Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

November 1, 2017 updated by: Yan Zhou, MD, Peking University First Hospital
to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy, by using patient controlled analgesia postoperatively, a randomized, double blind clinical trial. Patients undergoing elective Laparoscopic myomectomy are randomly divided into two groups: nalbuphine and morphine groups. All patients are under general anesthesia with routine methods. The nalbuphine group receive postoperative patient controlled analgesia using nalbuphine 30mg/120ml, while the morphine group receive postoperative patient controlled analgesia using morphine 60mg/120ml. Perioperative parameters are to be collected to compare the two groups.

Study Type

Interventional

Enrollment (Anticipated)

80

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 Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • First hospital Peking University
        • Contact:

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective Laparoscopic myomectomy patients 24hr post-operative patient controlled analgesia analgesia no mild or severe liver or renal disfunction

Exclusion Criteria:

  • can't understand patient controlled analgesia device refuse trial

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: nalbuphine
using nalbuphine for patient controlled analgesia
Drug: Nalbuphine
patient controlled analgesia with Nalbuphine
ACTIVE_COMPARATOR: morphine
using morphine for patient controlled analgesia
Drug: Morphine
patient controlled analgesia with Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numerical rating scale
Time Frame: 24 hr post-operatively
1-10
24 hr post-operatively

Collaborators and Investigators

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

Sponsor

Peking University First 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 (ACTUAL)

May 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

June 11, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (ACTUAL)

September 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NABUMORPHINE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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