RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain

Study Overview
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Brief Summary
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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
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see brief summary

Official Title
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The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: IV Acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Acetaminophen<br>Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. | Drug: IV Acetaminophen<br>* Details covered in arm description.<br>* Other names: Ofirmev;|
| Placebo Comparator: Saline<br>Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. | Drug: IV Acetaminophen<br>* Details covered in arm description.<br>* Other names: Ofirmev;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain While Active - 18 hr | Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active. | 18 hours | 
| Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery | Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for nausea/vomiting. | 24 hours | 
| Time to First Rescue Narcotic | The time from the end of surgery to the time any IV narcotic is given. | 24 hours | 
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for itching. | 24 hours | 
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for headache. | 24 hours | 
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for insomnia. | 24 hours | 
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for rash/hives. | 24 hours | 
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for shortness of breath. | 24 hours | 
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for respiratory depression. | 24 hours | 
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for urinary retention. | 24 hours | 
| Time to Ambulation | Length of time from the end of surgery to the time of ambulation. | 1800 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV Acetaminophen, Vaginal Reconstruction, Pain, Postoperative