Phase 4 N=183 Randomized Triple-blind Treatment

IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy

Pain

Bottom Line

View on ClinicalTrials.gov: NCT02400580 ↗

Enrolled (actual)

183

Serious AEs

0.5%

Results posted

Dec 2017

Primary outcome: Primary: Postoperative Pain — 3.55; 3.11 units on a visual analog scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: IV acetaminophen (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Pittsburgh
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Pain	3.55; 3.11	—
SECONDARY Narcotic Medication Use	16.4; 18.4	—

Summary

The objective of this study is to quantify the change in post-operative pain scores and narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to placebo in women undergoing laparoscopic hysterectomy.

Eligibility Criteria

Inclusion Criteria

Women aged 18-75
Ability to read and write in English (our post-operative pain log is only available in English)
Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal hysterectomy, with or without salpingooophorectomy)

Exclusion Criteria

Answering yes to any of the following questions: "Do you have a history of liver disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks per day or being have you ever been told by your doctor that they should not take acetaminophen"
History of cardiac arrhythmia
History of jaundice
Acute abdominal inflammatory or infectious process at time of surgery
Known malignancy at time of surgery
Known pregnancy at time of surgery
Plan to perform additional significant surgical procedure at the time of hysterectomy such as extensive excision of endometriosis on bowel or bladder or pelvic reconstructive procedure
>6cm abdominal incision in order to remove the uterus at time of study-related hysterectomy
Regular use of narcotic pain medication (defined as use on most days of the week at any point in the past 3 months)
Allergy to acetaminophen
Women who weigh less than 50 kilograms on the day of surgery.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02400580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.