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IV Acetaminophen Effects on Hyperalgesia After Cardiac Surgery (CarDolMev)

This study is currently recruiting participants.
Verified July 2012 by University of Washington
Sponsor:
Collaborator:
Cadence Pharmaceuticals
Information provided by (Responsible Party):
Philippe Richebe, University of Washington
ClinicalTrials.gov Identifier:
NCT01544062
First received: February 28, 2012
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

Coronary artery bypass grafting (CABG) is one of the most commonly performed major surgical procedures with around 160,000 CABG procedures performed in 2010 in the United States. Despite the decreasing mortality and morbidity associated with CABG, pain that persists after the sternotomy remains often unrecognized, but significant clinical problem. The prevalence of chronic post-sternotomy pain (PSP) ranges from 11 to 56% and approaches limb amputation and thoracotomy as the surgeries with highest risk of chronic post-surgical pain (CPSP) development.

Post-operative acute pain and analgesic consumption appear to be associated with the development of chronic PSP. The amount of secondary hyperalgesia surrounding the surgical incision also contributes to the amount of post-operative acute pain. Prior studies have suggested a possible link between post-operative hyperalgesia and the risk of CPSP. Therefore, there is a need to optimize the treatment of post-operative acute pain and reduce the amount of secondary hyperalgesia since these interventions could lead to reduced incidence of CPSP.

The addition of intravenous acetaminophen to analgesic regimen in cardiac surgery patients represents a new strategy to decrease post-operative acute pain and central sensitization (i.e., hyperalgesia), which in turn may lead to reduced risk of chronic pain after cardiac surgery.

The investigators study is designed as a prospective, randomized, double-blind placebo-controlled trial to evaluate the effects of adding intravenous acetaminophen versus placebo to standard opioid analgesia regimen on post-operative 24-hour opioid consumption in cardiac surgery patients. Our secondary aims include the evaluation of intravenous acetaminophen effectiveness in reducing secondary or dynamic hyperalgesia, acute surgical and non-surgical pain and development of chronic PSP.


Condition Intervention Phase
Pain
Chronic Pain
 Drug: iv acetaminophen 1g
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Compare the Effectiveness of Perioperative IV Acetaminophen in Reducing Post-Operative Pain and Hyperalgesia After Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Consumption of hydromorphone PCA in mg at 24hs after cardiac surgery [ Time Frame: 24h after cardiac surgery ] [ Designated as safety issue: No ]
    Consumption of iv hydromorphone will be read on the PCA pump the patient will use postoperatively


Secondary Outcome Measures:
  • Pain scores [ Time Frame: Every 6 hours for 48hs ] [ Designated as safety issue: No ]
    VAS, NRS scores

  • Hyperalgesia area [ Time Frame: 24, 48h ] [ Designated as safety issue: No ]
    Mesure of hyperalgesia area around the sternotomy wound with von Frey filament 180g of pressure

  • Hydromorphone consuption in mg [ Time Frame: 48h ] [ Designated as safety issue: No ]
    Read on PCA pump

  • Intraoperative pain level [ Time Frame: During Anesthesia ] [ Designated as safety issue: No ]
    The physiodoloris device (giving to the anesthesia team a ANI index which is a measure of intraoperative pain)will be used during anesthesia. It will not be used to guide intraoperative analgesic administration. ANI index values will just be recorded and analyzed after surgery between the 2 groups.

  • Side effects of opioids [ Time Frame: 24, 48, 72h ] [ Designated as safety issue: Yes ]
    post-operative nausea and vomiting (PONV), pruritus, constipation, urinary retention, dizziness, sedation, respiratory depression and de-ambulation. Scale 0-1-2-3-4 will be used.

  • Chronic pain and rehabilitation at 6 months after surgery [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    6 months post-surgery by phone with the 40-item Quality of Recovery (QoR-40) Questionnaire and the Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2)


Estimated Enrollment: 70
Study Start Date: July 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iv acetaminophen
This group will receive iv acetaminophen 1g at the induction of anesthesia, then iv acetaminophen 1g at the end of surgery. Then 1g iv acetaminophen Q6h until postoperative H24
 Drug: iv acetaminophen 1g
1g iv acetaminophen given at induction of anesthesia for cardiac surgery for the 1st dose. Then, 1g iv given end of surgery, then 1g Q6hs until H24
Placebo Comparator: Saline
At the same timing as for the injection of the experimental drug in the iv acetaminophen group, we will inject the same volum of saline. Bags of iv acetaminophen or saline will be prepared and blinded by the pharmacy of our hospital.
 Drug: iv acetaminophen 1g
1g iv acetaminophen given at induction of anesthesia for cardiac surgery for the 1st dose. Then, 1g iv given end of surgery, then 1g Q6hs until H24

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) subjects who clinically consented to elective sternotomy for CABG, heart valve repair or replacement under general anesthesia, and (2) ages between 18 and 75 years

Exclusion Criteria:

  • (1) subject refusal, (2) non-English speaking, (3) previous chronic or neuropathic pain, (4) previous chronic use of opioids, (5) history of psychiatric disorder, (6) allergy to acetaminophen, (7) severely impaired liver and kidney function and (8) previous sternotomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544062

Contacts
Contact: Philippe RICHEBE, MD PhD 2066163348 prichebe@uw.edu
Contact: Srdjan Jelacic, MD 2065402811 sjelacic@uw.edu

Locations
United States, Washington
University of Washington Medical Center, Department of ANesthesiology and Pain Medicine Recruiting
Seattle, Washington, United States, 98195
Contact: Philippe Richebe, MD PhD     206-616-3348     prichebe@uw.edu    
Sub-Investigator: Srdjan Jelacic, MD            
Sub-Investigator: Cyril Rivat, PhD            
Sub-Investigator: Peter Von Homeyer, MD            
Sub-Investigator: Eliot Fagley, MD            
Sub-Investigator: Kei Togashi, MD            
Sub-Investigator: Gabriel Aldea, MD            
Sub-Investigator: Jack Sun, MD            
Sponsors and Collaborators
University of Washington
Cadence Pharmaceuticals
Investigators
Study Director: Lisa Flint, BS University of Washington
Principal Investigator: Philippe Richebe, MD PhD University of Washington
  More Information

No publications provided

Responsible Party: Philippe Richebe, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01544062     History of Changes
Other Study ID Numbers: 42204-D
Study First Received: February 28, 2012
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Cardiac surgery
Pain
Hyperalgesia
 IV acetaminophen
outcomes
chronic pain

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Antipyretics
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013