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OpenTrials
Completed

NCT Number: NCT05617976

Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

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.

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Key information

Conditions

Caudal Anesthesia

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caudal block

Procedure

caudal block

Primary outcomes

  1. 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

  2. duration of analgesia

    Time frame: 24hours

    Time to first analgesia request (TFAR)

Secondary outcomes

  1. analgesic consumption

    Time frame: 24 hours

    total dose of rescue analgesic

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2022
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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