Nalbuphine and Flurbiprofen for Oculoplastic Surgery

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 oculoplastic surgery under general anesthesia.

Detailed Description
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In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.

Official Title
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Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Oculoplastic Surgery

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: Undergoing oculoplastic surgery age between 16 and 75 years American Society of Anesthesiologists (ASA) physical status of I-II Exclusion Criteria: serious coexisting disease body mass index (BMI) <18.5 or >35 contraindications or previous adverse reactions to any of the drugs used females with a positive pregnancy test patients unable to cooperate

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 24 hours 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). | 24 hours after recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort 24 hours 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. | 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