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Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

Primary Purpose

Cesarean Section

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

nalbuphine

NSS

About this trial

This is an interventional prevention trial for Cesarean Section focused on measuring pruritus, epidural morphine

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

full term parturient undergoing elective cesarean section
ASA 1-2

Exclusion Criteria:

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

Sites / Locations

Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

1= placebo

2=nalbuphine 5 mg

3=nalbuphine 10 mg

Outcomes

Primary Outcome Measures

incidence and severity of pruritus

Secondary Outcome Measures

visual analogue pain score

Full Information

NCT ID

NCT00707824

First Posted

June 29, 2008

Last Updated

July 7, 2008

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00707824

Brief Title

Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

Official Title

Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2006

Overall Recruitment Status

Completed

Study Start Date

June 2000 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

182 parturients,ASA 1-2 undergoing cesarean section under epidural block were enrolled in the study. After obtaining informed consent,all received epidural anesthesia using 2% lidocaine with epinephrine 1:200000 via epidural cathetes at L2-3 or L3-4 in a volume suffient to achieve a T4 sensory level bilaterally. After the umbilical cord was clamped,patients were assigned randomly to three groups.The placebo group,N-5 group,and N-10 group received 4 ml epidural solution containing morphine 4 mg plus either saline, nalbuphine 5 mg, and nalbuphine 10 mg respectively.At the post anesthetic care unit, intravenous pethidine PCA were administered for inadequate pain control. Outcome measures : Incidence and severity of postoperative pruritus Quality of pain control Side effects of epidural morphine and nalbuphine such as respiratory depression,sedation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cesarean Section

Keywords

pruritus, epidural morphine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

1= placebo

Arm Title

Arm Type

Active Comparator

Arm Description

2=nalbuphine 5 mg

Arm Title

Arm Type

Active Comparator

Arm Description

3=nalbuphine 10 mg

Intervention Type

Drug

Intervention Name(s)

nalbuphine

Other Intervention Name(s)

nubain

Intervention Description

nalbuphine 5 mg epidural

Intervention Type

Drug

Intervention Name(s)

nalbuphine

Other Intervention Name(s)

nubaine

Intervention Description

nalbuphine 10 mg epidural

Intervention Type

Other

Intervention Name(s)

NSS

Other Intervention Name(s)

nornal saline

Intervention Description

NSS

Primary Outcome Measure Information:

Title

incidence and severity of pruritus

Time Frame

24 hr

Secondary Outcome Measure Information:

Title

visual analogue pain score

Time Frame

24 hr

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: full term parturient undergoing elective cesarean section ASA 1-2 Exclusion Criteria: drug or alcohol abuses contraindication for regional anesthesia received opioids within 12 hours

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orawan Pongraweewan, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mahidol University

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

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Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

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