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Nalbuphine and Flurbiprofen for Oculoplastic Surgery

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ClinicalTrials.gov Identifier: NCT03422887
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Huijing Ye, 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.

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


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




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.



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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

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


Contacts
Contact: Huijing Ye +00862087331539 yehuijing@qq.com
Contact: Huasheng Yang +00862087331539 yanghs64@126.com

Locations
China, Guangdong
Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Huijing Ye, Master    00862087331539    yehuijing@qq.com   
Contact: Huasheng Yang, Doctor    00862087331539    yanghs64@126.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Huijing Ye Sun Yat-sen University

Responsible Party: Huijing Ye, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03422887     History of Changes
Other Study ID Numbers: 201802
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Nalbuphine
Flurbiprofen
Flurbiprofen axetil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action