Postoperative Pain and Discomfort After Orbital Decompression

Not Applicable

Completed

• Conditions: Surgery; Anesthesia; Pain
• Interventions: Drug: Nalbuphine and Flurbiprofen Axetil; Drug: Flurbiprofen Axetil; Drug: Nalbuphine

• Registration Number: NCT03562611
• Lead Sponsor: Sun Yat-sen University

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

Study Timeline

• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-07
• Study Start: 2018-06-08
• Study First Posted: 2018-06-19
• Primary Completion: 2018-09-08
• Study Completion: 2018-09-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-22
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nalbuphine and flurbiprofen axetil	Nalbuphine and Flurbiprofen Axetil	flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg
flurbiprofen axetil	Flurbiprofen Axetil	flurbiprofen axetil intraoperative administration 100mg
nalbuphine	Nalbuphine	nalbuphine intraoperative administration 0.1mg/kg

Primary Outcome Measures

Name	Time	Method
Pain after orbital decompression	24 hour 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).

Secondary Outcome Measures

Name	Time	Method
Discomfort after orbital decompression	24 hour 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.

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China