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

PONV Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116257
• Other study ID #: 4-2013-0702
• Status: Completed
• Phase: N/A
• First received: April 14, 2014
• Last updated: June 23, 2015
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• PONV
• Propacetamol

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PONV	Incidence of postoperative nausea, vomiting - Number of events	from immediate postop to 24 hours after the surgery	No