2, 3, 4, 5, 6, 12 and 24 hour postoperative.
The time to first request for rescue analgesics	24 hour postoperative	Recording the first time when patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were ≥3.

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Assuit, Egypt