Skip to content

Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05617976
Enrollment
64
Registered
2022-11-16
Start date
2020-10-04
Completion date
2021-09-20
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caudal Anesthesia

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.

Interventions

PROCEDUREcaudal block

caudal block

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 3 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of Postoperative analgesia24 hoursFace legs activity cry consolablity score (FLACC) (0-10) Score: 0, no pain; 1-3, mild pain; 4-7, moderate pain; 8-10, severe pain
duration of analgesia24hoursTime to first analgesia request (TFAR)

Secondary

MeasureTime frameDescription
analgesic consumption24 hourstotal dose of rescue analgesic

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026