The Analgesic Effect of Nitroglycerin Patch for Postoperative Pain After Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375362
Recruitment Status : Unknown
Verified July 2006 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : September 13, 2006
Last Update Posted : September 13, 2006
Information provided by:
Rabin Medical Center

Brief Summary:
Patients who undergo general anestheesia for total knee arthroplasty pften have sever postoperative pain which hinders their rehabilitation. Nitroglycerin patches have been found to cause alleviation of pain especially when used in conjuction with morphine. Therefore we propose placement of a nitroglycerin patch after total kneee arthroplasty surgery and see how it affects pain scores or causes less nedd for morphine after surgery.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Drug: Nitroderm patch Not Applicable

Detailed Description:

Patients undergoing total knee arthroplasty will be randomized into two groups: control and placebo.

Eache patient will undergo total knee arthroplasty under general anesthesia. Both groups will get the same anesthetic protocal. At the end of surgery, before awakening patients will recieve either a nitroglycerin or placebo patch on their back. Both the participant and the investigator will be blinded to the group assisignment. At the end of surgery both groups will recieve morphine for postoperative pain. In the recovery room they will be given patient controlled analgesia with morphine. An investigator blinded to study assisignment will record pain scores, sedation scores, nauseau and vomiting. Patients will be given patient controlled analgesia for 24 hours and they will be followed for pain levels, morphine use, sedation and nauseau levels. The nitroderm or placebo patch will be removed after 24 hours.

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of Nitroglycerin Patches for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Study Start Date : July 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Primary Outcome Measures :
  1. pain scores
  2. morphine use
  3. sedation score
  4. nausea and vomiting

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy patients undergoing total knee arthroplasty

Exclusion Criteria:

  • Pshychiatric disorder
  • Allergy to nitroglycerin or morphine
  • Chronic renal failure
  • Migraine headaches
  • Hypotension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375362

Contact: Artium Lenchinsky, MD 937 6811

Rabin Medical Center Recruiting
Petach Tikvah, Israel
Contact: Artium Lenchinsky    937-6811      
Sponsors and Collaborators
Rabin Medical Center
Study Director: Leonid A Eidelman, MD Rabin Medical Center
Principal Investigator: Sharon Orbach-Zinger, MD Rabin Medical Center Identifier: NCT00375362     History of Changes
Other Study ID Numbers: 004083
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: September 13, 2006
Last Verified: July 2006

Keywords provided by Rabin Medical Center:
patient controlled analgesia
total knee arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasodilator Agents