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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concentrated | Active Comparator | Standard management of higher percent local anesthetic: 0.5% Bupivacaine |
|
| Dilute | Experimental | More dilute local : 0.25% Bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Max NRS Pain Score at 24 hours | Patients will be Assessed 24 hours after intervention for a pain score between 0 and 10, 10 being the worst pain imaginable. | 24 hours after intervention; will also be assessed at 48 and 72 hours, though these are not the primary outcome for the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Qor15 score questionnaire. | Patient will answer QoR15 questionnaire | 24, 48 and 72 hours. |
| Lowest NRS pain score | Patient will be assessed for lowest NRS pain scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leon N Grinman, DO | Contact | 434-924-3627 | Lngrinman@gmail.com | |
| Brett Elmore, MD | Contact | 434-924-3627 | elmorbr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Leon N Grinman, DO | UVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA Health | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9773699 | Background | Al-Kaisy A, McGuire G, Chan VW, Bruin G, Peng P, Miniaci A, Perlas A. Analgesic effect of interscalene block using low-dose bupivacaine for outpatient arthroscopic shoulder surgery. Reg Anesth Pain Med. 1998 Sep-Oct;23(5):469-73. | |
| 22664978 | Background | Fredrickson MJ, Abeysekera A, White R. Randomized study of the effect of local anesthetic volume and concentration on the duration of peripheral nerve blockade. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):495-501. doi: 10.1097/AAP.0b013e3182580fd0. |
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The details of the IPD Plan are unknown at this time, but it will likely be shared.
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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randomized control study
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| 24, 48, 72 hours |
| Opioid Use | Total doses used will be converted to MMEs. | Assessed at 72 hours |
| Sensory Block Duration | We will ask the patient how long they felt the nerve block was effective, in terms of hours. | Assessed at 24 hours. |
| Presence of dyspnea/shortness of breath | We will ask the patient if they ever had trouble breathing or shortness of breath during the duration of the block. | Assessed at 24 hours. |
| Presence of Nausea or Vomiting | We will ask the patient if there was any incidence of nausea or vomiting. | 24, 48, 72 hours |
| Presence of persistent paresthesia | We will ask the patient if there is any presence of persistent paresthesia. | 24, 48, and 72 hours. |
| 37337808 | Background | Lee HJ, Woo JH, Chae JS, Kim YJ, Shin SJ. Intravenous Versus Perineural Dexamethasone for Reducing Rebound Pain After Interscalene Brachial Plexus Block: A Randomized Controlled Trial. J Korean Med Sci. 2023 Jun 19;38(24):e183. doi: 10.3346/jkms.2023.38.e183. |
| 34535548 | Background | Woo JH, Lee HJ, Oh HW, Lee JW, Baik HJ, Kim YJ. Perineural dexamethasone reduces rebound pain after ropivacaine single injection interscalene block for arthroscopic shoulder surgery: a randomized controlled trial. Reg Anesth Pain Med. 2021 Nov;46(11):965-970. doi: 10.1136/rapm-2021-102795. Epub 2021 Sep 17. |
| 37833472 | Background | Uppal V, Barry G, Ke JXC, Kwofie MK, Trenholm A, Khan M, Shephard A, Retter S, Shanthanna H. Reducing rebound pain severity after arthroscopic shoulder surgery under general anesthesia and interscalene block: a two-centre randomized controlled trial of pre-emptive opioid treatment compared with placebo. Can J Anaesth. 2024 Jun;71(6):773-783. doi: 10.1007/s12630-023-02594-0. Epub 2023 Oct 13. |
| 33390261 | Background | Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31. |
| 25822923 | Background | Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688. |
| 30124544 | Background | Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651. |
| D000588 |
| Amines |