Preoperative Pain Threshold and Rapid Recover Programs

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02740738
• Collaborator: (none)
• Enrollment: 201
• Location: 1
• Duration (Months): 29.2
• Patients Per Site Per Month: 6.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthritis; Hip Arthritis	Device: Wagner Pain Algometer; Device: Dynamometer	N/A

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?

Study Design

• Study Type: Interventional
• Actual Enrollment: 201 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Preoperative Pain Threshold and Rapid Recover Programs in Total Joint Arthroplasty
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Aug 6, 2018

Outcome Measures

Primary Outcome Measures

1. Inpatient length of stay in days [1-3 on days average]

   amount of time in hospital

2. pain control average visual analogue scale 1 - 10 of hospital stay [1-3 days on average]

   averaging the subjective pain control

3. physical therapy performance on the first day after surgery [post op day 1]

   distance walked in feet on post op day 1

4. discharge location placement [1 - 3 days on average]

   home, rehab or nursing facility

Secondary Outcome Measures

1. Outpatient narcotic pill consumption [6-week from surgery]

   narcotic equivalents consumed by patient in morphine equivalents. we will convert all medicine to the standard unit

2. Outpatient narcotic consumption refill needed [6-week from surgery]

   need for refill prescription, yes or no

3. Outpatient narcotic consumption multiple refills needed [6-week from surgery]

   number of refills needed requiring provider time outside of scheduled appointment

Other Outcome Measures

1. Complications short term after surgery [6-week from surgery]

   Inpatient complications while in the hospital

2. Complications long term after surgery [surgery to 1yr postoperative]

   Outpatient complications seen after discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Medical Plaza Page Road	Durham	North Carolina	United States	27703

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Samuel Wellman, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02740738
• Other Study ID Numbers: Pro00069521
• First Posted: Apr 15, 2016
• Last Update Posted: Apr 8, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: Knee Arthroplasty; Hip Arthroplasty
• Additional relevant MeSH terms: Arthritis

Study Results

No Results Posted as of Apr 8, 2019