Back to resultsAnalgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nalbuphine
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- First hospital Peking UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nalbuphine
morphine
Arm Description
using nalbuphine for patient controlled analgesia
using morphine for patient controlled analgesia
Outcomes
Primary Outcome Measures
numerical rating scale
1-10
Secondary Outcome Measures
Full Information
NCT ID
NCT03288428
First Posted
June 11, 2017
Last Updated
November 1, 2017
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03288428
Brief Title
Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy
Official Title
Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nalbuphine
Arm Type
Experimental
Arm Description
using nalbuphine for patient controlled analgesia
Arm Title
morphine
Arm Type
Active Comparator
Arm Description
using morphine for patient controlled analgesia
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Intervention Description
patient controlled analgesia with Nalbuphine
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
patient controlled analgesia with Morphine
Primary Outcome Measure Information:
Title
numerical rating scale
Description
1-10
Time Frame
24 hr post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhou, MD
Phone
13641202040
Email
zhouyanlion@163.com
Facility Information:
Facility Name
First hospital Peking University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhou, doctor
Phone
13641202040
Email
anesth.zhouyan9@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy
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