The Analgesic Effect of Nitroglycerin Patch for Postoperative Pain After Total Knee Replacement
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Analgesic Efficacy of Nitroglycerin Patches for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty|
- pain scores
- morphine use
- sedation score
- nausea and vomiting
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||September 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375362
|Contact: Artium Lenchinsky, MD||937 6811|
|Rabin Medical Center||Recruiting|
|Petach Tikvah, Israel|
|Contact: Artium Lenchinsky 937-6811|
|Study Director:||Leonid A Eidelman, MD||Rabin Medical Center|
|Principal Investigator:||Sharon Orbach-Zinger, MD||Rabin Medical Center|