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.
Brief Title
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy
Completion Date
Completion Date Type
Actual
Conditions
Post Operative Pain
Eligibility 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
* 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
Inclusion Criteria
Inclusion Criteria:
* Undergoing minimally invasive hysterectomy for benign indications
* Undergoing minimally invasive hysterectomy for benign indications
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT04360135
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10702
Overall Status
Withdrawn
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial
Primary Outcomes
Outcome Description
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.
Outcome Measure
Post-operative opioid use
Outcome Time Frame
4 hours
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Yettaw
Investigator Email
hyettaw@montefiore.org
Investigator Phone