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Completed

NCT Number: NCT02069184

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center- Weiler

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV acetaminophen

Drug

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

Other names: IV Tylenol

Saline as placebo

Other

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

Primary outcomes

  1. Opioid Requirements in Cesarean Section (C-section) Patient Population

    Time frame: 24 and 48 hours after Cesarean Section

Secondary outcomes

  1. Visual Analog Score (VAS) Pain Score

    Time frame: 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

    Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst

  2. Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section

    Time frame: 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.

  3. "Percentage of Patients With Adverse Events After the Surgery

    Time frame: 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.

    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.

  4. Number of Participants Using Patient-controlled Analgesia (PCA) Attempts

    Time frame: 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.

    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.

  5. Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge

    Time frame: From time of discharge to 1 week after discharge

    No patients were re hospitalized in the first 7 days

  6. Pain Medication Usage ( NSAIDS)

    Time frame: For the first 24 hours after the c-section until the patient is discharged or up to 48 hours

    Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2014
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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