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Completed

NCT Number: NCT02116257

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

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.

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Key information

Conditions

PONV Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Propacetamol Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for either 1-2 level spine fusion or laminectomy
  • ASA (American Society of Anesthesiology) physical status 1 or 2
  • Non-smoking female patients, between the age 20 and 65

Exclusion criteria

  • Administration of any anti-emetic agents within 24 hours prior to surgery
  • Administration of any opioid agents within 7 days prior to surgery
  • Regular administration of any steroid agents
  • Drug or alcohol-abuser
  • Patients with bowel movement disorder, liver or renal impairment, insulin-dependent diabetes. Patients who are pregnant, illiterate, or foreign.
  • Patients administered to Intensive Care Unit after surgery

Treatment and study plan

Propacetamol

Drug

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

PCA regimen

Drug

Primary outcomes

  1. Incidence of PONV

    Time frame: from immediate postop to 24 hours after the surgery

    Incidence of postoperative nausea, vomiting - Number of events

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2014
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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