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The Analgesic Effect of Nitroglycerin Patch for Postoperative Pain After Total Knee Replacement

NCT ID: NCT00375362

Last Updated: 2006-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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Total Knee Arthroplasty

Keywords

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nitroglycerin morphine patient controlled analgesia total knee arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nitroderm patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy patients undergoing total knee arthroplasty

Exclusion Criteria

* Pshychiatric disorder
* Allergy to nitroglycerin or morphine
* Chronic renal failure
* Migraine headaches
* Hypotension
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Leonid A Eidelman, MD

Role: STUDY_DIRECTOR

Rabin Medical Center

Sharon Orbach-Zinger, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Rabin Medical Center

Petach Tikvah, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Artium Lenchinsky, MD

Role: CONTACT

Phone: 937 6811

Facility Contacts

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Artium Lenchinsky

Role: primary

Other Identifiers

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004083

Identifier Type: -

Identifier Source: org_study_id