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Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

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ClinicalTrials.gov Identifier: NCT04360135
Recruitment Status : Terminated (The study was closed as per final progress report 3/12/2021.)
First Posted : April 24, 2020
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE April 17, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE May 6, 2020
Actual Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
Post-operative opioid use [ Time Frame: 4 hours ]
The total amount of opiate consumption in the immediate postoperative period will be recorded. Per standard protocol, patient's will be ordered for pain medication to receive on an as needed basis. The amount of both oral and IV opioids consumed by the patient will be converted to total morphine equivalents. As such, post operative opioid use will be used as a proxy for degree of post operative pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy
Official Title  ICMJE Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial
Brief Summary This study is investigating whether administration of acetaminophen the day before surgery improves post operative pain following minimally invasive hysterectomy. Patients will receive either acetaminophen or placebo to take twice per day the day prior to their scheduled surgery. The morning of surgery all participants will receive oral acetaminophen at least 30 minutes prior to surgery. The investigators will examine whether there is a difference in post operative pain between the two groups.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Post Operative Pain
Intervention  ICMJE
  • Drug: Acetaminophen
    Preemptive acetaminophen the day before surgery
  • Drug: Placebo
    Preemptive placebo the day before surgery
Study Arms  ICMJE
  • Experimental: Preemptive acetominophen
    Acetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively
    Intervention: Drug: Acetaminophen
  • Placebo Comparator: Standard of care
    Placebo the day before surgery and acetaminophen 30-60 minutes preoperatively
    Intervention: Drug: Placebo
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 21, 2020)
208
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 12, 2021
Actual Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Undergoing minimally invasive hysterectomy for benign indications

Exclusion Criteria:

  • acetaminophen allergy
  • liver disease
  • kidney disease
  • consume >3 alcoholic beverages per day
  • weigh <50 kilograms
  • report daily opiate use
  • contraindication to acetaminophen
  • used acetaminophen within 24 hours of surgery
  • undergoing a concomitant pelvic reconstructive procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 100 Years   (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 NCT04360135
Other Study ID Numbers  ICMJE 2019-10702
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Holly Yettaw, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date May 2021

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