Interaction Between Nalbuphine and Morphine in PCA

November 22, 2005 updated by: National Taiwan University Hospital

Interaction Between Nalbuphine and Morphine in Postoperative PCA for Gynecologic Patients

  1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
  2. This study was designed to investigate the interaction between nalbuphine and morphine

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
  2. This study was designed to investigate the interaction between nalbuphine and morphine
  3. The analgesic effect and opioid-related side effects will be investigated

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Wei-Zen Sun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age 18-65 y/o
  2. Female patients of ASA physical status I to III
  3. Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian tumor

Exclusion Criteria:

  1. Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants)
  2. Intraoperative fentanyl use > 3 μg/kg
  3. Patients with definite diagnosis of esophageal reflux syndrome
  4. Use of sedatives, antiemetics, or antipruritics within 24 hours before operation
  5. Surgery > 4 hours or laparoscopy surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
analgesic effect

Secondary Outcome Measures

Outcome Measure
incidence of opioid-related side effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Wei-Zen Sun, MD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 23, 2005

Last Update Submitted That Met QC Criteria

November 22, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 931002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe