Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

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.

Study Overview

• Status: Completed
• Conditions: Caudal Anesthesia
• Intervention / Treatment: Procedure: caudal block

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group L (levobupivacaine only group); 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.	Procedure: caudal block; caudal block
Active Comparator: Group L+N(levobupivacaine plus nalbuphen group); 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.	Procedure: caudal block; caudal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Postoperative analgesia	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	24 hours
duration of analgesia	Time to first analgesia request (TFAR)	24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesic consumption	total dose of rescue analgesic	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2020
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MS 120/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No