Postoperative Pain and Discomfort After Orbital Decompression

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

Official Title
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Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Orbital Decompression

Conditions
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Surgery, Anesthesia, Pain

Intervention / Treatment
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* Drug: Nalbuphine
* Drug: Flurbiprofen Axetil
* Drug: Nalbuphine and Flurbiprofen Axetil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flurbiprofen axetil<br>flurbiprofen axetil intraoperative administration 100mg | Drug: Flurbiprofen Axetil<br>* Flurbiprofen axetil administration during surgery<br>|
| Experimental: nalbuphine<br>nalbuphine intraoperative administration 0.1mg/kg | Drug: Nalbuphine<br>* Nalbuphine administration during surgery<br>|
| Experimental: nalbuphine and flurbiprofen axetil<br>flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg | Drug: Nalbuphine and Flurbiprofen Axetil<br>* Nalbuphine and Flurbiprofen Axetil administration during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 hour after recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hour after recovery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, general anesthesia, postoperative discomfort