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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
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring postoperative pain, general anesthesia, postoperative discomfort

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 7, 2018
Last Updated
December 22, 2018
Sponsor
Sun Yat-sen University
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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

Learn more about this trial

Postoperative Pain and Discomfort After Orbital Decompression

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