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Preoperative Pain Threshold and Rapid Recover Programs

Primary Purpose

Knee Arthritis, Hip Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wagner Pain Algometer
Dynamometer
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Knee Arthritis focused on measuring Knee Arthroplasty, Hip Arthroplasty

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty
  • Participants of the following investigators will be approached: Bolognesi, Wellman, Attarian, and Seyler

Exclusion Criteria:

  • previous hip or knee surgery in the operative joint

Sites / Locations

  • Duke Medical Plaza Page Road

Outcomes

Primary Outcome Measures

Inpatient length of stay in days
amount of time in hospital
pain control average visual analogue scale 1 - 10 of hospital stay
averaging the subjective pain control
physical therapy performance on the first day after surgery
distance walked in feet on post op day 1
discharge location placement
home, rehab or nursing facility

Secondary Outcome Measures

Outpatient narcotic pill consumption
narcotic equivalents consumed by patient in morphine equivalents. we will convert all medicine to the standard unit
Outpatient narcotic consumption refill needed
need for refill prescription, yes or no
Outpatient narcotic consumption multiple refills needed
number of refills needed requiring provider time outside of scheduled appointment

Full Information

First Posted
March 16, 2016
Last Updated
April 4, 2019
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02740738
Brief Title
Preoperative Pain Threshold and Rapid Recover Programs
Official Title
Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
August 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.
Detailed Description
A minimum of 200 patients, 100 hip and 100 knee arthroplasty participants, will be recruited for this study. Preoperatively, patient pain threshold will be recorded both objectively (Pressure algometer) and subjectively (brief pain inventory). In terms of location, objectively this will be tested during the preoperative visit in clinic by the approved, trained research staff, as well as the subjective brief pain inventory. Objective pain measure: Pressure algometer will be obtained in the standard fashion as follows: the probe is applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds. The participant is instructed by the measurer to say "stop" when the sensation of pressure became the very first sensation of pain. There will be three spots to test patients, one for familiarity of the testing and the other 2 for data collection. This is initially performed once on ipsilateral the tibialis anterior as a "warm up." Then 3 measurements are taken on the operative medial epicondyle (for TKA) or ipsilateral lateral iliac crest (for THA) and averaged for the official score. Lastly, three measurements are also taken on the contralateral olecranon to measure systemic pain sensitivity. If the contralateral elbow has had prior surgery or active bursitis, the ipsilateral elbow will be used. Of important note, the algometer has a max force lock out of 100N to prevent any harm to the patient. Dominant Hand Grip strength measured by the average of 3 attempts on a Dynamometer. Subjectively, the brief pain inventory is a validated pain outcome measure which will be filled out by the participant during their preoperative clinic visit. Postoperative, the study team will ask the participant at the 6 week mark: How many and what kind of opiates did the participant require? How many days did the participant require opiates? Did the participant require a refill? a. If so, did the participant have this filled in clinic preemptively or place a phone call to the office?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis, Hip Arthritis
Keywords
Knee Arthroplasty, Hip Arthroplasty

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Wagner Pain Algometer
Intervention Description
applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds
Intervention Type
Device
Intervention Name(s)
Dynamometer
Intervention Description
Dominant Hand Grip strength measured by the average of 3 attempts
Primary Outcome Measure Information:
Title
Inpatient length of stay in days
Description
amount of time in hospital
Time Frame
1-3 on days average
Title
pain control average visual analogue scale 1 - 10 of hospital stay
Description
averaging the subjective pain control
Time Frame
1-3 days on average
Title
physical therapy performance on the first day after surgery
Description
distance walked in feet on post op day 1
Time Frame
post op day 1
Title
discharge location placement
Description
home, rehab or nursing facility
Time Frame
1 - 3 days on average
Secondary Outcome Measure Information:
Title
Outpatient narcotic pill consumption
Description
narcotic equivalents consumed by patient in morphine equivalents. we will convert all medicine to the standard unit
Time Frame
6-week from surgery
Title
Outpatient narcotic consumption refill needed
Description
need for refill prescription, yes or no
Time Frame
6-week from surgery
Title
Outpatient narcotic consumption multiple refills needed
Description
number of refills needed requiring provider time outside of scheduled appointment
Time Frame
6-week from surgery
Other Pre-specified Outcome Measures:
Title
Complications short term after surgery
Description
Inpatient complications while in the hospital
Time Frame
6-week from surgery
Title
Complications long term after surgery
Description
Outpatient complications seen after discharge
Time Frame
surgery to 1yr postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty Participants of the following investigators will be approached: Bolognesi, Wellman, Attarian, and Seyler Exclusion Criteria: previous hip or knee surgery in the operative joint
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Wellman, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Medical Plaza Page Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Preoperative Pain Threshold and Rapid Recover Programs

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