Postoperative Pain and Discomfort After Orbital Decompression
Primary Purpose
Surgery, Anesthesia, Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nalbuphine
Flurbiprofen Axetil
Nalbuphine and Flurbiprofen Axetil
Sponsored by
About this trial
This is an interventional treatment trial for Surgery focused on measuring postoperative pain, general anesthesia, postoperative discomfort
Eligibility 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
Sites / Locations
- Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
flurbiprofen axetil
nalbuphine
nalbuphine and flurbiprofen axetil
Arm Description
flurbiprofen axetil intraoperative administration 100mg
nalbuphine intraoperative administration 0.1mg/kg
flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg
Outcomes
Primary Outcome Measures
Pain after orbital decompression
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
Discomfort after orbital decompression
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03562611
Brief Title
Postoperative Pain and Discomfort After Orbital Decompression
Official Title
Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Orbital Decompression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 8, 2018 (Actual)
Primary Completion Date
September 8, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Anesthesia, Pain
Keywords
postoperative pain, general anesthesia, postoperative discomfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
flurbiprofen axetil
Arm Type
Active Comparator
Arm Description
flurbiprofen axetil intraoperative administration 100mg
Arm Title
nalbuphine
Arm Type
Experimental
Arm Description
nalbuphine intraoperative administration 0.1mg/kg
Arm Title
nalbuphine and flurbiprofen axetil
Arm Type
Experimental
Arm Description
flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Intervention Description
Nalbuphine administration during surgery
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen Axetil
Intervention Description
Flurbiprofen axetil administration during surgery
Intervention Type
Drug
Intervention Name(s)
Nalbuphine and Flurbiprofen Axetil
Intervention Description
Nalbuphine and Flurbiprofen Axetil administration during surgery
Primary Outcome Measure Information:
Title
Pain after orbital decompression
Description
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).
Time Frame
24 hour after recovery
Secondary Outcome Measure Information:
Title
Discomfort after orbital decompression
Description
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.
Time Frame
24 hour after recovery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huijing Ye
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Postoperative Pain and Discomfort After Orbital Decompression
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