Post-Operative Pain Control Following Shoulder Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
There is currently very limited information in the literature regarding postoperative pain medication consumption following orthopedic shoulder surgery. To fill this knowledge gap, this study will evaluate overall opioid consumption in morphine milligram equivalents and non-narcotic analgesic use following surgical treatment for shoulder pathology.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 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)
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.
|
| Experimental: Group 2 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)
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.
|
| Experimental: Group 3 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)
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.
|
Outcome Measures
Primary Outcome Measures
- Morphine milligram equivalents (MMEs) consumed [24 hours postop]
Total narcotic pain medication use in MME's
- Morphine milligram equivalents (MMEs) consumed [48 hours postop]
Total narcotic pain medication use in MME's
- Morphine milligram equivalents (MMEs) consumed [72 hours postop]
Total narcotic pain medication use in MME's
- Morphine milligram equivalents (MMEs) consumed [7-14 days postop]
Total narcotic pain medication use in MME's
- Morphine milligram equivalents (MMEs) consumed [4-6 weeks postop]
Total narcotic pain medication use in MME's
- Morphine milligram equivalents (MMEs) consumed [10-14 weeks postop]
Total narcotic pain medication use in MME's
- Numeric Pain Rating Scale [24 hours post op]
0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
- Numeric Pain Rating Scale [48 hours post op]
0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
- Numeric Pain Rating Scale [72 hours post op]
0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
- Numeric Pain Rating Scale [7-14 days post-op]
0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
- Numeric Pain Rating Scale [4-6 weeks post-op]
0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
- Numeric Pain Rating Scale [10-14 weeks post-op]
0-10 pain rating scale; outcome measure that reflects intensity of pain with a higher value integer representing more intense pain (10 - worst pain).
- Length of time to stop opioid use [Up to 14 weeks postop]
Length of time (days) to completely stop opioid use after surgery.
- Amount of unused opioid medication in MMEs [Up to 14 weeks postop]
Total amount of MMEs leftover from post-operative pain prescriptions after stopping opioid use.
- Number of medication refill requests [Up to 14 weeks postop]
Total number of calls or electronic requests by participant requesting additional pain medication.
- Knowledge of opioid storage and disposal [Up to 14 weeks postop]
Knowledge and practice of safe opioid storage and disposal procedures as assessed by a 6-item questionnaire
- Patient satisfaction with postoperative pain management [24 hours post-op]
0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
- Patient satisfaction with postoperative pain management [48 hours post-op]
0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
- Patient satisfaction with postoperative pain management [72 hours post-op]
0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
- Patient satisfaction with postoperative pain management [7-14 days post-op]
0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
- Patient satisfaction with postoperative pain management [4-6 weeks post-op]
0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
- Patient satisfaction with postoperative pain management [10-14 weeks post-op]
0-10 numeric rating scale of satisfaction with postoperative pain management; with 10 representing highest satisfaction
- Non-medication analgesic methods [24 hours post-op]
6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
- Non-medication analgesic methods [48 hours post-op]
6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
- Non-medication analgesic methods [72 hours post-op]
6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
- Non-medication analgesic methods [7-14 hours post-op]
6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
- Non-medication analgesic methods [4-6 weeks post-op]
6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
- Non-medication analgesic methods [10-14 weeks post-op]
6-item descriptive questionnaire (not scored) to analyze type, frequency, and duration of non-medication analgesic methods including but not limited to ice/cryotherapy, sling, etc.
Secondary Outcome Measures
- American Shoulder and Elbow Surgeons (ASES) score [7-14 days postop]
standardized questionnaire for the assessment of shoulder function; single score which ranges from 0-100 with higher score reflecting higher function
- American Shoulder and Elbow Surgeons (ASES) score [10-14 weeks postop]
standardized questionnaire for the assessment of shoulder function; single score which ranges from 0-100 with higher score reflecting higher function
- Comprehensive Shoulder Assessment score [7-14 days postop]
6 item questionnaire to asses shoulder-specific quality-of-life; score range 0-100 with higher score reflecting higher shoulder-specific quality-of-life
- Comprehensive Shoulder Assessment score [10-14 weeks postop]
6 item questionnaire to asses shoulder-specific quality-of-life; score range 0-100 with higher score reflecting higher shoulder-specific quality-of-life
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Howard County General Hospital | Columbia | Maryland | United States | 21045 |
Sponsors and Collaborators
- Johns Hopkins University
- American Shoulder and Elbow Surgeons
Investigators
- Principal Investigator: Umasuthan Srikumaran, M.D., Johns Hopkins Orthopedics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00248454