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

Total Knee Arthroplasty Clinical Trial

Official title:

The Analgesic Efficacy of Nitroglycerin Patches for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00375362
• Other study ID #: 004083
• 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
• 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

• Pain, Postoperative
• Total Knee Arthroplasty

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