IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

NCT ID: NCT02069184

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-12-31

Brief 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.

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.

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IV Acetaminophen

IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours.

Group Type: EXPERIMENTAL

IV Acetaminophen

Intervention Type: DRUG

1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly

Saline as placebo

IV form, total 4 units, each given every 6th hourly in 24 hours.

Group Type: EXPERIMENTAL

Saline as placebo

Intervention Type: OTHER

100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.

Interventions

IV Acetaminophen

1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly

Intervention Type: DRUG

Saline as placebo

100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.

Intervention Type: OTHER

Other Intervention Names

IV Tylenol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Singh Nair

Asst Prof, Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center- Weiler

The Bronx, New York, United States

Countries

United States

References

Bernstein J, Spitzer Y, Ohaegbulam K, Reddy S, Song J, Romanelli E, Nair S. The analgesic efficacy of IV acetaminophen for acute postoperative pain in C-section patients: a randomized, double-blind, placebo-controlled study. J Matern Fetal Neonatal Med. 2022 Mar;35(5):933-940. doi: 10.1080/14767058.2020.1735337. Epub 2020 Mar 10.

Reference Type: DERIVED

PMID: 32156175 (View on PubMed)

Other Identifiers

13-07-144

Identifier Type: -

Identifier Source: org_study_id