Tailored PCA Based on Preoperative Pain Sensitivity

Analgesia, Patient-Controlled Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252977
• Other study ID #: H-1707-078-869
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Analgesia, Patient-Controlled

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