RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial|
- Post Operative Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Post operative pain will be assessed 18 and 24 hours after surgery and immediately prior to discharge. Pain will be self reported by patients using a 10cm visual analog scale (VAS). At each time point a pain score will be collected for pain at rest and pain with ambulation or an action symbolizing ambulation (i.e. coughing).
- Total amount of narcotic consumption in the first 24 hours post surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.
- Narcotic associated side effects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The incidence of known narcotic associated side effects will be recorded, including: nausea, emesis, itching, headache, insomnia, rash/hives, shortness of breath, respiratory depression, and urinary retention.
- Time to first rescue narcotic [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The time from the end of surgery to the time any IV narcotic is given.
- Time to ambulation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Length of time from the end of surgery to the time of ambulation.
- Time to first flatus/bowel movement [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Length of time from the end of surgery to the time of first flatus or bowel movement.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: IV Acetaminophen
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
Details covered in arm description.
Other Name: Ofirmev
Placebo Comparator: Saline
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02043704
|Contact: Catrina Crisp, MD, MScemail@example.com|
|Contact: Madiha Khan, MDfirstname.lastname@example.org|
|United States, Ohio|
|TriHealth - Good Samaritan and Bethesda North Hospitals||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Michaela Eschenbacher, MPH 513-862-2341 email@example.com|
|Principal Investigator:||Catrina Crisp, MD, MSc||TriHealth Inc.|