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Preoperative Cesarean Section Intravenous Acetaminophen and Postoperative Pain Control

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ClinicalTrials.gov Identifier: NCT02694653
Recruitment Status : Unknown
Verified April 2017 by Dr. James Neutens, University of Tennessee Graduate School of Medicine.
Recruitment status was:  Enrolling by invitation
First Posted : February 29, 2016
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. James Neutens, University of Tennessee Graduate School of Medicine

Brief Summary:
To evaluate the use of maternal opiates for pain control post cesarean delivery in those patients that received intravenous acetaminophen 1000 mg in 150 mL of normal saline, infused 30 minutes prior to incision compared to placebo. A comparison of post delivery length of stay in both study groups will be evaluated for cost effectiveness of the use of acetaminophen. a secondary purpose is to determine the levels of neonatal acetaminophen in cord blood at the time of delivery, since this has never been studied.

Condition or disease Intervention/treatment Phase
Complications; Cesarean Section Drug: Placebo Drug: Acetaminophen Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Preoperative Cesarean Section Intravenous Acetaminophen and Postoperative Pain Control: A Blinded Randomized Placebo-Controlled Trial
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Drug Arm
Acetaminophen 1000 mg in 100 mL normal saline IV administered 30 minutes prior to c/section incision to infuse within 15 minutes
Drug: Acetaminophen
1000 mg acetaminophen in 100 mL normal saline IV given 30 minutes prior to elective c/section incision vs placebo
Other Name: Tylenol

Placebo Comparator: Placebo Arm
100 mL normal saline IV administered 30 minutes prior to c/section incision to infuse within 15 minutes
Drug: Placebo
100 mL of normal saline IV given 30 minutes prior to elective c/section incision vs acetaminophen 1000 mg IV
Other Name: Normal Saline




Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Up to 26 months ]
    Maximum follow up time for assessment


Secondary Outcome Measures :
  1. Milligrams of narcotics given [ Time Frame: Up to 26 months ]
    Maximum follow up time for assessment

  2. Milligrams of Acetaminophen in cord blood [ Time Frame: At delivery ]
    Milligrams of Acetaminophen in cord blood at delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant having an elective c/section

Exclusion Criteria:

  • Acetaminophen allergy
  • Hepatitis history
  • Liver or kidney disease
  • Use of Tylenol within 24 hours
  • Use of opiates within 24 hours

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): NCT02694653


Sponsors and Collaborators
University of Tennessee Graduate School of Medicine
Investigators
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Principal Investigator: Craig V. Towers, MD University of Tennessee Graduate School of Medicine

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. James Neutens, Dean, Graduate School of Medicine, University of Tennessee Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT02694653     History of Changes
Other Study ID Numbers: 3890
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Present at national medical conference and publish in medical journal
Keywords provided by Dr. James Neutens, University of Tennessee Graduate School of Medicine:
C/section, Acetaminophen
Additional relevant MeSH terms:
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Acetaminophen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics