NCT05617976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

February 23, 2022

Last Update Submit

November 8, 2022

Conditions

Caudal Anesthesia

Outcome Measures

Primary Outcomes (2)

  • 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

  • duration of analgesia

    Time to first analgesia request (TFAR)

    24hours

Secondary Outcomes (1)

  • analgesic consumption

    24 hours

Study Arms (2)

Group L (levobupivacaine only group)

ACTIVE COMPARATOR

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.

Procedure: caudal block

Group L+N(levobupivacaine plus nalbuphen group)

ACTIVE COMPARATOR

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.

Procedure: caudal block

Interventions

caudal blockPROCEDURE

caudal block

Group L (levobupivacaine only group)Group L+N(levobupivacaine plus nalbuphen group)

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I, II.
  • Age 1-3 years.
  • Patients scheduled for hypospadias repair surgeries.

You may not qualify if:

  • ASA III, IV.
  • Signs of infection at site of injection.
  • Known coagulopathy disorder.
  • Mental and / or developmental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

November 16, 2022

Study Start

October 4, 2020

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations

EG(1)