Preoperative Pain Threshold and Rapid Recover Programs

Knee Arthritis Clinical Trial

Official title:

Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740738
• Other study ID #: Pro00069521
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 6, 2018

Study information

• Verified date: April 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.

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.

1. This is initially performed once on ipsilateral the tibialis anterior as a "warm up."

2. 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.

3. 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.

4. 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:

1. How many and what kind of opiates did the participant require?

2. How many days did the participant require opiates?

3. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 6, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Knee Arthritis

Intervention

Device:
• Wagner Pain Algometer
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
• Dynamometer
Dominant Hand Grip strength measured by the average of 3 attempts

Locations

Country	Name	City	State
United States	Duke Medical Plaza Page Road	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications short term after surgery	Inpatient complications while in the hospital	6-week from surgery
Other	Complications long term after surgery	Outpatient complications seen after discharge	surgery to 1yr postoperative
Primary	Inpatient length of stay in days	amount of time in hospital	1-3 on days average
Primary	pain control average visual analogue scale 1 - 10 of hospital stay	averaging the subjective pain control	1-3 days on average
Primary	physical therapy performance on the first day after surgery	distance walked in feet on post op day 1	post op day 1
Primary	discharge location placement	home, rehab or nursing facility	1 - 3 days on average
Secondary	Outpatient narcotic pill consumption	narcotic equivalents consumed by patient in morphine equivalents. we will convert all medicine to the standard unit	6-week from surgery
Secondary	Outpatient narcotic consumption refill needed	need for refill prescription, yes or no	6-week from surgery
Secondary	Outpatient narcotic consumption multiple refills needed	number of refills needed requiring provider time outside of scheduled appointment	6-week from surgery