The Analgesic Effect of Nitroglycerin Patch for Postoperative Pain After Total Knee Replacement
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- pain scores
- morphine use
- sedation score
- nausea and vomiting
| Estimated Enrollment: | 50 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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| Contact: Artium Lenchinsky, MD | 937 6811 |
| Israel | |
| 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 |
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 Postoperative Complications Pathologic Processes Pain Signs and Symptoms Analgesics Nitroglycerin Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Vasodilator Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013