Surgery, Anesthesia, Pain
Conditions
Keywords
postoperative pain, general anesthesia, postoperative discomfort
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
Interventions
DRUGNalbuphine
Nalbuphine administration during surgery
Flurbiprofen axetil administration during surgery
Nalbuphine and Flurbiprofen Axetil administration during surgery
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
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
* body mass index (BMI) \<18.5 or \>35 * any uncontrolled clinical problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed