Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Not Applicable

Completed

• Conditions: Caudal Anesthesia
• Interventions: Procedure: caudal block

• Registration Number: NCT05617976
• Lead Sponsor: Ain Shams University

Brief Summary

Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many opioids can be added in caudal analgesia. This prospective randomized double blind study was done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-04
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Study First Submitted: 2022-02-23
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-16
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• ASA I, II.
• Age 1-3 years.
• Patients scheduled for hypospadias repair surgeries.

Exclusion Criteria

• ASA III, IV.
• Signs of infection at site of injection.
• Known coagulopathy disorder.
• Mental and / or developmental retardation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L (levobupivacaine only group)	caudal block	Caudal block was done in this group using levobupivacaine 0.25% with the dose of 1 ml /kg plus one ml normal saline after induction of general anesthesia.
Group L+N(levobupivacaine plus nalbuphen group)	caudal block	Caudal block was done in this group using levobupivacaine 0.25% with the dose of 1 ml /kg and nalbuphine 0.1 mg /kg in one ml normal saline after induction of general anesthesia.

Primary Outcome Measures

Name	Time	Method
duration of analgesia	24hours	Time to first analgesia request (TFAR)
Quality of Postoperative analgesia	24 hours	Face legs activity cry consolablity score (FLACC) (0-10) Score: 0, no pain; 1-3, mild pain; 4-7, moderate pain; 8-10, severe pain

Secondary Outcome Measures

Name	Time	Method
analgesic consumption	24 hours	total dose of rescue analgesic

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt