- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03288428
Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy
May 16, 2026 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
Completed
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 (Actual)
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 Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- First hospital Peking University
-
-
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
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: nalbuphine
using nalbuphine for patient controlled analgesia
|
patient controlled analgesia with Nalbuphine
|
|
Active Comparator: morphine
using morphine for patient controlled analgesia
|
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
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 (Actual)
December 31, 2018
Study Completion (Actual)
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)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 16, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Heterocyclic Compounds
- Heterocyclic Compounds, Fused-Ring
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Polycyclic Compounds
- Heterocyclic Compounds, 4 or More Rings
- Morphinans
- Opiate Alkaloids
- Heterocyclic Compounds, Bridged-Ring
- Phenanthrenes
- Morphine Derivatives
- Morphine
- Nalbuphine
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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