Clinical Trials Logo

Clinical Trial Summary

Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia or as a sole primary technique comes to one's rescue. Interscalene block either as single shot or as a catheter is an established modality for effective analgesia which facilitates early mobilization helping in physical therapy and early discharge. With the help of local anesthetic injected as a single shot, analgesia usually lasts less than 24 hours. Recent research in regional anesthesia is advancing towards adjuvants which will prolong the duration of local anesthesia. This has introduced the concept of "multimodal perineural analgesia (MMPNA)" whereby multiple agents with differing mechanisms of action are used with the goal of providing perineural analgesia while avoiding exposure to high and potentially toxic levels of individual agents. Some of the commonly used adjuvants in clinical studies are fentanyl, buprenorphine, morphine, tramadol, magnesium, epinephrine, ketamine, non-steroidal anti-inflammatory drug (NSAID), midazolam, parecoxib, ketorolac, clonidine, dexmedetomidine, dexamethasone, neostigmine and potassium. They find a distinct place in wide spread clinical practice as an off-label use. Steroids have a long history of safe use in epidural space for treatment of radicular pain due to nerve irritation. Dexamethasone is used routinely as a part of anti- emetic prophylaxis and anti-inflammatory effect. Methyl prednisone was the first steroid to be used as an adjuvant. Dexamethasone was first used as an adjuvant in 2003. It has been hypothesized that steroids induce a degree of vasoconstriction, thereby reducing local anesthetic absorption, tend to have an opioid sparing effect. Another theory suggests that it increases the activity of inhibitory potassium channels on nociceptive C-fibers (via glucocorticoid receptors), thus decreasing their activity. Several studies have demonstrated promising results with the use of 8mg of perineural dexamethasone. No neuronal injury has been reported in in vivo studies. Though there are several studies which report usage of dexamethasone in varying doses of 2mg to 8mg, the optimal effective dose of dexamethasone as an adjuvant for nerve block remains unknown. Some studies have suggested perineural is more effective than IV as an adjuvant . Liposomal bupivacaine, a formulation where bupivacaine is encapsulated into multivesicular liposomes, making it a slow and controlled release from the liposomes, was originally indicated for wound infiltration at the surgical site to provide post-surgical analgesia. Studies have demonstrated efficacy up to 24 hours in femoral nerve block in total knee arthroplasty. Recent approval of liposomal bupivacaine in interscalene block for shoulder surgeries by FDA opens an arena unexplored in the world of regional anesthesia. Current opioid epidemic, a crisis in health care forces healthcare providers to consider alternate analgesic modalities without compromising patient comfort. Regional anesthesia has revolutionized peri-operative pain management by avoiding opioids and their side effects. Use of adjuvants to the current regional techniques holds promise in postsurgical analgesia. The researchers propose to compare the analgesic efficacy of liposomal bupivacaine to bupivacaine with dexamethasone as an adjuvant in interscalene block with catheters for shoulder surgeries. Till date, there is not a single study comparing the three in current literature.


Clinical Trial Description

There have been several studies demonstrating efficacy of dexamethasone in prolonging the analgesic effect when administered both perineurally and intra-venously as an adjuvant to local anesthesia demonstrating a dose effect relationship. Liposomal bupivacaine has shown promising results in total knee arthroplasty and there are a limited number of studies demonstrating efficacy in total shoulder arthroplasty. If by comparing dexamethasone as an adjuvant to bupivacaine and liposomal formulation is deciphered, it can help in avoiding costs associated with liposomal bupivacaine extending post-operative analgesia avoiding narcotics and reducing health care costs. And comparing the two to the standard catheters helps us understand if they have a role in pain management in the future. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03969875
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase
Start date August 18, 2018
Completion date April 5, 2022

See also
  Status Clinical Trial Phase
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Recruiting NCT06025331 - Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA? N/A
Recruiting NCT06153381 - Virtual Rehabilitation Assistant Via Instant Messaging Communication to Promote Adherence to Rehabilitation After Reverse Shoulder Replacement N/A
Recruiting NCT04762667 - Individual Preoperative Planning for RSA N/A
Recruiting NCT06025448 - Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability? N/A
Completed NCT03854357 - Subscapularis Strength After Total Shoulder Arthroplasty N/A
Recruiting NCT05408065 - Comparison of the Analgesic Effect of 2 Shoulder Infiltrations N/A
Recruiting NCT05048264 - Effect of Corticosteroid Injections on Blood Glucose
Recruiting NCT05395819 - Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis N/A
Recruiting NCT06381791 - CBD for Pain Following Orthopedic Shoulder Surgery Phase 1/Phase 2
Active, not recruiting NCT04405297 - A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells
Not yet recruiting NCT05868330 - Comparison of Interscalene Catheter to Single Injection Interscalene Blocks for Total Shoulder Arthroplasties N/A
Recruiting NCT05675527 - PRP for Glenohumeral Osteoarthritis Phase 4
Recruiting NCT06319911 - AETOS Shoulder System
Withdrawn NCT03474510 - Effective Pain Management During Shoulder Replacement Surgery With EXPAREL Phase 4
Completed NCT05043493 - Effect of PRP as Therapy for Shoulder Osteoarthritis N/A
Recruiting NCT05788614 - Retroversion in Reverse Shoulder Arthroplasty N/A
Not yet recruiting NCT06435494 - Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions N/A
Withdrawn NCT04285606 - Effect of Postop Rehab Methods on Outcomes Following Reverse Shoulder Arthroplasty N/A
Recruiting NCT04984291 - Zimmer Biomet Shoulder Arthroplasty PMCF N/A