Tailored PCA Based on Preoperative Pain Sensitivity

Seoul National University

Status: Completed

Conditions: Analgesia, Patient-Controlled

Treatments: Other: Tailored regimen of IV PCA according to pain sensitivity; Other: Regimen of IV PCA without considering pain sensitivity

Study type: Interventional

Funder types: Other

Identifiers

NCT03252977

H-1707-078-869

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups

Tailored group

Experimental group

Description:

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.

Treatment:

Other: Tailored regimen of IV PCA according to pain sensitivity

control group

Sham Comparator group

Description:

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.

Treatment:

Other: Regimen of IV PCA without considering pain sensitivity