Clinical trial NCT03252977: Tailored PCA Based on Preoperative Pain Sensitivity
Official title: The Effectiveness of Tailored Patient Controlled Analgesia Based on Preoperative Pain Sensitivity in Gynecological Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia, Patient-Controlled
Keywords: fentanyl
Pain Threshold
predicted
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: postoperative nausea
timeFrame: during the postoperative 3 days
Secondary outcomes:
measure: postoperative pain scores
timeFrame: during the postoperative 3 days
measure: incidence of postoperative vomiting
timeFrame: during the postoperative 3 days
measure: Severity of postoperative nausea
timeFrame: during the postoperative 3 days
measure: Incidence of other postoperative adverse effects
timeFrame: during the postoperative 3 days
measure: cumulative dose of drug that infused via IV PCA
timeFrame: during the postoperative 3 days
measure: Incidence of IV PCA clamping
timeFrame: during the postoperative 3 days
measure: rescue analgesics
timeFrame: during the postoperative 3 days
measure: antiemetic agents
timeFrame: during the postoperative 3 days
measure: satisfaction score
timeFrame: during the postoperative 3 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/00000542-200509000-00026.