Tailored PCA Based on Preoperative Pain Sensitivity
- Conditions
- Analgesia, Patient-Controlled
- Interventions
- Other: Tailored regimen of IV PCA according to pain sensitivityOther: Regimen of IV PCA without considering pain sensitivity
- Registration Number
- NCT03252977
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tailored group Tailored regimen of IV PCA according to pain sensitivity Tailored regimen of IV PCA according to pain sensitivity The regimen of IV PCA will be determined according to preoperative pain sensitivity of patients. Pressure pain threshold will be measured preoperatively in these patients using pressure algometer. Patients with low pain threshold will use high dose IV PCA containing fentanyl 1500mcg, while patients with high pain threshold will use low dose IV PCA containing fentanyl 1000mcg. control group Regimen of IV PCA without considering pain sensitivity Regimen of IV PCA without considering pain sensitivity The regimen of IV PCA will be determined according to experimental group patient assignments. Pressure pain threshold will not be measured in these patients. Patients will use IV PCA with fentanyl 1000mcg or fentanyl 1500mcg. The determination will be paired to assignment of experimental group.
- Primary Outcome Measures
Name Time Method postoperative nausea during the postoperative 3 days Incidence of postoperative nausea
- Secondary Outcome Measures
Name Time Method 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
Incidence of IV PCA clamping during the postoperative 3 days Incidence of IV PCA clamping
rescue analgesics during the postoperative 3 days amount of administered rescue analgesics
antiemetic agents during the postoperative 3 days amount of administered antiemetic agents
postoperative pain scores during the postoperative 3 days numeric rating scale
cumulative dose of drug that infused via IV PCA during the postoperative 3 days cumulative dose of drug that infused via IV PCA
satisfaction score during the postoperative 3 days Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied)
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of