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Nalbuphine and Flurbiprofen for Oculoplastic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03422887
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Huijing Ye, Sun Yat-sen University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : January 18, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422887


Locations
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China, Guangdong
Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: Huijing Ye Sun Yat-sen University
More Information
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Responsible Party: Huijing Ye, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03422887    
Other Study ID Numbers: 201802
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huijing Ye, Sun Yat-sen University:
postoperative pain
general anesthesia
postoperative discomfort
Additional relevant MeSH terms:
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Flurbiprofen
Flurbiprofen axetil
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action