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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03252977
Other study ID # H-1707-078-869
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 21, 2017
Est. completion date November 24, 2017

Study information

Verified date December 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tailored 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.
Regimen of IV PCA without considering pain sensitivity
In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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

Outcome

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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