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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00375362
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 24.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jul 1, 2006
• Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. pain scores []

2. morphine use []

3. sedation score []

4. nausea and vomiting []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petach Tikvah		Israel

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00375362
• Other Study ID Numbers: 004083
• First Posted: Sep 13, 2006
• Last Update Posted: Sep 13, 2006
• Last Verified: Jul 1, 2006

• Keywords provided by , ,: nitroglycerin; morphine; patient controlled analgesia; total knee arthroplasty
• Additional relevant MeSH terms: Pain, Postoperative; Nitroglycerin

Study Results

No Results Posted as of Sep 13, 2006