Trial record 5 of 72 for:    Open Studies | "Cholecystectomy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Defense and Veterans Center for Integrative Pain Management
Sponsor:
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier:
NCT01823224
First received: March 29, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Laparoscopic Cholecystectomy
Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"
Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Defense and Veterans Center for Integrative Pain Management:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours after discharge ] [ Designated as safety issue: No ]
    Pain after treatment with IV versus oral tylenol will be assessed via pain scores


Secondary Outcome Measures:
  • Opioid Use [ Time Frame: every 6 hours for 24 hours ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 220
Study Start Date: February 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules "sugar pills" 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg
Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"
Other Name: Acetaminophen is comercially referred to as Tylenol.
Experimental: Group 2
Group 2 will receive an IV "salt water" infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.
Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"
Other Name: Acetaminophen is comercially referred to as Tylenol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01823224

Contacts
Contact: Amy McCoart 910-907-6239 amccoart@dvpmi.org

Locations
United States, North Carolina
Womack Army Medical Center Recruiting
Fort Bragg, North Carolina, United States, 28310
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management
  More Information

No publications provided

Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT01823224     History of Changes
Other Study ID Numbers: 380250
Study First Received: March 29, 2013
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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