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

Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: IV Acetaminophen; Other: Saline as placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center- Weiler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: IV Acetaminophen; 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly; Other Names: IV Tylenol
Experimental: Saline as placebo; IV form, total 4 units, each given every 6th hourly in 24 hours.	Other: Saline as placebo; 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Opioid Requirements in Cesarean Section (C-section) Patient Population	24 and 48 hours after Cesarean Section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score (VAS) Pain Score	Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst	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
Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section	Sedation was assessed on a scale of 1-3 (1= wide awake, 2= sleepy but easily aroused, 3= sleepy and difficult to arouse). These assessments were made at the same time points as the pain assessments by the same research assistant. Score 1 is the only good outcome.	Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section
"Percentage of Patients With Adverse Events After the Surgery	Subjects were specifically asked about adverse events such as nausea, vomiting, pruritus and breathing difficulties and information regarding their bowel movements. This information was collected on a scale of none, mild, moderate or severe. These are categorical outcomes.	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.
Number of Participants Using Patient-controlled Analgesia (PCA) Attempts	Data were not collected.The use of patient-controlled analgesia (PCA) pumps could have been utilized to standardize rescue medications. This would have allowed the collection of the proportion of subjects that required additional rescue medications. This was another possible endpoint that could have been evaluated.	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.
Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge	No patients were re hospitalized in the first 7 days	From time of discharge to 1 week after discharge
Pain Medication Usage ( NSAIDS)	Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events.	For the first 24 hours after the c-section until the patient is discharged or up to 48 hours

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Jeffrey Bernstein, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 24, 2014

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: pain; c-section; IV acetaminophen; opioid usage requirements; opioid usage
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 13-07-144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED