MedDataX Logo

Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

NCT ID: NCT00707824

Last Updated: 2008-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2006-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pruritus epidural morphine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

1= placebo

Group Type PLACEBO_COMPARATOR

NSS

Intervention Type OTHER

NSS

2

2=nalbuphine 5 mg

Group Type ACTIVE_COMPARATOR

nalbuphine

Intervention Type DRUG

nalbuphine 5 mg epidural

3

3=nalbuphine 10 mg

Group Type ACTIVE_COMPARATOR

nalbuphine

Intervention Type DRUG

nalbuphine 10 mg epidural

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nalbuphine

nalbuphine 5 mg epidural

Intervention Type DRUG

nalbuphine

nalbuphine 10 mg epidural

Intervention Type DRUG

NSS

NSS

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nubain nubaine nornal saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mahidol University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Orawan Pongraweewan, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

110/2000

Identifier Type: -

Identifier Source: org_study_id