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Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

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: NCT02487303
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Description
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Brief Summary:
This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Acetaminophen Intravenous Drug: Acetaminophen Oral Not Applicable

Detailed Description:
This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
Actual Study Start Date : March 17, 2015
Actual Primary Completion Date : July 27, 2017
Actual Study Completion Date : July 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Acetaminophen Intravenous
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
 Drug: Acetaminophen Intravenous
IV 1 gram f3 doses over 24 hours
Other Name: Tylenol
Active Comparator: Acetaminophen Oral
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
 Drug: Acetaminophen Oral
Oral 1 gram 3 doses over 24 hours
Other Name: Tylenol
No Intervention: No acetaminophen
(group 3) no acetaminophen


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative Postoperative Opiate Consumption [ Time Frame: 24 hours ]
    Cumulative opiate consumption (IV morphine equivalents)


Secondary Outcome Measures :
  1. Time to First Opiate Rescue [ Time Frame: 48 hours ]
    Time to first opiate pain medicine requested by patient

  2. VAS (Visual Analog Scale) [ Time Frame: 24 hours ]
    Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) .

  3. Time Discharge [ Time Frame: 24 hours postoperative ]
    Time patient meets discharge criteria will be recorded


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parturients 18 years
  • Elective Cesarean delivery
  • Spinal anesthesia
  • Able to consent to the study and participate in the follow-up.

Exclusion Criteria:

  • Weight under 50 kgs
  • Allergy to acetaminophen
  • General anesthesia
  • Urgent or emergent cases
  • Bleeding diathesis or other coagulopathy
  • G6PD deficiency
  • Liver disease
  • Substance abuse or dependence
  • HELLP syndrome
  • Thrombocytopenia or platelet dysfunction
  • History or active gastrointestinal bleeding
  • Acute kidney injury or chronic renal insufficiency
  • Contraindication/refusal to spinal anesthesia
  • Chronic pain
  • Chronic narcotic use
  • Illicit drug use
  • Allergy to any study related medications.
Contacts and Locations
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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): NCT02487303


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Sylvia Wilson, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
Study Protocol and Statistical Analysis Plan  [PDF] August 31, 2015

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02487303    
Other Study ID Numbers: Pro00041193
First Posted: July 1, 2015    Key Record Dates
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018
Last Verified: November 2018
Keywords provided by Medical University of South Carolina:
Acetaminophen
Pain, Postoperative
Analgesia, Obstetrical
Cesarean Section
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics