Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05617976
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.5
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caudal Anesthesia	Procedure: caudal block	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children
• Actual Study Start Date: Oct 4, 2020
• Actual Primary Completion Date: Sep 20, 2021
• Actual Study Completion Date: Sep 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. duration of analgesia [24hours]

   Time to first analgesia request (TFAR)

Secondary Outcome Measures

1. analgesic consumption [24 hours]

   total dose of rescue analgesic

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 3 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT05617976
• Other Study ID Numbers: FMASU MS 120/2020
• First Posted: Nov 16, 2022
• Last Update Posted: Nov 16, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 16, 2022