IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-operative Pain
Intervention: IV Acetaminophen (Drug); Saline as placebo (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s): Jeffrey Bernstein, MD, Principal Investigator, Affiliation: Montefiore Medical Center
Overall contact: Jeffrey Bernstein, MD, Phone: 718-920-4316, Email: jbernste@montefiore.org
Summary
Post-operative pain management after C-section is an important topic as the number of
elective c-sections increases each year. Pain is managed either by giving opioids or by
using non-opioids. The purpose of this study is to evaluate the effectiveness of IV
Acetaminophen in pain relief and its impact in the usage of post-operative opioid
requirements and opioid associated complications. The hypothesis is that four doses of IV
Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients
after c-section will reduce post-operative opioid requirements and opioid associated
complications.
Clinical Details
Official title: Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Opioid requirements in cesarean section (c-section) patient population
Secondary outcome: Visual Analog Score (VAS) pain scoreSedation level Adverse events (nausea, vomiting, pruritus and breathing difficulties) after the surgery Number of patient-controlled analgesia (PCA) attempts Re-hospitalization Pain medication usage
Detailed description:
Most of the opioids used are centrally acting drugs like morphine or its derivatives. The
most common adverse reactions related to systemic administration of opioids are sedation,
itching, constipation and less commonly, respiratory depression. One of the other management
strategies for the pain control is the use of non-steroidal anti-inflammatory drugs
(NSAIDS). Frequent use of NSAIDS is also associated with complications, such as gastric
ulcer and platelet dysfunction. When compared to other non-NSAIDS, IV acetaminophen is a
relatively safer drug with quicker onset of action. In an earlier conducted study, the onset
of action of analgesia for a bolus dose of IV acetaminophen is 3 minutes. IV acetaminophen
is FDA approved for management of mild to moderate pain. An adverse reaction associated with
the prolonged usage of IV acetaminophen is hepatic injury. The most common adverse events
encountered during previous clinical trials were nausea, vomiting, headache and insomnia.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Elective full term CS patients
- Age 18 and above
- ASA I-III
Exclusion Criteria:
- Allergic reaction to IV acetaminophen
- Not able to understand and sign the research consent
- Pregnancy induced hypertension or pre-eclampsia patients
- Planned intensive care admission patients
- Patients with severe hepatic impairment or active liver diseases (Two fold increase
in any of the liver enzymes)
- Patients with serum creatinine>2mg/dl
- For nursing mothers, any evidence of hepatic dysfunction of the new born
Locations and Contacts
Jeffrey Bernstein, MD, Phone: 718-920-4316, Email: jbernste@montefiore.org
Montefiore Medical Center- Weiler, Bronx, New York 10467, United States; Recruiting Jeffrey Bernstein, MD, Phone: 718-920-4316, Email: jbernste@montefiore.org Jeffrey Bernstein, MD, Principal Investigator
Additional Information
Starting date: November 2013
Last updated: February 19, 2014
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