Analgesia, Patient-Controlled Clinical Trial
Official title:
The Effectiveness of Tailored Patient Controlled Analgesia Based on Preoperative Pain Sensitivity in Gynecological Patients
Verified date | December 2018 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | November 24, 2017 |
Est. primary completion date | November 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative nausea | Incidence of postoperative nausea | during the postoperative 3 days | |
Secondary | postoperative pain scores | numeric rating scale | during the postoperative 3 days | |
Secondary | incidence of postoperative vomiting | incidence of postoperative vomiting | during the postoperative 3 days | |
Secondary | Severity of postoperative nausea | numeric rating scale | during the postoperative 3 days | |
Secondary | Incidence of other postoperative adverse effects | itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression | during the postoperative 3 days | |
Secondary | cumulative dose of drug that infused via IV PCA | cumulative dose of drug that infused via IV PCA | during the postoperative 3 days | |
Secondary | Incidence of IV PCA clamping | Incidence of IV PCA clamping | during the postoperative 3 days | |
Secondary | rescue analgesics | amount of administered rescue analgesics | during the postoperative 3 days | |
Secondary | antiemetic agents | amount of administered antiemetic agents | during the postoperative 3 days | |
Secondary | satisfaction score | Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied) | during the postoperative 3 days |
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