Opioid-Free Shoulder Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Post Op Pain
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing elective primary total shoulder or reverse total shoulder arthroplasty for osteoarthritis, avascular necrosis, cuff tear arthropathy, or inflammatory arthritis etiologies
- •Age greater than or equal to 50.
排除标准
- •Revision total shoulder arthroplasty
- •Chronic opioid therapy - per investigator discretion
- •Liver or renal insufficiency - per investigator discretion
- •Arthroplasty for fracture
- •Sickle cell disease
- •Workers compensation
- •Inability to receive block
- •Intervention Arm Only: Creatinine clearance less than 30 mL/min
- •Intervention Arm Only: Allergy to non-steroidal anti-inflammatory medications (NSAIDs).
研究组 & 干预措施
Non-Opioid Intervention
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.
干预措施: Gabapentin (Drug)
Non-Opioid Intervention
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.
干预措施: Celecoxib (Drug)
Non-Opioid Intervention
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.
干预措施: toradol (Drug)
Non-Opioid Intervention
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.
干预措施: acetaminophen (Drug)
Non-Opioid Intervention
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.
干预措施: regional block (Drug)
Non-Opioid Intervention
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.
干预措施: propofol (Drug)
Non-Opioid Intervention
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.
干预措施: IV lidocaine (Drug)
Non-Opioid Intervention
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.
干预措施: rocuronium (Drug)
Non-Opioid Intervention
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.
干预措施: vecuronium (Drug)
Non-Opioid Intervention
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.
干预措施: sevoflurane (Drug)
Non-Opioid Intervention
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.
干预措施: desflurane (Drug)
结局指标
主要结局
Post Op Pain
时间窗: 24 hours
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)
次要结局
- Additional Post Op Pain(6hrs, 12hrs, 2weeks, 2 months)
- Nausea(2 Months)
- Constipation(2 Months)
- Falls(2 Months)
- Morphine Use(In-hospital Stay)
- Pain Satisfaction(2 Months)
- ASES(2 Weeks)
- Simple Shoulder Test(2 Months)
- Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore(2 Months)