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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

Tracking Information
First Submitted Date  ICMJE June 25, 2015
First Posted Date  ICMJE July 1, 2015
Results First Submitted Date  ICMJE July 30, 2018
Results First Posted Date  ICMJE December 5, 2018
Last Update Posted Date December 5, 2018
Actual Study Start Date  ICMJE March 17, 2015
Actual Primary Completion Date July 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
Cumulative Postoperative Opiate Consumption [ Time Frame: 24 hours ]
Cumulative opiate consumption (IV morphine equivalents)
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
Total opiate consumption 24 hours following Cesarean delivery [ Time Frame: 24 hours ]
Total opiate consumption (IV morphine equivalents) 24 hours postoperatively following cesarean delivery
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Time to First Opiate Rescue [ Time Frame: 48 hours ]
    Time to first opiate pain medicine requested by patient
  • 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]) .
  • Time Discharge [ Time Frame: 24 hours postoperative ]
    Time patient meets discharge criteria will be recorded
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
  • Time to First Opiate Rescue [ Time Frame: 48 hours ]
    Time to first opiate pain medicine requested by patient
  • VAS (Visual Analog Scale) [ Time Frame: 24 hours ]
    VAS pain assessment will be completed by patient postoperatively
  • Time Discharge [ Time Frame: 24-72 hours postoperative ]
    Time patient meets discharge criteria will be recorded
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
Official Title  ICMJE Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: Acetaminophen Intravenous
    IV 1 gram f3 doses over 24 hours
    Other Name: Tylenol
  • Drug: Acetaminophen Oral
    Oral 1 gram 3 doses over 24 hours
    Other Name: Tylenol
Study Arms  ICMJE
  • Active Comparator: Acetaminophen Intravenous
    (group 1) 1 gram IV acetaminophen every 8 hours for three doses
    Intervention: Drug: Acetaminophen Intravenous
  • Active Comparator: Acetaminophen Oral
    (group 2) 1 gram oral acetaminophen every 8 hours for three doses
    Intervention: Drug: Acetaminophen Oral
  • No Intervention: No acetaminophen
    (group 3) no acetaminophen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
148
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2015)
141
Actual Study Completion Date  ICMJE July 27, 2017
Actual Primary Completion Date July 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02487303
Other Study ID Numbers  ICMJE Pro00041193
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sylvia Wilson, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP