Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02069184
Recruitment Status : Completed
First Posted : February 24, 2014
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Singh Nair, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: IV Acetaminophen Other: Saline as placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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 Name: 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.




Primary Outcome Measures :
  1. Opioid Requirements in Cesarean Section (C-section) Patient Population [ Time Frame: 24 and 48 hours after Cesarean Section ]

Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069184


Locations
Layout table for location information
United States, New York
Montefiore Medical Center- Weiler
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey Bernstein, MD Montefiore Medical Center

Layout table for additonal information
Responsible Party: Singh Nair, Asst Prof, Anesthesiology, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02069184     History of Changes
Other Study ID Numbers: 13-07-144
First Posted: February 24, 2014    Key Record Dates
Results First Posted: August 22, 2019
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Singh Nair, Montefiore Medical Center:
opioid usage requirements
pain
IV acetaminophen
opioid usage
c-section
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics