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

Yonsei University

Status: Completed

Conditions: PONV; Propacetamol

Treatments: Drug: Propacetamol; Drug: PCA regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT02116257

4-2013-0702

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups, including a placebo group

Propacetamol

Experimental group

Treatment:

Drug: Propacetamol

PCA regimen

Placebo Comparator group

Description:

routine PCA drug

Treatment:

Drug: PCA regimen