RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
March 14, 2018
CompletedAugust 16, 2018
February 1, 2018
2.6 years
January 21, 2014
October 11, 2017
July 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
Narcotic Associated Side Effects
24 hours
Time to First Rescue Narcotic
24 hours
Narcotic Associated Side Effects
24 hours
Narcotic Associated Side Effects
24 hours
Narcotic Associated Side Effects
24 hours
- +5 more secondary outcomes
Other Outcomes (1)
Time to First Flatus/Bowel Movement
9000 minutes
Study Arms (2)
IV Acetaminophen
EXPERIMENTALSubjects 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.
Saline
PLACEBO COMPARATORSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriHealth Inc.lead
Study Sites (1)
TriHealth - Good Samaritan and Bethesda North Hospitals
Cincinnati, Ohio, 45220, United States
Related Publications (1)
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.
PMID: 28230615DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Specialist
- Organization
- TriHealth
Study Officials
- PRINCIPAL INVESTIGATOR
Catrina Crisp, MD, MSc
TriHealth Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2014
First Posted
January 23, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 16, 2018
Results First Posted
March 14, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share