RCT of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by TriHealth Inc.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT02043704
First received: January 21, 2014
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Post Operative Pain
Drug: IV Acetaminophen
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

see brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043704

Contacts
Contact: Catrina Crisp, MD, MSc 513-819-0798 catrina_crisp@trihealth.com
Contact: Madiha Khan, MD 513-819-0005 madiha_khan@trihealth.com

Locations
United States, Ohio
TriHealth - Good Samaritan and Bethesda North Hospitals Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Michaela Eschenbacher, MPH    513-862-2341    michaela_eschenbacher@trihealth.com   
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Catrina Crisp, MD, MSc TriHealth Inc.
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02043704     History of Changes
Other Study ID Numbers: 13072
Study First Received: January 21, 2014
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
IV Acetaminophen
Vaginal Reconstruction
Pain, Postoperative

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 16, 2014