Interscalene Block, Rebound Pain, Shoulder Arthroplasty
Conditions
Keywords
local anesthetics, rebound pain, brachial plexus, shoulder arthroscopy
Brief summary
Randomized control study that compares different concentrations of local anesthetic to investigate whether a lower concentration of local anesthetic would contribute to lower rebound pain scores at 24 hours post op in patients undergoing anatomic or reverse total shoulder arthroplasty.
Interventions
DRUGBupivacaine
We are comparing two concentrations of the same drug: 10 ml of 0.5% and 20 ml of 0.25%; We will use the same milligram dose (50 mg).
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
randomized control study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Total shoulder replacement patients (anatomic and reverse) * Adult patients (greater than or equal to 18 years) * Any gender * Any race
Exclusion criteria
* \- Chronic Pain diagnoses including: * substance/opioid use disorder * complex regional pain syndromes * fibromyalgia * Daily persistent opioid use spanning 3 months prior to surgery date * Allergy to local anesthetics or NSAIDS * Respiratory pathologies including: * CPAP- non-compliant / untreated obstructive sleep apnea * COPD * Restrictive lung disease (pulmonary fibrosis, interstitial pneumonia, etc) * Contralateral diaphragm dysfunction * BMI \> 40 * Ipsilateral extremity pre-existing nerve injury * GFR \< 60 * NSAID contraindications * Inability to follow up * Revision surgery * Patients requesting block as primary (avoidance of general anesthesia) * Need or request for brachial plexus catheter or liposomal bupivacaine * Vulnerable populations (pregnancy, incarceration, etc) * non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Max NRS Pain Score at 24 hours | 24 hours after intervention | Pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qor15 score questionnaire. | 24, 48 and 72 hours. | Patient will answer QoR15 questionnaire |
| Lowest NRS pain score | 24, 48, 72 hours | Lowest pain intensity measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain. |
| Opioid Use | Assessed at 72 hours | Total doses used will be converted to Morphine Milligram Equivalents |
| Sensory Block Duration | Assessed at 24 hours. | The Investigator will ask the patient how long they felt the nerve block was effective, in terms of hours. |
| Presence of dyspnea/shortness of breath | Assessed at 24 hours. | The investigator will ask the patient if they ever had trouble breathing or shortness of breath during the duration of the block. |
| Presence of Nausea or Vomiting | 24, 48, 72 hours | The investigators will ask the patient if there was any incidence of nausea or vomiting. |
| Presence of persistent paresthesia | 24, 48, and 72 hours. | The investigators will ask the patient if there is any presence of persistent paresthesia. |
Countries
United States
Contacts
CONTACTLeon N Grinman, DO
CONTACTBrett Elmore, MD
PRINCIPAL_INVESTIGATORLeon N Grinman, DO
UVA
Outcome results
None listed