Analgesia, Patient-Controlled
Conditions
Keywords
fentanyl, Pain Threshold, predicted
Brief summary
Opioids via intravenous patient-controlled analgesia (IV PCA) are widely used for postoperative pain control. However, effective pain control with minimized side effects of analgesic agents is still challenging. Several studies reported that preoperative pain sensitivity measured by quantitative sensory test could predict postoperative pain. Therefore, the investigators planned this trial to evaluate the effectiveness of tailored patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain threshold in patients undergoing gynecological surgery.
Interventions
OTHERTailored regimen of IV PCA according to pain sensitivity
In tailored group, fentanyl dosage in IV PCA will be determined according to preoperative pain sensitivity. In control, group, fentanyl dosage in IV PCA will be determined without consideration of patient's pain sensitivity.
OTHERRegimen of IV PCA without considering pain sensitivity
In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients scheduled to undergo elective gynecological surgery under general anesthesia * patients scheduled to use IV PCA for postoperative analgesia * patients with American Society of Anesthesiologists (ASA) physical status classification I, II, III
Exclusion criteria
* contraindication to fentanyl use * inability to communication * age less than 18 years, or more than 80 years * body weight less than 40kg, or more than 90kg * morbid cardiovascular disease * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea | during the postoperative 3 days | Incidence of postoperative nausea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative vomiting | during the postoperative 3 days | incidence of postoperative vomiting |
| Severity of postoperative nausea | during the postoperative 3 days | numeric rating scale |
| Incidence of other postoperative adverse effects | during the postoperative 3 days | itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression |
| cumulative dose of drug that infused via IV PCA | during the postoperative 3 days | cumulative dose of drug that infused via IV PCA |
| postoperative pain scores | during the postoperative 3 days | numeric rating scale |
| rescue analgesics | during the postoperative 3 days | amount of administered rescue analgesics |
| antiemetic agents | during the postoperative 3 days | amount of administered antiemetic agents |
| satisfaction score | during the postoperative 3 days | Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied) |
| Incidence of IV PCA clamping | during the postoperative 3 days | Incidence of IV PCA clamping |
Countries
South Korea
Outcome results
None listed