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Purpose of Study:
To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
Background and Significance:
Opioid-based analgesia has been a cornerstone of patient care in the setting of acute pain for the last century and has undergone logarithmic increase over the past twenty years. Unfortunately, the rise in utilization has brought with it a rise in opioid-induced side effects. These include constipation, nausea/vomiting, hyperalgesia, delirium, addiction/withdrawal (with 67% of those prescribed a long-term opioid program still on opioids at an average of 4.8 years of follow-up), and in some cases even respiratory depression/death. Patient expectations of opioid-based pain medication has driven a rapid rise in outpatient opioid prescriptions including both short and long-acting opioids. These prescriptions have in turn become a source of significant mortality in the United States, with nearly 20,000 deaths due to opioid overdose in 2014 alone.
There have been momentous efforts made in identifying synergistic compounds to use for acute pain management in the perioperative time period to begin to minimize the opioid requirement for pain control. These studies have focused on nerve modulation with gabapentinoids, intravenous and local administration of sodium-channel blockers such as lidocaine and bupivacaine, and even increased interest in non-steroidal anti-inflammatories and acetaminophen. At this time, no study has looked at the possibility of utilizing a multi-modal acute post-surgical pain control pathway that did not include some form of opioid medication for the general population.
Arthroplasty continues to be a dominant procedure in the orthopaedic armamentarium and accounts for well over a million surgeries done in the United States per year. With the ability to utilize targeted nerve blocks by anesthesia, and the increasing data showing efficacy of multi-modal therapy for acute pain, we propose a patient care pathway that is completely free of all opioid-based medications. From the time that patients are checked in until the time the patient follows up in clinic, they will utilize a pathway designed to eliminate pain and opioid-related side effects following shoulder arthroplasty. Our hope is that a well-designed pathway for total shoulder arthroplasty can quickly be modeled for other surgical procedures in an attempt to minimize the negative effects of opioid utilization both acutely and on a societal level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | No Intervention | The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon. | |
| Non-Opioid Intervention | Active Comparator | Oral dose of both gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without the aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but should include one dose of IV acetaminophen during the procedure. Anesthetic modalities will include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). As needed medications will include both oral and IV acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Op Pain | Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Post Op Pain | post-operative pain: measured on a 0 (no pain) -10 (worst) numeric rating scale (NRS) at 6hrs, 12hrs, 2 weeks, and 2 months. A score of 0(no pain) is preferable to 10(worst possible pain) | 6hrs, 12hrs, 2weeks, 2 months |
| Nausea |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24829420 | Background | Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137. | |
| 25473457 | Background | Lee HJ, Yeomans DC. Opioid induced hyperalgesia in anesthetic settings. Korean J Anesthesiol. 2014 Nov;67(5):299-304. doi: 10.4097/kjae.2014.67.5.299. Epub 2014 Nov 26. |
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Patients were identified in clinic by the surgeon performing the shoulder arthroplasty. The surgeon introduced the concept of opioid-free arthroplasty with the patients, who then chose whether to follow the traditional or opioid-free pathway. The surgeon then notified the study coordinator of the patient's decision and patients were consented.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational | The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon. |
| FG001 | Non-Opioid Intervention | Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational | The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post Op Pain | Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain) | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours |
|
Adverse event data was collected from the time of study treatment (surgery) through the end of subject participation (1 year postoperative visit).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational | The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for ileus | Gastrointestinal disorders | patient reported | Non-systematic Assessment | Patient was hospitalized for >24 hours for an ileus. Determined to be not related to the study. |
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Enrollment into either pathway was voluntary, not randomized. Patient-kept diaries are difficult data to rely on. Only examines the short-term recovery of the patients undergoing TSA/RTSA. Did not evaluate the cost with each treatment arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Odum | OrthoCarolina Research Institute | 7049457710 | susan.odum@orthocarolina.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2017 | Aug 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D000070636 | Rotator Cuff Injuries |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000068579 | Celecoxib |
| D020911 | Ketorolac Tromethamine |
| D000082 | Acetaminophen |
| D015742 | Propofol |
| D008012 | Lidocaine |
| D000077123 | Rocuronium |
| D014673 | Vecuronium Bromide |
| D000077149 | Sevoflurane |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Celecoxib | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| toradol | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| acetaminophen | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| regional block | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| propofol | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| IV lidocaine | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| rocuronium | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| vecuronium | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| sevoflurane | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
| desflurane | Drug | opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment |
|
rate of nausea |
| 2 Weeks |
| Constipation | rate of constipation | 2 Weeks |
| Falls | rate of falls | 2 Weeks |
| Morphine Use | Morphine milli-equivalents In-hospital post-operative. Continuous scale of MME, no defined better/worse. Measured as number and dose of medications taken. For example, if the patient received an opioid, the drug and dose was recorded and converted to MME. A time frame of when to assess opioid use in-hospital post-operative was not used but was a continuous monitor for rescue opioid from in-hospital post-operative through discharge. | In-hospital Stay |
| Pain Satisfaction | Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes. | 2 Weeks |
| ASES | American Shoulder and Elbow Surgeons (ASES) Shoulder Score for pain and function. Range 0-100. Low score = worse shoulder condition. Function, disability, and pain subscores (all ranges 0-50), and are summed for total ASES score. | 2 Weeks |
| Simple Shoulder Test | Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score. | 2 Weeks |
| Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore | quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health. | 2 Weeks |
| Nausea | rate of nausea | 2 Months |
| Constipation | rate of constipation | 2 Months |
| Falls | rate of falls | 2 Months |
| Pain Satisfaction | Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes. | 2 Months |
| Simple Shoulder Test | Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score. | 2 Months |
| Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore | quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health. | 2 Months |
| 26315638 | Background | McKeown JL. Pain Management Issues for the Geriatric Surgical Patient. Anesthesiol Clin. 2015 Sep;33(3):563-76. doi: 10.1016/j.anclin.2015.05.010. Epub 2015 Jul 3. |
| 25233168 | Background | Macintyre PE, Huxtable CA, Flint SL, Dobbin MD. Costs and consequences: a review of discharge opioid prescribing for ongoing management of acute pain. Anaesth Intensive Care. 2014 Sep;42(5):558-74. doi: 10.1177/0310057X1404200504. |
| 16636030 | Background | Seib RK, Paul JE. Preoperative gabapentin for postoperative analgesia: a meta-analysis. Can J Anaesth. 2006 May;53(5):461-9. doi: 10.1007/BF03022618. |
| 26300519 | Background | Doleman B, Heinink TP, Read DJ, Faleiro RJ, Lund JN, Williams JP. A systematic review and meta-regression analysis of prophylactic gabapentin for postoperative pain. Anaesthesia. 2015 Oct;70(10):1186-204. doi: 10.1111/anae.13179. Epub 2015 Aug 24. |
| 25209095 | Background | Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10. |
| 24972430 | Background | Banerjee P, Rogers BA. Systematic review of high-volume multimodal wound infiltration in total knee arthroplasty. Orthopedics. 2014 Jun;37(6):403-12. doi: 10.3928/01477447-20140528-07. |
| 24996539 | Background | Marques EM, Jones HE, Elvers KT, Pyke M, Blom AW, Beswick AD. Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness. BMC Musculoskelet Disord. 2014 Jul 5;15:220. doi: 10.1186/1471-2474-15-220. |
| 24992382 | Background | Skolnik A, Gan TJ. New formulations of bupivacaine for the treatment of postoperative pain: liposomal bupivacaine and SABER-Bupivacaine. Expert Opin Pharmacother. 2014 Aug;15(11):1535-42. doi: 10.1517/14656566.2014.930436. Epub 2014 Jul 3. |
| 25380221 | Background | Kazerooni R, Tran MH. Evaluation of Celecoxib Addition to Pain Protocol After Total Hip and Knee Arthroplasty Stratified by Opioid Tolerance. Clin J Pain. 2015 Oct;31(10):903-8. doi: 10.1097/AJP.0000000000000178. |
| 26760402 | Background | Khan JS, Margarido C, Devereaux PJ, Clarke H, McLellan A, Choi S. Preoperative celecoxib in noncardiac surgery: A systematic review and meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2016 Mar;33(3):204-14. doi: 10.1097/EJA.0000000000000346. |
| 25664148 | Background | Koh W, Nguyen KP, Jahr JS. Intravenous non-opioid analgesia for peri- and postoperative pain management: a scientific review of intravenous acetaminophen and ibuprofen. Korean J Anesthesiol. 2015 Feb;68(1):3-12. doi: 10.4097/kjae.2015.68.1.3. Epub 2015 Jan 28. |
| 26991963 | Background | Nir RR, Nahman-Averbuch H, Moont R, Sprecher E, Yarnitsky D. Preoperative preemptive drug administration for acute postoperative pain: A systematic review and meta-analysis. Eur J Pain. 2016 Aug;20(7):1025-43. doi: 10.1002/ejp.842. Epub 2016 Mar 15. |
| 25436192 | Background | Rouhani A, Tabrizi A, Elmi A, Abedini N, Mirza Tolouei F. Effects of preoperative non-steroidal anti-inflammatory drugs on pain mitigation and patients' shoulder performance following rotator cuff repair. Adv Pharm Bull. 2014 Dec;4(4):363-7. doi: 10.5681/apb.2014.053. Epub 2014 Aug 10. |
| 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. |
| 24825360 | Background | Chan EY, Fransen M, Parker DA, Assam PN, Chua N. Femoral nerve blocks for acute postoperative pain after knee replacement surgery. Cochrane Database Syst Rev. 2014 May 13;2014(5):CD009941. doi: 10.1002/14651858.CD009941.pub2. |
| 24492959 | Background | Ullah H, Samad K, Khan FA. Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery. Cochrane Database Syst Rev. 2014 Feb 4;2014(2):CD007080. doi: 10.1002/14651858.CD007080.pub2. |
| 26209853 | Background | Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth. 2015 Dec;115(6):861-6. doi: 10.1093/bja/aev257. Epub 2015 Jul 25. |
| 25124340 | Background | Dahl JB, Nielsen RV, Wetterslev J, Nikolajsen L, Hamunen K, Kontinen VK, Hansen MS, Kjer JJ, Mathiesen O; Scandinavian Postoperative Pain Alliance (ScaPAlli). Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. Acta Anaesthesiol Scand. 2014 Nov;58(10):1165-81. doi: 10.1111/aas.12382. Epub 2014 Aug 14. |
| 27036605 | Background | Dunn LK, Durieux ME, Nemergut EC. Non-opioid analgesics: Novel approaches to perioperative analgesia for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):79-89. doi: 10.1016/j.bpa.2015.11.002. Epub 2015 Nov 24. |
| 26186325 | Background | Halawi MJ, Grant SA, Bolognesi MP. Multimodal Analgesia for Total Joint Arthroplasty. Orthopedics. 2015 Jul 1;38(7):e616-25. doi: 10.3928/01477447-20150701-61. |
| 25599296 | Background | Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003. |
| 24399578 | Background | McCartney CJ, Nelligan K. Postoperative pain management after total knee arthroplasty in elderly patients: treatment options. Drugs Aging. 2014 Feb;31(2):83-91. doi: 10.1007/s40266-013-0148-y. |
| 2240918 | Background | Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941. |
| 26814246 | Background | YaDeau JT, Gordon MA, Goytizolo EA, Lin Y, Fields KG, Goon AK, Holck G, Miu TW, Gulotta LV, Dines DM, Craig EV. Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. Pain Med. 2016 May;17(5):940-60. doi: 10.1093/pm/pnv010. Epub 2015 Dec 14. |
| 21411827 | Background | Michener LA, Snyder AR, Leggin BG. Responsiveness of the numeric pain rating scale in patients with shoulder pain and the effect of surgical status. J Sport Rehabil. 2011 Feb;20(1):115-28. doi: 10.1123/jsr.20.1.115. |
| never had surgery after signing consent |
|
| BG001 |
| Non-Opioid Intervention |
Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
|
|
|
| Secondary | Additional Post Op Pain | post-operative pain: measured on a 0 (no pain) -10 (worst) numeric rating scale (NRS) at 6hrs, 12hrs, 2 weeks, and 2 months. A score of 0(no pain) is preferable to 10(worst possible pain) | Posted | Median | Inter-Quartile Range | score on a scale | 6hrs, 12hrs, 2weeks, 2 months |
|
|
|
|
| Secondary | Nausea | rate of nausea | Posted | Count of Participants | Participants | 2 Weeks |
|
|
|
|
| Secondary | Constipation | rate of constipation | Posted | Count of Participants | Participants | 2 Weeks |
|
|
|
|
| Secondary | Falls | rate of falls | Posted | Count of Participants | Participants | 2 Weeks |
|
|
|
|
| Secondary | Morphine Use | Morphine milli-equivalents In-hospital post-operative. Continuous scale of MME, no defined better/worse. Measured as number and dose of medications taken. For example, if the patient received an opioid, the drug and dose was recorded and converted to MME. A time frame of when to assess opioid use in-hospital post-operative was not used but was a continuous monitor for rescue opioid from in-hospital post-operative through discharge. | Posted | Median | Inter-Quartile Range | Morphine milli-equivalents | In-hospital Stay |
|
|
|
| Secondary | Pain Satisfaction | Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes. | Posted | Count of Participants | Participants | 2 Weeks |
|
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|
| Secondary | ASES | American Shoulder and Elbow Surgeons (ASES) Shoulder Score for pain and function. Range 0-100. Low score = worse shoulder condition. Function, disability, and pain subscores (all ranges 0-50), and are summed for total ASES score. | Posted | Median | Inter-Quartile Range | units on a scale | 2 Weeks |
|
|
|
|
| Secondary | Simple Shoulder Test | Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score. | Posted | Median | Inter-Quartile Range | score on a scale | 2 Weeks |
|
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|
|
| Secondary | Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore | quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health. | Posted | Median | Inter-Quartile Range | score on a scale | 2 Weeks |
|
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|
| Secondary | Nausea | rate of nausea | Posted | Count of Participants | Participants | 2 Months |
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|
| Secondary | Constipation | rate of constipation | Posted | Count of Participants | Participants | 2 Months |
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| Secondary | Falls | rate of falls | Posted | Count of Participants | Participants | 2 Months |
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| Secondary | Pain Satisfaction | Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes. | Posted | Count of Participants | Participants | 2 Months |
|
|
|
|
| Secondary | Simple Shoulder Test | Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score. | Posted | Median | Inter-Quartile Range | score on a scale | 2 Months |
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|
|
| Secondary | Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore | quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health. | Posted | Median | Inter-Quartile Range | score on a scale | 2 Months |
|
|
|
|
| 0 |
| 48 |
| 1 |
| 48 |
| 0 |
| 48 |
| EG001 | Non-Opioid Intervention | Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance. | 0 | 38 | 2 | 38 | 0 | 38 |
|
| DVT and pulmonary embolism | Blood and lymphatic system disorders | patient reported | Non-systematic Assessment | Patient was hospitalized for >24 hours for a deep vein thrombosis and pulmonary embolism. Determined to be unlikely related to the study. |
|
| mesenteric artery stenosis | Gastrointestinal disorders | patient reported | Non-systematic Assessment | Patient was hospitalized >24 hours for lower quadrant abdominal pain diagnosed as mesenteric artery stenosis. Determined to be unlikely related to study. |
|
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D007592 | Joint Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D010636 | Phenols |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D005019 | Ethyl Ethers |
| 2 weeks |
|
| 2 months |
|
| 0.005 |
| Other |
| Unknown |
|
| Unknown |
|
| Unknown |
|
| Unknown |
|
| 0.3911 |
| Other |
| Unknown |
|
| Unknown |
|
| Unknown |
|
| Unknown |
|
| 0.2486 |
| Other |