NCT00707824

Brief Summary

Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_4

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

June 1, 2000

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2008

Completed
Last Updated

July 8, 2008

Status Verified

February 1, 2006

Enrollment Period

5.5 years

First QC Date

June 29, 2008

Last Update Submit

July 7, 2008

Conditions

Cesarean Section

Keywords

pruritusepidural morphine

Outcome Measures

Primary Outcomes (1)

  • incidence and severity of pruritus

    24 hr

Secondary Outcomes (1)

  • visual analogue pain score

    24 hr

Study Arms (3)

1

PLACEBO COMPARATOR

1= placebo

Other: NSS

2

ACTIVE COMPARATOR

2=nalbuphine 5 mg

Drug: nalbuphine

3

ACTIVE COMPARATOR

3=nalbuphine 10 mg

Drug: nalbuphine

Interventions

nalbuphineDRUG

nalbuphine 5 mg epidural

Also known as: nubain
2
NSSOTHER

NSS

Also known as: nornal saline
1

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • full term parturient undergoing elective cesarean section
  • ASA 1-2

You may not qualify if:

  • drug or alcohol abuses
  • contraindication for regional anesthesia
  • received opioids within 12 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Pruritus

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Orawan Pongraweewan, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2008

First Posted

July 1, 2008

Study Start

June 1, 2000

Primary Completion

December 1, 2005

Study Completion

February 1, 2006

Last Updated

July 8, 2008

Record last verified: 2006-02

Locations

TH(1)