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 oculoplastic surgery under general anesthesia.
Detailed description
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.
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain 24 hours after recovery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort 24 hours after recovery | 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