NCT02618876

Brief Summary

Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair. 2 groups, 30 patients each

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable postoperative-pain

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

November 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

4.1 years

First QC Date

November 25, 2015

Last Update Submit

April 6, 2020

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale

    During 24 h in the postoperative period

Secondary Outcomes (1)

  • Cortisol level

    6 hours

Study Arms (2)

Nalbuphine group

ACTIVE COMPARATOR

30 children will be given Caudal Bupivacaine plus Nalbuphine.

Drug: Nalbuphine plus Bupivacaine

Control group

OTHER

30 children will be given Caudal Bupivacaine.

Drug: Bupivacaine

Interventions

Nalbuphine plus BupivacaineDRUG

Addition of caudal Nalbuphine to the standard Bupivacaine

Nalbuphine group
BupivacaineDRUG

Caudal Bupivacaine is the standard of care will be considered as a control

Control group

Eligibility Criteria

Age2 Years - 10 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children undergoing elective Hypospadias repair
  • with American Society of Anesthesiologists (ASA) physical status I
  • age 2-10 years

You may not qualify if:

  • Coagulation disorder
  • allergy to study medications
  • major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

NalbuphineBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 2, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

EG(1)