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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02116257
Enrollment
108
Registered
2014-04-16
Start date
2013-11-30
Completion date
2015-03-31
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PONV, Propacetamol

Keywords

Nausea, Vomiting

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.

Interventions

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

DRUGPCA regimen

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of PONVfrom immediate postop to 24 hours after the surgeryIncidence of postoperative nausea, vomiting - Number of events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026