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

NCT02116257 | Completed

• 1 other identifier: 4-2013-0702
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• Incidence of PONV

  Incidence of postoperative nausea, vomiting - Number of events

  from immediate postop to 24 hours after the surgery

Study Arms (2)

Propacetamol

EXPERIMENTAL

Drug: Propacetamol

PCA regimen

PLACEBO COMPARATOR

routine PCA drug

Drug: PCA regimen

Interventions

Propacetamol DRUG

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

Propacetamol

PCA regimen DRUG

PCA regimen

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

propacetamol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

KR (1)