Tailored PCA Based on Preoperative Pain Sensitivity

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia, Patient-Controlled
• Intervention / Treatment: Other: Tailored regimen of IV PCA according to pain sensitivity; Other: Regimen of IV PCA without considering pain sensitivity

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored group; Tailored regimen of IV PCA according to pain sensitivity The regimen of IV PCA will be determined according to preoperative pain sensitivity of patients. Pressure pain threshold will be measured preoperatively in these patients using pressure algometer. Patients with low pain threshold will use high dose IV PCA containing fentanyl 1500mcg, while patients with high pain threshold will use low dose IV PCA containing fentanyl 1000mcg.	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.
Sham Comparator: control group; Regimen of IV PCA without considering pain sensitivity The regimen of IV PCA will be determined according to experimental group patient assignments. Pressure pain threshold will not be measured in these patients. Patients will use IV PCA with fentanyl 1000mcg or fentanyl 1500mcg. The determination will be paired to assignment of experimental group.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea	Incidence of postoperative nausea	during the postoperative 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain scores	numeric rating scale	during the postoperative 3 days
incidence of postoperative vomiting	incidence of postoperative vomiting	during the postoperative 3 days
Severity of postoperative nausea	numeric rating scale	during the postoperative 3 days
Incidence of other postoperative adverse effects	itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression	during the postoperative 3 days
cumulative dose of drug that infused via IV PCA	cumulative dose of drug that infused via IV PCA	during the postoperative 3 days
Incidence of IV PCA clamping	Incidence of IV PCA clamping	during the postoperative 3 days
rescue analgesics	amount of administered rescue analgesics	during the postoperative 3 days
antiemetic agents	amount of administered antiemetic agents	during the postoperative 3 days
satisfaction score	Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied)	during the postoperative 3 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): November 21, 2017
• Study Completion (Actual): November 24, 2017

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 16, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: fentanyl; Pain Threshold; predicted
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: H-1707-078-869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No