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Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

NCT ID: NCT03288428

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
double blind

Study Groups

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nalbuphine

using nalbuphine for patient controlled analgesia

Group Type EXPERIMENTAL

Nalbuphine

Intervention Type DRUG

patient controlled analgesia with Nalbuphine

morphine

using morphine for patient controlled analgesia

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

patient controlled analgesia with Morphine

Interventions

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Nalbuphine

patient controlled analgesia with Nalbuphine

Intervention Type DRUG

Morphine

patient controlled analgesia with Morphine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yan Zhou, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First hospital Peking University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Zhou, MD

Role: CONTACT

Phone: 13641202040

Email: [email protected]

Facility Contacts

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Yan Zhou, doctor

Role: primary

Other Identifiers

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NABUMORPHINE

Identifier Type: -

Identifier Source: org_study_id