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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00375362
First received: September 12, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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 Intervention
Total Knee Arthroplasty
Drug: Nitroderm patch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of Nitroglycerin Patches for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • pain scores
  • morphine use
  • sedation score
  • nausea and vomiting

Estimated Enrollment: 50
Study Start Date: July 2006
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy patients undergoing total knee arthroplasty

Exclusion Criteria:

  • Pshychiatric disorder
  • Allergy to nitroglycerin or morphine
  • Chronic renal failure
  • Migraine headaches
  • Hypotension
  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: NCT00375362

Contacts
Contact: Artium Lenchinsky, MD 937 6811

Locations
Israel
Rabin Medical Center Recruiting
Petach Tikvah, Israel
Contact: Artium Lenchinsky    937-6811      
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Leonid A Eidelman, MD Rabin Medical Center
Principal Investigator: Sharon Orbach-Zinger, MD Rabin Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375362     History of Changes
Other Study ID Numbers: 004083
Study First Received: September 12, 2006
Last Updated: September 12, 2006
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Analgesics
Nitroglycerin
Cardiovascular Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014