Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

Sponsor

Peking University First Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03288428

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Nalbuphine Drug: Morphine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

double blind

Primary Purpose:

Treatment

Official Title:

Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

Actual Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

numerical rating scale [24 hr post-operatively]
1-10

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First hospital Peking University	Beijing	Beijing	China

Sponsors and Collaborators

Peking University First Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yan Zhou, MD, MD, Peking University First Hospital

ClinicalTrials.gov Identifier:

NCT03288428

Other Study ID Numbers:

NABUMORPHINE

First Posted:

Sep 20, 2017

Last Update Posted:

Nov 6, 2017

Last Verified:

Nov 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Morphine

Nalbuphine

Study Results

No Results Posted as of Nov 6, 2017