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Completed

NCT Number: NCT03252977

Tailored PCA Based on Preoperative Pain Sensitivity

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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Key information

Conditions

Analgesia, Patient-Controlled Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. postoperative nausea

    Time frame: during the postoperative 3 days

    Incidence of postoperative nausea

Secondary outcomes

  1. postoperative pain scores

    Time frame: during the postoperative 3 days

    numeric rating scale

  2. incidence of postoperative vomiting

    Time frame: during the postoperative 3 days

    incidence of postoperative vomiting

  3. Severity of postoperative nausea

    Time frame: during the postoperative 3 days

    numeric rating scale

  4. Incidence of other postoperative adverse effects

    Time frame: during the postoperative 3 days

    itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression

  5. cumulative dose of drug that infused via IV PCA

    Time frame: during the postoperative 3 days

    cumulative dose of drug that infused via IV PCA

  6. Incidence of IV PCA clamping

    Time frame: during the postoperative 3 days

    Incidence of IV PCA clamping

  7. rescue analgesics

    Time frame: during the postoperative 3 days

    amount of administered rescue analgesics

  8. antiemetic agents

    Time frame: during the postoperative 3 days

    amount of administered antiemetic agents

  9. satisfaction score

    Time frame: during the postoperative 3 days

    Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2017
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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