A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01823224
• Other study ID #: 380250
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2013
• Last updated: December 31, 2014
• Start date: February 2013

Study information

• Verified date: May 2014
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: Amy McCoart
• Phone: 910-907-6239
• Email: amccoart[@]dvpmi.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 mouth) administration of acetaminophen for a patient having a laparoscopic cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen, it may result in fewer requests for pain-related intervention such as other oral pain medications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• 2 capsules Oral Tylenol 2000 mg and IV "salt water"

• IV tylenol 1000mg and 2 oral capsule "sugar pills"

Locations

Country	Name	City	State
United States	Womack Army Medical Center	Fort Bragg	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain after treatment with IV versus oral tylenol will be assessed via pain scores	24 hours after discharge	No
Secondary	Opioid Use	Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded: Opioid consumption from first waking to T4; Total opioid consumption from T0 to T4; Total opioid consumption from time of first waking to T24; Time to first use of rescue medication	every 6 hours for 24 hours	No