Tailored PCA Based on Preoperative Pain Sensitivity

NCT ID: NCT03252977

Last Updated: 2018-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2017-11-24

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.

Conditions

Analgesia, Patient-Controlled

Keywords

fentanyl; Pain Threshold; predicted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tailored regimen of IV PCA according to pain sensitivity

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Regimen of IV PCA without considering pain sensitivity

Intervention Type: OTHER

In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Tae Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 24517836 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16129988 (View on PubMed)

Other Identifiers

H-1707-078-869

Identifier Type: -

Identifier Source: org_study_id