Clinical trial NCT02069184: IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Keywords: opioid usage requirements
pain
IV acetaminophen
opioid usage
c-section
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Opioid Requirements in Cesarean Section (C-section) Patient Population
timeFrame: 24 and 48 hours after Cesarean Section
Secondary outcomes:
measure: Visual Analog Score (VAS) Pain Score
timeFrame: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours
measure: Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section
timeFrame: Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section
measure: "Percentage of Patients With Adverse Events After the Surgery
timeFrame: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge.
measure: Number of Participants Using Patient-controlled Analgesia (PCA) Attempts
timeFrame: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours.
measure: Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge
timeFrame: From time of discharge to 1 week after discharge
measure: Pain Medication Usage ( NSAIDS)
timeFrame: For the first 24 hours after the c-section until the patient is discharged or up to 48 hours
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center- Weiler
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Jeffrey Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.