Nalbuphine and Flurbiprofen for Oculoplastic Surgery

Not Applicable

Completed

• Conditions: Surgery; Anesthesia; Pain
• Interventions: Drug: Nalbuphine and Flurbiprofen Axetil; Drug: Flurbiprofen Axetil; Drug: Nalbuphine

• Registration Number: NCT03422887
• Lead Sponsor: Sun Yat-sen University

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.

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 Timeline

• Study Start: 2018-01-18
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Primary Completion: 2018-08-31
• Study Completion: 2018-09-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nalbuphine and flurbiprofen axetil	Nalbuphine and Flurbiprofen Axetil	flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg
flurbiprofen axetil	Flurbiprofen Axetil	flurbiprofen axetil intraoperative administration 100mg
nalbuphine	Nalbuphine	nalbuphine intraoperative administration 0.1mg/kg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China