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Postoperative Pain and Discomfort After Orbital Decompression

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: NCT03562611
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : December 26, 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 orbital decompression 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:
To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 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 Orbital Decompression
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : September 8, 2018
Actual Study Completion Date : September 30, 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 after orbital decompression [ 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 orbital decompression [ 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:

  • 16-75 years old
  • diagnosed as thyroid eye disease
  • bone removal orbital decompression under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status of I-II

Exclusion Criteria:

  • body mass index (BMI) <18.5 or >35
  • 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): NCT03562611


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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Principal Investigator: Huijing Ye Sun Yat-sen University
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Responsible Party: Huijing Ye, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03562611    
Other Study ID Numbers: 201806
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: December 26, 2018
Last Verified: December 2018
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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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
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