Clinical trial NCT02043704: RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
Official title: The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: IV Acetaminophen
Vaginal Reconstruction
Pain, Postoperative
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.

Detailed description: see brief summary

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18 and 70 years
* Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
* Scheduled to undergo major vaginal reconstruction
* Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.

Exclusion Criteria:

* Allergy to acetaminophen
* Liver disease (chronic or active)
* Chronic alcohol use (\>1 drink/day)
* Bleeding diathesis
* Renal disease
* Opiate dependent or daily use
* History of chronic pain
* Mental or cognitive disorder preventing patient to accurately verbalize pain levels
* Undergoing abdominal or laparoscopic procedures at the time of surgery
* Allergy to hydromorphone
* Surgery is not performed under general anesthesia

Primary outcomes:
measure: Pain While Active - 18 hr
timeFrame: 18 hours
measure: Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Narcotic Associated Side Effects
timeFrame: 24 hours
measure: Time to First Rescue Narcotic
timeFrame: 24 hours
measure: Narcotic Associated Side Effects
timeFrame: 24 hours
measure: Narcotic Associated Side Effects
timeFrame: 24 hours
measure: Narcotic Associated Side Effects
timeFrame: 24 hours
measure: Narcotic Associated Side Effects
timeFrame: 24 hours
measure: Narcotic Associated Side Effects
timeFrame: 24 hours
measure: Narcotic Associated Side Effects
timeFrame: 24 hours
measure: Narcotic Associated Side Effects
timeFrame: 24 hours
measure: Time to Ambulation
timeFrame: 1800 minutes
Other outcomes:
measure: Time to First Flatus/Bowel Movement
timeFrame: 9000 minutes
Locations:
city: Cincinnati
country: United States
facility: TriHealth - Good Samaritan and Bethesda North Hospitals
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Catrina Crisp, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crisp CC, Khan M, Lambers DL, Westermann LB, Mazloomdoost DM, Yeung JJ, Kleeman SD, Pauls RN. The Effect of Intravenous Acetaminophen on Postoperative Pain and Narcotic Consumption After Vaginal Reconstructive Surgery: A Double-Blind Randomized Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):80-85. doi: 10.1097/SPV.0000000000000347.