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Clinical Trials/NCT05617976
NCT05617976CompletedNot Applicable

Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Ain Shams University1 site in 1 country64 target enrollmentStarted: October 4, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
1
Primary Endpoint
duration of analgesia

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
1 Year to 3 Years (Child)
Sex
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.

Outcomes

Primary Outcomes

duration of analgesia

Time Frame: 24hours

Time to first analgesia request (TFAR)

Quality of Postoperative analgesia

Time Frame: 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 Outcomes

  • analgesic consumption(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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