Nalbuphine and Flurbiprofen for Oculoplastic Surgery

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03422887

Collaborator

(none)

330

Enrollment

Location

Arms

8.4

Actual Duration (Months)

39.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Anesthesia Pain	Drug: Nalbuphine Drug: Flurbiprofen Axetil Drug: Nalbuphine and Flurbiprofen Axetil	N/A

Detailed Description

In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.

Study Design

Study Type:

Interventional

Actual Enrollment :

330 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Oculoplastic Surgery

Actual Study Start Date :

Jan 18, 2018

Actual Primary Completion Date :

Aug 31, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: flurbiprofen axetil flurbiprofen axetil intraoperative administration 100mg	Drug: Flurbiprofen Axetil Flurbiprofen axetil administration during surgery
Experimental: nalbuphine nalbuphine intraoperative administration 0.1mg/kg	Drug: Nalbuphine Nalbuphine administration during surgery
Experimental: nalbuphine and flurbiprofen axetil flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg	Drug: Nalbuphine and Flurbiprofen Axetil Nalbuphine and Flurbiprofen Axetil administration during surgery

Arm

Intervention/Treatment

Active Comparator: flurbiprofen axetil

flurbiprofen axetil intraoperative administration 100mg

Drug: Flurbiprofen Axetil

Flurbiprofen axetil administration during surgery

Experimental: nalbuphine

nalbuphine intraoperative administration 0.1mg/kg

Drug: Nalbuphine

Nalbuphine administration during surgery

Experimental: nalbuphine and flurbiprofen axetil

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

Drug: Nalbuphine and Flurbiprofen Axetil

Nalbuphine and Flurbiprofen Axetil administration during surgery

Outcome Measures

Primary Outcome Measures

Pain 24 hours after recovery [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).

Secondary Outcome Measures

Discomfort 24 hours after recovery [24 hour after recovery]
Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as "sensation other than pain" and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score ≥5) any time postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Study Director: Huijing Ye, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huijing Ye, Principal Investigator, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03422887

Other Study ID Numbers:

201802

First Posted:

Feb 6, 2018

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Keywords provided by Huijing Ye, Principal Investigator, Sun Yat-sen University

postoperative pain

general anesthesia

postoperative discomfort

Additional relevant MeSH terms:

Flurbiprofen

Flurbiprofen axetil

Nalbuphine

Study Results

No Results Posted as of Feb 1, 2021