The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV

NCT ID: NCT02116257

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-03-31

Brief Summary

While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the degree of postoperative pain, it can also affect the patient's outcome by several adverse effects such as postoperative nausea and vomiting (PONV). Especially for high risk group of patients for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and is used widely for post operative pain management. This study aims to see the opioid-sparing effect and the degree of PONV when propacetamol is added to PCA for high risk PONV patients.

Conditions

PONV; Propacetamol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Propacetamol

Group Type: EXPERIMENTAL

Propacetamol

Intervention Type: DRUG

total 4g of Propacetamol added to patient's PCA regimen

PCA regimen

routine PCA drug

Group Type: PLACEBO_COMPARATOR

PCA regimen

Intervention Type: DRUG

Interventions

Propacetamol

total 4g of Propacetamol added to patient's PCA regimen

Intervention Type: DRUG

PCA regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients scheduled for either 1-2 level spine fusion or laminectomy

2. ASA (American Society of Anesthesiology) physical status 1 or 2

3. Non-smoking female patients, between the age 20 and 65

Exclusion Criteria

1. Administration of any anti-emetic agents within 24 hours prior to surgery

2. Administration of any opioid agents within 7 days prior to surgery

3. Regular administration of any steroid agents

4. Drug or alcohol-abuser

5. Patients with bowel movement disorder, liver or renal impairment, insulin-dependent diabetes. Patients who are pregnant, illiterate, or foreign.

6. Patients administered to Intensive Care Unit after surgery

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2013-0702

Identifier Type: -

Identifier Source: org_study_id