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Postoperative Pain and Discomfort After Oculoplastic Surgery

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ClinicalTrials.gov Identifier: NCT03422887
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : May 1, 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:
The purpose of this study is to evaluate patients under oculoplastic surgery over 16 years old of the postoperative pain and discomfort after general anesthesia , using flurbiprofen axetil or nalbuphine administration, and to analyze the related factors of pain and discomfort after operation.

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 : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: flurbiprofen axetil
  1. undergoing oculoplastic surgery under general anesthesia
  2. over 16 years old
  3. flurbiprofen axetil administration
Drug: Flurbiprofen Axetil
Flurbiprofen axetil administration during surgery
Experimental: nalbuphine
  1. undergoing oculoplastic surgery under general anesthesia
  2. over 16 years old
  3. nalbuphine administration
Drug: Nalbuphine
Nalbuphine administration during surgery
Active Comparator: nalbuphine and flurbiprofen axetil
  1. undergoing oculoplastic surgery under general anesthesia
  2. over 16 years old
  3. nalbuphine and flurbiprofen axetil administration
Drug: Nalbuphine and Flurbiprofen Axetil
Nalbuphine and Flurbiprofen Axetil administration during surgery



Primary Outcome Measures :
  1. Pain after oculoplastic surgery [ Time Frame: 24 hour 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 after oculoplastic surgery [ 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 and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 16 years old
  • diagnosed as oculoplastic diseases
  • surgery under general anesthesia

Exclusion Criteria:

  • any uncontrolled clinical problems

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: May 1, 2018
Last Verified: April 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:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
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