Clinical trial NCT02740738: Preoperative Pain Threshold and Rapid Recover Programs
Official title: Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthritis
Hip Arthritis
Keywords: Knee Arthroplasty
Hip Arthroplasty
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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?

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

Primary outcomes:
measure: Inpatient length of stay in days
timeFrame: 1-3 on days average
measure: pain control average visual analogue scale 1 - 10 of hospital stay
timeFrame: 1-3 days on average
measure: physical therapy performance on the first day after surgery
timeFrame: post op day 1
measure: discharge location placement
timeFrame: 1 - 3 days on average
Secondary outcomes:
measure: Outpatient narcotic pill consumption
timeFrame: 6-week from surgery
measure: Outpatient narcotic consumption refill needed
timeFrame: 6-week from surgery
measure: Outpatient narcotic consumption multiple refills needed
timeFrame: 6-week from surgery
Other outcomes:
measure: Complications short term after surgery
timeFrame: 6-week from surgery
measure: Complications long term after surgery
timeFrame: surgery to 1yr postoperative
Locations:
city: Durham
country: United States
facility: Duke Medical Plaza Page Road
state: North Carolina
Study officials:
affiliation: Duke University
name: Samuel Wellman, MD
role: PRINCIPAL_INVESTIGATOR
References: