Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375362
Status:
UNKNOWN
Last Update Posted:
2006-09-13
First Post:
2006-09-12
Brief Title:
The Analgesic Effect of Nitroglycerin Patch for Postoperative Pain After Total Knee Replacement
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
The Analgesic Efficacy of Nitroglycerin Patches for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None