Status:
COMPLETED
Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,
Lead Sponsor:
Defense and Veterans Center for Integrative Pain Management
Conditions:
Laparoscopic Cholecystectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to learn whether perioperative IV (intravenous) administration of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over the oral (by mo...
Detailed Description
Subjects were enrolled following the listed inclusion and exclusion criteria. Subjects Eligibility Criteria: Inclusion Criteria: Male and female patients ASA I - III . 18 years of age and older Ex...
Eligibility Criteria
Inclusion
- Male and female patients ASA I - III (A system used by anesthesiologists to stratify severity of patients' underlying disease and potential for suffering complications from general anesthesia ), 18 years of age and older
- Patient must be scheduled for laparoscopic cholecystectomy
Exclusion
- Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery
- Chronic home narcotic use (patient-reported narcotic use for greater than 3 months)
- Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery
- Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery
- Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery)
- Prior NSAIDS(Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours
- Use of intraoperative NSAIDs
- Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components;
- On a medication with known interactions with acetaminophen
- On chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day
- Pregnancy
- Current or past alcohol abuse (within the past 2 years)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01823224
Start Date
February 1 2013
End Date
September 1 2015
Last Update
June 6 2016
Active Locations (1)
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1
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310