NCT03422887

Brief Summary

The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after oculoplastic surgery under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable surgery

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

First Submitted

Initial submission to the registry

January 18, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

January 18, 2018

Last Update Submit

January 29, 2021

Conditions

SurgeryAnesthesiaPain

Keywords

postoperative paingeneral anesthesiapostoperative discomfort

Outcome Measures

Primary Outcomes (1)

  • Pain 24 hours after recovery

    Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5).

    24 hours after recovery

Secondary Outcomes (1)

  • Discomfort 24 hours after recovery

    24 hour after recovery

Study Arms (3)

flurbiprofen axetil

ACTIVE COMPARATOR

flurbiprofen axetil intraoperative administration 100mg

Drug: Flurbiprofen Axetil

nalbuphine

EXPERIMENTAL

nalbuphine intraoperative administration 0.1mg/kg

Drug: Nalbuphine

nalbuphine and flurbiprofen axetil

EXPERIMENTAL

flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg

Drug: Nalbuphine and Flurbiprofen Axetil

Interventions

NalbuphineDRUG

Nalbuphine administration during surgery

nalbuphine
Flurbiprofen AxetilDRUG

Flurbiprofen axetil administration during surgery

flurbiprofen axetil
Nalbuphine and Flurbiprofen AxetilDRUG

Nalbuphine and Flurbiprofen Axetil administration during surgery

nalbuphine and flurbiprofen axetil

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing oculoplastic surgery
  • age between 16 and 75 years
  • American Society of Anesthesiologists (ASA) physical status of I-II

You may not qualify if:

  • serious coexisting disease
  • body mass index (BMI) \<18.5 or \>35
  • contraindications or previous adverse reactions to any of the drugs used
  • females with a positive pregnancy test
  • patients unable to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Nalbuphineflurbiprofen axetil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Huijing Ye

    Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2018

First Posted

February 6, 2018

Study Start

January 18, 2018

Primary Completion

August 31, 2018

Study Completion

September 30, 2018

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

CN(1)