Mayo Clinic in Arizona
Phoenix, Arizona, 85054, United States
NCT Number: NCT03663283
The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Phoenix, Arizona, 85054, United States
This is a prospective, single-blinded randomized clinical trial comparing outcomes in patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine versus standard bupivacaine alone. Once consent is obtained, baseline characteristics will be recorded and patients will be randomized to intervention or control. Following surgery, patients will be followed until their 3-week post-operative visit. The primary outcome measure will be the mean difference in patient pain scores over the first 72 hours post-operatively between two groups. Secondary outcomes will include: (1) Total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks (2) Patient perceived duration of block determined as the time patient perceives complete resolution of block (3) Patient satisfaction with pain control at 72 hours, 3 weeks post-operatively and patient reported outcome measures (SANE, SST, ASES, VR-12) at 3 weeks post-operatively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Interscalene Nerve Blocks
Interscalene Nerve Blocks
Time frame: 72 hours post-operatively
Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.
Time frame: Measured at 72 hours and at 3 weeks post-operatively
Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks
Time frame: 4, 8, 12, 16, 20, 24, and 28 hours post-operatively
Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.
Time frame: Measured at 72 hours and at three weeks post-operatively
Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management.
Mayo Clinic
Other
Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty: A Single Blinded Prospective Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05499728
Arthritis, Arthritis Shoulder Glenohumoral Joint
Iowa City, Iowa, United States
View Trial DetailsNCT03727490
Arthropathy Shoulder
St Louis, Missouri, United States
View Trial DetailsNCT03735173
Arthralgia, Arthritis
Rochester, Minnesota, United States
View Trial DetailsNCT04449146
Arthropathy Shoulder, Shoulder Osteoarthritis
Brest, France
View Trial Details