Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

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: NCT04360135
Recruitment Status : Suspended (PI has decided to put this study on hold at this time.)
First Posted : April 24, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: Acetaminophen Drug: Placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial
Estimated Study Start Date : April 5, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Preemptive acetominophen
Acetaminophen 975mg BID the day before surgery and again 30-60 minutes preoperatively
Drug: Acetaminophen
Preemptive acetaminophen the day before surgery

Placebo Comparator: Standard of care
Placebo the day before surgery and acetaminophen 30-60 minutes preoperatively
Drug: Placebo
Preemptive placebo the day before surgery




Primary Outcome Measures :
  1. 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.



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 to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04360135


Locations
Layout table for location information
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Holly Yettaw, MD Montefiore Medical Center
Layout table for additonal information
Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04360135    
Other Study ID Numbers: 2019-10702
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
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