Gynecologic Disease, Postoperative Pain
Conditions
Brief summary
This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia. Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.
Interventions
DRUGAcetaminophen
Acetaminophen will be intravenously administrated to treatment group after the end of surgery.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse
Exclusion criteria
* Liver disease (aspartate transaminase OR alanine transaminase \> 80 IU/L) * Chronic kidney disease (GFR \< 30 ml/min/1.73m2) * History of drug allergy * Chronic pain lasting more than 3 months * Conversion to laparotomy * Complex surgery (co-operation with colon surgeon or urologist) * Limitation in expressing pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total volume of administered analgesics during postoperative 24 hours | 24 hours | morphine equivalent dose of patient-controlled analgesics administered during first 24 hours after end of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction score | 24 hours | 11-point numeric rating scale ranging from '0' representing one extreme (e.g. extremely dissatisfied) to '10' representing the other extreme (e.g. extremely satisfied) |
| Postoperative nausea and vomiting | 24 hours | 4-scales scoring (none; mild; moderate; severe) |
| Pain score | 24 hours | 11-point numeric rating scale ranging from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) |
| Use of alternative analgesics | 24 hours | Additional administration of other analgesics |
| Length of stay | From date of hospital admission until the date of discharge, an average of 1 week | Hospital length of stay |
| Opioid-related adverse effect | 24 hours | Incidence of respiratory, gastrointestinal, and central nervous system complications |
Countries
South Korea
Outcome results
None listed