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Pain Management After Shoulder Arthroplasty

Primary Purpose

Caffeine, Pain, Joint

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Total Shoulder Arthroplasty
Caffeine Pill
Percocet 10Mg-325Mg Tablet
Zofran 4Mg Tablet
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caffeine

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients who undergo primary Total Shoulder Arthroplasty or Reverse Total Shoulder Arthroplasty
  • Patient willing and able to complete postoperative surveys
  • Post-Menopausal Women and Men over the age of 55

Exclusion Criteria:

  • Patients reporting caffeine consumption in excess of 300mg daily
  • Patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse.
  • Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
  • Patient has a known allergy to aspirin or caffeine.
  • Patient has history of cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including pain.
  • Patient has history of anxiety disorder
  • Patients with known sleep disturbances that would otherwise be affected by caffeine
  • Patients undergoing revision surgery
  • Patients who require alternate DVT prophylaxis other than ASA.
  • Patients undergoing inpatient arthroplasty
  • Workman's comp patient or patient has current litigation pending

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Caffeine Group

No Caffeine Group

Arm Description

2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)

aspirin 325mg + standard pain (control)

Outcomes

Primary Outcome Measures

postoperative shoulder function
This will be measured using the Simple Shoulder Test (SST) which consist of 12 questions
Postoperative shoulder function
This will be measured using the American Shoulder and Elbow Surgeon Survey (ASES)
Postoperative Pain
This will be measured using the Visual Analog Scale for Pain (VAS) survey

Secondary Outcome Measures

Full Information

First Posted
May 3, 2021
Last Updated
May 3, 2021
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04872270
Brief Title
Pain Management After Shoulder Arthroplasty
Official Title
Multimodal Postoperative Pain Management Following Shoulder Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Anticipated)
Study Completion Date
April 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. Current trends in pain management are morphing and multimodal opioid sparing protocols are now being evaluated and implemented, with results showing a decrease in the amount of opioids being prescribed. Despite all efforts, most patients experience pain and, in order to control it, multiple medications have been tried with variable results. The most commonly prescribed medications are opioids, but side effects associated with their use as well as their addictive potential are making them a less desirable option for patients. Currently there is a trend towards diminishing opioids consumption and prescribing alternative pain control regimens.Caffeine is a well known molecule that when associated with non-steroidal anti-inflammatory drugs (NSAIDS) potentiates their analgesic effect and decreases the amount of doses required to control pain. Little is known about the effect of caffeine over pain relief in patients undergoing total joint arthroplasty, but preliminary results in other fields make us believe it could have a potential benefit for patients undergoing total joint arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caffeine, Pain, Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caffeine Group
Arm Type
Active Comparator
Arm Description
2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
Arm Title
No Caffeine Group
Arm Type
Active Comparator
Arm Description
aspirin 325mg + standard pain (control)
Intervention Type
Procedure
Intervention Name(s)
Total Shoulder Arthroplasty
Intervention Description
Participant will have total shoulder replacement
Intervention Type
Drug
Intervention Name(s)
Caffeine Pill
Intervention Description
2 week supply of 1000 mg caffeine given postoperatively as part of the pain regimen
Intervention Type
Drug
Intervention Name(s)
Percocet 10Mg-325Mg Tablet
Intervention Description
given postoperatively as standard post-op pain management
Intervention Type
Drug
Intervention Name(s)
Zofran 4Mg Tablet
Intervention Description
given postoperatively as standard post-op management
Primary Outcome Measure Information:
Title
postoperative shoulder function
Description
This will be measured using the Simple Shoulder Test (SST) which consist of 12 questions
Time Frame
24 weeks
Title
Postoperative shoulder function
Description
This will be measured using the American Shoulder and Elbow Surgeon Survey (ASES)
Time Frame
24 weeks
Title
Postoperative Pain
Description
This will be measured using the Visual Analog Scale for Pain (VAS) survey
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients who undergo primary Total Shoulder Arthroplasty or Reverse Total Shoulder Arthroplasty Patient willing and able to complete postoperative surveys Post-Menopausal Women and Men over the age of 55 Exclusion Criteria: Patients reporting caffeine consumption in excess of 300mg daily Patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse. Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG. Patient has a known allergy to aspirin or caffeine. Patient has history of cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including pain. Patient has history of anxiety disorder Patients with known sleep disturbances that would otherwise be affected by caffeine Patients undergoing revision surgery Patients who require alternate DVT prophylaxis other than ASA. Patients undergoing inpatient arthroplasty Workman's comp patient or patient has current litigation pending
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Pain Management After Shoulder Arthroplasty

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