NCT00375362

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
Last Updated

September 13, 2006

Status Verified

July 1, 2006

First QC Date

September 12, 2006

Last Update Submit

September 12, 2006

Conditions

Total Knee Arthroplasty

Keywords

nitroglycerinmorphinepatient controlled analgesiatotal knee arthroplasty

Outcome Measures

Primary Outcomes (4)

  • pain scores

  • morphine use

  • sedation score

  • nausea and vomiting

Interventions

Nitroderm patchDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy patients undergoing total knee arthroplasty

You may not qualify if:

  • Pshychiatric disorder
  • Allergy to nitroglycerin or morphine
  • Chronic renal failure
  • Migraine headaches
  • Hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petach Tikvah, Israel

RECRUITING

Study Officials

  • Leonid A Eidelman, MD

    Rabin Medical Center

    STUDY DIRECTOR

  • Sharon Orbach-Zinger, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Artium Lenchinsky, MD

CONTACT

937 6811

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

July 1, 2006

Study Completion

September 1, 2006

Last Updated

September 13, 2006

Record last verified: 2006-07

Locations

IL(1)