Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Caudal Anesthesia Clinical Trial

Official title:

Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05617976
• Other study ID #: FMASU MS 120/2020
• Status: Completed
• Phase: N/A
• Start date: October 4, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: November 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caudal Anesthesia

Intervention

Procedure:
• caudal block
caudal block

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	duration of analgesia	Time to first analgesia request (TFAR)	24hours
Secondary	analgesic consumption	total dose of rescue analgesic	24 hours