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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored group | Experimental | 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. |
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| control group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored regimen of IV PCA according to pain sensitivity | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative nausea | Incidence of postoperative nausea | during the postoperative 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain scores | numeric rating scale | during the postoperative 3 days |
| incidence of postoperative vomiting | incidence of postoperative vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24517836 | Background | Ahmad S, De Oliveira GS Jr, Bialek JM, McCarthy RJ. Thermal quantitative sensory testing to predict postoperative pain outcomes following gynecologic surgery. Pain Med. 2014 May;15(5):857-64. doi: 10.1111/pme.12374. Epub 2014 Feb 12. | |
| 16129988 | Background | Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Regimen of IV PCA without considering pain sensitivity | Other | In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity. |
|
| during the postoperative 3 days |
| Severity of postoperative nausea | numeric rating scale | during the postoperative 3 days |
| Incidence of other postoperative adverse effects | itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression | during the postoperative 3 days |
| cumulative dose of drug that infused via IV PCA | cumulative dose of drug that infused via IV PCA | during the postoperative 3 days |
| Incidence of IV PCA clamping | Incidence of IV PCA clamping | during the postoperative 3 days |
| rescue analgesics | amount of administered rescue analgesics | during the postoperative 3 days |
| antiemetic agents | amount of administered antiemetic agents | during the postoperative 3 days |
| satisfaction score | Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied) | during the postoperative 3 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |