Post-Operative Pain Control Following Shoulder Surgery

NCT04622839 | Completed DMC

• 1 other identifier: IRB00248454
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate overall opioid and non-narcotic analgesic use following surgical treatment for shoulder pathology, and recommend evidence based guidelines for standardized postoperative pain management.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (3)

• Morphine milligram equivalents (MMEs) consumed

  Total possible narcotic pain medication use in MME's

  2 weeks postop

• Opioid Prescription Refills

  number and quantity of opioid prescription refills

  2 weeks postop

• Office Contacts

  Number of times patient contacted the office via telephone, MyChart, or email

  2 weeks postop

Secondary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) score

  2-4 months postop

Study Arms (3)

Group 1

EXPERIMENTAL

Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc.

Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)

Group 2

EXPERIMENTAL

Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc.

Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)

Group 3

EXPERIMENTAL

Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc.

Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)

Interventions

Tylenol and NSAIDS (Ibuprofen, diclofenac) OTHER

This study will assess an aspect of perioperative care relating to pain control. Subjects will not be aware of which aspect is randomized, but will be given a list of possible aspects which will include the intervention (listed below): * Agents used in nerve block (lidocaine vs ropivacaine) * Location of injection for analgesic * Use of over-the-counter pain management (including but not limited to acetaminophen, ibuprofen, naproxen, etc.) * Type of initial opioid prescribed (including but not limited to oxycodone, tramadol, hydrocodone, etc.) * Number of pills in the initial opioid prescription * Instructions for sling wear (duration of use or type of sling) * Ice usage (duration of use and frequency of use) Blinding the participant to the randomized aspect of this study will help prevent bias in patient responses for outcome scores and medication usage.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Opioid-naive adults age 18-90 years old planning to undergo surgical treatment for shoulder pathology with the PI at Johns Hopkins Shoulder Service (Columbia, Odenton clinic sites; Howard County General Hospital/Johns Hopkins Hospital operative sites) will be included.

You may not qualify if:

• Patients with prior history of opioid misuse, addiction, or chronic pain
• Patients taking chronic pain medication or have taken opioid medication in the past 3 months will be excluded due to risk of developing drug tolerances that could affect the amount of pain medication consumed after surgery An exception will be made for those who have used narcotic medication for fracture-related events, and expect to undergo surgical treatment for fracture repair (ORIF or arthroplasty)
• Patients with BMI \< 18.5 or \> 39.9
• Patients with a history of adverse reaction and/or allergy to oxycodone
• Patients lacking the ability to consent will also be excluded.
• Patients whose primary residence is outside the United States will be excluded.
• Patients who are unable to complete questionnaires due to medical condition, psychiatric illness, or significant language barrier will also be excluded.

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Shoulder and Elbow Surgeons: collaborator

Study Sites (1)

Howard County General Hospital

Columbia, Maryland, 21045, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen; Diclofenac

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Phenylacetates

Study Officials

• Umasuthan Srikumaran, M.D.

  Johns Hopkins Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participants will be masked to the aspect of post-operative pain management being manipulated in this study; investigator and outcomes assessor will be masked to randomization (group assignment) of participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants undergoing shoulder surgery will be randomized into one of the three study arms.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 10, 2020
• Study Start: December 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 16, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)