Total Shoulder Arthroplasty Preoperative Pain Threshold and Association With Postoperative Opioid Consumption

NCT06133933 | Enrolling By Invitation

• 1 other identifier: IRB 21-087
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective research study is to evaluate the effects of preoperative pain threshold using a pressure algometer and its effects on postoperative patient satisfaction, return to work, and opioid consumption following Total Shoulder Arthroplasty (TSA). Participants will have their pain threshold measured at the preoperative visit. Postoperatively, they will be followed for 3 months and complete a pain journal for 2 weeks, record their medications consumed, and complete surveys at 2 weeks, 6 weeks, and 3 months. The study team will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcome.

Conditions

Total Shoulder Arthroplasty; Postoperative Pain; Opioid Use

Keywords

Total Shoulder Arthroplasty; Postoperative Pain; Postoperative Satisfaction; Opioid consumption

Outcome Measures

Primary Outcomes (3)

• Postoperative opioid consumption

  compare preoperative pain threshold with postoperative opioid consumption. The pain threshold will be determined using the pressure algometer/dolorimeter. The term "pain threshold" refers to the measurement of the intensity of a physical stimulus that evokes pain. To estimate the pain threshold, physical force using a mechanical stimulus will be applied with increasing intensity until the patient under evaluation refers to a pain sensation. When the patient declares that the pain is too uncomfortable, the algometer will be removed. This device will quantify the amount of force in pounds that the patient can tolerate. This number is designated as the patient's pain threshold. This value will be correlated with opioid consumption, both by self-reporting and by accessing the Prescription Monitoring Program (PMP). Opioid consumption will be quantified using milligrams of morphine equivalents (MME).

  3 months

• Postoperative satisfaction

  compare preoperative pain threshold with postoperative satisfaction. The pain threshold will be determined using the pressure algometer/dolorimeter. The term "pain threshold" refers to the measurement of the intensity of a physical stimulus that evokes pain. To estimate the pain threshold, physical force using a mechanical stimulus will be applied with increasing intensity until the patient under evaluation refers to a pain sensation. When the patient declares that the pain is too uncomfortable, the algometer will be removed. This device will quantify the amount of force in pounds that the patient can tolerate. This number is designated as the patient's pain threshold. This value will be correlated with patient satisfaction. Patients will be asked how satisfied they are with their pain control. They can answer on a 1-4 scale, with 1 being the lowest satisfaction and 4 being the highest degree of satisfaction.

  3 months

• Postoperative return to work

  compare preoperative pain threshold with postoperative return to work time in days.

  3 months

Study Arms (1)

Study Cohort

Patients will have their preoperative pain threshold measured and complete postoperative pain journal, pill count, VAS, SF-12, SANE, and Satisfaction Survey in addition to the routine standard of care following perioperative management of total shoulder arthroplasty patients.

Device: Pain Threshold using algometer/dolorimeter

Interventions

Pain Threshold using algometer/dolorimeter DEVICE

These patients who consent to participation in the study will receive a preoperative pain threshold measured using a pain algometer/dolorimeter. We will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcomes.

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, non-randomized observational study. There will only be one group, the treatment group, consisting of patients undergoing Total Shoulder Arthroplasty (TSA). We will recruit patients using a screen for patients who meet inclusion criteria in EPIC or recruit patients via physician referral. Inclusion criteria includes all patients over 18 years of age who are undergoing TSA. When an eligible patient is selected, we will first obtain approval to approach from the treating physician. Once approval is received, a co-investigator will approach them over the phone to inform the patient about a study he or she is eligible for or approach them in-person during their visit.

You may qualify if:

• Patients 18 years or older
• Patients who are scheduled to undergo a Total Shoulder Arthroplasty

You may not qualify if:

• Patients younger than 18 years
• Patients who are scheduled to undergo a Total Shoulder Arthroplasty

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (11)

• Yang MMH, Hartley RL, Leung AA, Ronksley PE, Jette N, Casha S, Riva-Cambrin J. Preoperative predictors of poor acute postoperative pain control: a systematic review and meta-analysis. BMJ Open. 2019 Apr 1;9(4):e025091. doi: 10.1136/bmjopen-2018-025091.

  PMID: 30940757 BACKGROUND

• Friedman RJ, Eichinger J, Schoch B, Wright T, Zuckerman J, Flurin PH, Bolch C, Roche C. Preoperative parameters that predict postoperative patient-reported outcome measures and range of motion with anatomic and reverse total shoulder arthroplasty. JSES Open Access. 2019 Nov 18;3(4):266-272. doi: 10.1016/j.jses.2019.09.010. eCollection 2019 Dec.

  PMID: 31891024 BACKGROUND

• Kim MS, Koh IJ, Sung YG, Park DC, Yoon EJ, In Y. Influence of increased pain sensitivity on patient-reported outcomes following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):782-790. doi: 10.1007/s00167-021-06455-5. Epub 2021 Jan 24.

  PMID: 33486560 BACKGROUND

• Palanisami DR, Reddy DA, Huggi V, Rajasekaran RB, Natesan R, Shanmuganathan R. Assessing Preoperative Pain Sensitivity Predicts the Postoperative Analgesic Requirement and Recovery after Total Knee Arthroplasty: A Prospective Study of 178 Patients. J Arthroplasty. 2020 Dec;35(12):3545-3553. doi: 10.1016/j.arth.2020.07.029. Epub 2020 Jul 18.

  PMID: 32773269 BACKGROUND

• Nickel BT, Klement MR, Byrd WA, Attarian DE, Seyler TM, Wellman SS. The James A. Rand Young Investigator's Award: Battling the Opioid Epidemic with Prospective Pain Threshold Measurement. J Arthroplasty. 2018 Jul;33(7S):S3-S7. doi: 10.1016/j.arth.2018.02.060. Epub 2018 Feb 21.

  PMID: 29567001 BACKGROUND

• Shigematsu-Locatelli M, Kawano T, Kitamura S, Nishigaki A, Yamanaka D, Aoyama B, Tateiwa H, Yokoyama M. Does preoperative patient's estimated acceptable pain affect the satisfaction with postoperative pain management? JA Clin Rep. 2017;3(1):5. doi: 10.1186/s40981-016-0075-0. Epub 2017 Jan 10.

  PMID: 29492444 BACKGROUND

• Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.

  PMID: 22506152 BACKGROUND

• Buchanan HM, Midgley JA. Evaluation of pain threshold using a simple pressure algometer. Clin Rheumatol. 1987 Dec;6(4):510-7. doi: 10.1007/BF02330587.

  PMID: 3449302 BACKGROUND

• Chesterton LS, Sim J, Wright CC, Foster NE. Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters. Clin J Pain. 2007 Nov-Dec;23(9):760-6. doi: 10.1097/AJP.0b013e318154b6ae.

  PMID: 18075402 BACKGROUND

• Hinarejos P, Goicoechea N, Gidi M, Leal-Blanquet J, Torres-Claramunt R, Sanchez-Soler J, Monllau JC. Pressure algometry is a suitable tool to assess anterior knee pain in osteoarthritic patients. Eur J Orthop Surg Traumatol. 2019 Jul;29(5):1089-1093. doi: 10.1007/s00590-019-02391-w. Epub 2019 Feb 7.

  PMID: 30734099 BACKGROUND

• Sayed-Noor AS, Englund E, Wretenberg P, Sjoden GO. Pressure-pain threshold algometric measurement in patients with greater trochanteric pain after total hip arthroplasty. Clin J Pain. 2008 Mar-Apr;24(3):232-6. doi: 10.1097/AJP.0b013e3181602159.

  PMID: 18287829 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Catherine J Fedorka, MD

  Cooper University Hospital Department of Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Assistant Professor of Orthopaedic Surgery, Assistant Program Director, Orthopaedic Surgery Residency Program

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: November 18, 2023
• Study Start: May 21, 2021
• Primary Completion (Estimated): May 21, 2026
• Study Completion (Estimated): May 21, 2027
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)