Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307853
Status:
TERMINATED
Last Update Posted:
2009-10-20
First Post:
2006-03-27
Brief Title:
TRAUMEEL for Pain After Total KneeHip Arthroplasty
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
A Randomised Double - Blind Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Pain After Total Knee and Total Hip Arthroplasty
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty
224 patients meeting all inclusion and none of exclusion criteria will be enrolled in the trial Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection normal saline and indistinguishable oral placebo tablets Baseline measurements of relevant outcome measures will taken preoperatively
In the recovery room the patient will begin to receive IV Dipyrone Optalgin 1000mg for a total of 4 doses during the first 24 hours postoperatively 1000 mg every 6 hours Once back in the ward the patient will be connected to an IV Patient-Controlled Analgesia PCA device enabling the self-administration of morphine at a set dose of 1mg every 8 minutes should the patient require it The PCA memory registers the time and dose and the data will be used later to evaluate post-operative pain
224 patients meeting all inclusion and none of exclusion criteria will be enrolled in the trial Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection normal saline and indistinguishable oral placebo tablets Baseline measurements of relevant outcome measures will taken preoperatively
In the recovery room the patient will begin to receive IV Dipyrone Optalgin 1000mg for a total of 4 doses during the first 24 hours postoperatively 1000 mg every 6 hours Once back in the ward the patient will be connected to an IV Patient-Controlled Analgesia PCA device enabling the self-administration of morphine at a set dose of 1mg every 8 minutes should the patient require it The PCA memory registers the time and dose and the data will be used later to evaluate post-operative pain
Detailed Description:
None
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