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

Primary Purpose

Total Knee Arthroplasty

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nitroderm patch
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring nitroglycerin, morphine, patient controlled analgesia, total knee arthroplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy patients undergoing total knee arthroplasty

Exclusion Criteria:

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

Sites / Locations

  • Rabin Medical CenterRecruiting

Outcomes

Primary Outcome Measures

pain scores
morphine use
sedation score
nausea and vomiting

Secondary Outcome Measures

Full Information

First Posted
September 12, 2006
Last Updated
September 12, 2006
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00375362
Brief Title
The Analgesic Effect of Nitroglycerin Patch for Postoperative Pain After Total Knee Replacement
Official Title
The Analgesic Efficacy of Nitroglycerin Patches for Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty
Keywords
nitroglycerin, morphine, patient controlled analgesia, total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nitroderm patch
Primary Outcome Measure Information:
Title
pain scores
Title
morphine use
Title
sedation score
Title
nausea and vomiting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy patients undergoing total knee arthroplasty Exclusion Criteria: Pshychiatric disorder Allergy to nitroglycerin or morphine Chronic renal failure Migraine headaches Hypotension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Artium Lenchinsky, MD
Phone
937 6811
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid A Eidelman, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sharon Orbach-Zinger, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikvah
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artium Lenchinsky
Phone
937-6811

12. IPD Sharing Statement

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

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