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Completed

NCT Number: NCT04294680

Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campbell Clinic

Memphis, Tennessee, 38138, United States

About this study

This is a single center, investigator initiated, prospective, randomized, controlled trial conducted among patients who have given voluntary consent to participate. Participation will last until the completion of the twelve weeks standard of care follow up visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary shoulder arthroplasty
  • 18-85 years of age
  • Body Mass Index greater than or equal to 45
  • Willing and able to provide written informed consent
  • Willing and able to cooperative in the required postoperative therapy
  • Willing and able to complete scheduled follow-up evaluations
  • Fluent in verbal and written English

Exclusion criteria

  • Less than 18 years or over 85 years of age
  • Unable to provide written informed consent, cooperate with postoperative therapy, or complete follow-up evaluations
  • Known sensitivity, allergy, or intolerance to medications with protocols
  • Renal disease as defined by active or impending dialysis within six months or kidney transplant
  • Concomitant ipsilateral upper extremity injury or condition other than shoulder that compromises function
  • Chronic pain syndrome
  • Five consecutive days of opiate use with the previous ninety days
  • Worker's compensation claim
  • Women who are pregnant, planning to become to become pregnant, or breastfeeding

Treatment and study plan

Cryotherapy

Device

see opiate sparing description

Primary outcomes

  1. Visual Analog Score (VAS) at Week 2

    Time frame: postoperative day fourteen (two weeks)

    The Visual Analog Score (VAS) is a a validated patient reported pain score with possible range from zero (no pain) to ten (worst possible pain).

Secondary outcomes

  1. Number of Opioid Pain Pills Taken

    Time frame: Post-operative Day 1 through 12 weeks

    The total number of opioid pain pills consumed from post-operative day 1 to Week 12

Sponsors and collaborators

Lead sponsor

Campbell Clinic

Other

Registry information

Official study title

Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate-Based Protocol Following Shoulder Arthroplasty

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2020
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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