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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00375362
Other study ID # 004083
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2006
Last updated September 12, 2006
Start date July 2006
Est. completion date September 2006

Study information

Verified date July 2006
Source Rabin Medical Center
Contact Artium Lenchinsky, MD
Phone 937 6811
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Healthy patients undergoing total knee arthroplasty

Exclusion Criteria:

- Pshychiatric disorder

- Allergy to nitroglycerin or morphine

- Chronic renal failure

- Migraine headaches

- Hypotension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nitroderm patch


Locations

Country Name City State
Israel Rabin Medical Center Petach Tikvah

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain scores
Primary morphine use
Primary sedation score
Primary nausea and vomiting
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