NCT03288428

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started May 2017

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

June 11, 2017

Last Update Submit

May 16, 2026

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • numerical rating scale

    1-10

    24 hr post-operatively

Study Arms (2)

nalbuphine

EXPERIMENTAL

using nalbuphine for patient controlled analgesia

Drug: Nalbuphine

morphine

ACTIVE COMPARATOR

using morphine for patient controlled analgesia

Drug: Morphine

Interventions

NalbuphineDRUG

patient controlled analgesia with Nalbuphine

nalbuphine
MorphineDRUG

patient controlled analgesia with Morphine

morphine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective Laparoscopic myomectomy patients 24hr post-operative patient controlled analgesia analgesia no mild or severe liver or renal disfunction

You may not qualify if:

  • can't understand patient controlled analgesia device refuse trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First hospital Peking University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

NalbuphineMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsMorphine Derivatives

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 11, 2017

First Posted

September 20, 2017

Study Start

May 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations

CN(1)