CClinicalTrials.gg
CompletedNCT03562611Updated Dec 26, 2018

Postoperative Pain and Discomfort After Orbital Decompression

An interventional study of Nalbuphine and Flurbiprofen Axetil in Surgery, Anesthesia and Pain, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-26.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
16 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression

02

Conditions studied

  • Surgery
  • Anesthesia
  • Pain

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Keywords

  • postoperative pain
  • general anesthesia
  • postoperative discomfort
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 63 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • body mass index (BMI) \<18.5 or >35
  • any uncontrolled clinical problems
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Active comparator
    flurbiprofen axetil

    flurbiprofen axetil intraoperative administration 100mg

    Drug: Flurbiprofen Axetil

  • Experimental
    nalbuphine

    nalbuphine intraoperative administration 0.1mg/kg

    Drug: Nalbuphine

  • Experimental
    nalbuphine and flurbiprofen axetil

    flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg

    Drug: Nalbuphine and Flurbiprofen Axetil

Interventions

  • DrugNalbuphine

    Nalbuphine administration during surgery

  • DrugFlurbiprofen Axetil

    Flurbiprofen axetil administration during surgery

  • DrugNalbuphine and Flurbiprofen Axetil

    Nalbuphine and Flurbiprofen Axetil administration during surgery

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 24 hour after recovery

Secondary outcomes

  1. 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.

    Time frame: 24 hour after recovery

07

Study locations

1 site
  • Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03562611
Lead sponsor
Sun Yat-sen University
Responsible party
Huijing Ye (Principal Investigator, Sun Yat-sen University) — Principal investigator
First posted
Jun 19, 2018
Start date
Jun 8, 2018
Primary completion
Sep 8, 2018
Completion
Sep 30, 2018
Last update
Dec 26, 2018

Study contacts

Huijing Ye
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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