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Clinical Trials/NCT03252977
NCT03252977
Completed
Not Applicable

The Effectiveness of Tailored Patient Controlled Analgesia Based on Preoperative Pain Sensitivity in Gynecological Patients

Seoul National University Hospital1 site in 1 country118 target enrollmentAugust 21, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia, Patient-Controlled
Sponsor
Seoul National University Hospital
Enrollment
118
Locations
1
Primary Endpoint
postoperative nausea
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 21, 2017
End Date
November 24, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

Associate professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

postoperative nausea

Time Frame: during the postoperative 3 days

Incidence of postoperative nausea

Secondary Outcomes

  • incidence of postoperative vomiting(during the postoperative 3 days)
  • Severity of postoperative nausea(during the postoperative 3 days)
  • Incidence of other postoperative adverse effects(during the postoperative 3 days)
  • Incidence of IV PCA clamping(during the postoperative 3 days)
  • rescue analgesics(during the postoperative 3 days)
  • antiemetic agents(during the postoperative 3 days)
  • postoperative pain scores(during the postoperative 3 days)
  • cumulative dose of drug that infused via IV PCA(during the postoperative 3 days)
  • satisfaction score(during the postoperative 3 days)

Study Sites (1)

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