Nalbuphine and Flurbiprofen for Oculoplastic Surgery

Overview

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.

Full Title of Study: “Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Oculoplastic Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2018

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.

Interventions

  • Drug: Nalbuphine
    • Nalbuphine administration during surgery
  • Drug: Flurbiprofen Axetil
    • Flurbiprofen axetil administration during surgery
  • Drug: Nalbuphine and Flurbiprofen Axetil
    • Nalbuphine and Flurbiprofen Axetil administration during surgery

Arms, Groups and Cohorts

  • Active Comparator: flurbiprofen axetil
    • flurbiprofen axetil intraoperative administration 100mg
  • Experimental: nalbuphine
    • nalbuphine intraoperative administration 0.1mg/kg
  • Experimental: nalbuphine and flurbiprofen axetil
    • flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg

Clinical Trial Outcome Measures

Primary Measures

  • Pain 24 hours after recovery
    • Time Frame: 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 Measures

  • Discomfort 24 hours after recovery
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Huijing Ye, Principal Investigator – Sun Yat-sen University
  • Overall Official(s)
    • Huijing Ye, Study Director, Sun Yat-sen University

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