Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Ain Shams University

Status: Completed

Conditions: Caudal Anesthesia

Treatments: Procedure: caudal block

Study type: Interventional

Funder types: Other

Identifiers

NCT05617976

FMASU MS 120/2020

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Group L (levobupivacaine only group)

Active Comparator group

Description:

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.

Treatment:

Procedure: caudal block

Group L+N(levobupivacaine plus nalbuphen group)

Active Comparator group

Description:

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.

Treatment:

Procedure: caudal block