Tailored PCA Based on Preoperative Pain Sensitivity

NCT03252977 | Completed

• 1 other identifier: H-1707-078-869
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• postoperative nausea

  Incidence of postoperative nausea

  during the postoperative 3 days

Secondary Outcomes (9)

• postoperative pain scores

  during the postoperative 3 days

• incidence of postoperative vomiting

  during the postoperative 3 days

• Severity of postoperative nausea

  during the postoperative 3 days

• Incidence of other postoperative adverse effects

  during the postoperative 3 days

• cumulative dose of drug that infused via IV PCA

  during the postoperative 3 days

Study Arms (2)

Tailored group

EXPERIMENTAL

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

control group

SHAM COMPARATOR

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

Interventions

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.

Tailored group

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.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related 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.

  PMID: 24517836 BACKGROUND

• 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.

  PMID: 16129988 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin-Tae Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: August 21, 2017
• Primary Completion: November 21, 2017
• Study Completion: November 24, 2017
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)