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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03288428
Other study ID # NABUMORPHINE
Secondary ID
Status Recruiting
Phase Phase 4
First received June 11, 2017
Last updated November 1, 2017
Start date May 1, 2017
Est. completion date December 31, 2018

Study information

Verified date November 2017
Source Peking University First Hospital
Contact Yan Zhou, MD
Phone 13641202040
Email zhouyanlion@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Nalbuphine
patient controlled analgesia with Nalbuphine
Morphine
patient controlled analgesia with Morphine

Locations

Country Name City State
China First hospital Peking University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary numerical rating scale 1-10 24 hr post-operatively
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