Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
1 other identifier
interventional
100
1 country
6
Brief Summary
The purpose of this study is to examine the difference in perioperative pain after shoulder surgery with a standard bupivacaine nerve block compared to liposomal bupivacaine enhanced nerve block alone in TSA and ARCR. Data will be compared using VAS scores and opiate consumption between the two groups. The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedStudy Start
First participant enrolled
November 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 24, 2020
March 1, 2020
1.3 years
October 31, 2018
March 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Opiate Consumption
Total amount of narcotics consumed during the postoperative period, measured in morphine equivalents (OME)
Post-operative days 1-14
Secondary Outcomes (2)
VAS Pain Scores
Post operative days 1-14
Likert Pain Satisfaction Rating
Post operative days 1-14
Study Arms (2)
Liposomal Bupivacaine Interscalene Block
EXPERIMENTALLiposomal bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.
Bupivacaine Interscalene Block
NO INTERVENTIONBupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.
Interventions
Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron
Eligibility Criteria
You may qualify if:
- Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty
You may not qualify if:
- Pregnant
- Documented drug of alcohol abuse
- Active narcotic use prior to surgery
- Neurological deficit
- Allergy to amide anesthetics
- Not cleared by primary care physician
- Hydrocodone or oxycodone intolerance
- Enrollment in another clinical trial or past cognitive or mental health status that interferes with study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Greenwich Hospital
Greenwich, Connecticut, 06830, United States
Orthopaedic & Neurosurgery Specialists
Greenwich, Connecticut, 06831, United States
Stamford Ambulatory Surgical Center
Stamford, Connecticut, 06902, United States
Atlantis Orthopaedics
Atlantis, Florida, 06831, United States
Atlantis Orthopaedics
Palm Beach Gardens, Florida, 33410, United States
Southern Oregon Orthopedics, Inc.
Medford, Oregon, 97504, United States
Related Publications (6)
Kumar K, Gulotta LV, Dines JS, Allen AA, Cheng J, Fields KG, YaDeau JT, Wu CL. Unused Opioid Pills After Outpatient Shoulder Surgeries Given Current Perioperative Prescribing Habits. Am J Sports Med. 2017 Mar;45(3):636-641. doi: 10.1177/0363546517693665. Epub 2017 Feb 9.
PMID: 28182507BACKGROUNDLee CY, Robinson DA, Johnson CA Jr, Zhang Y, Wong J, Joshi DJ, Wu TT, Knight PA. A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. Ann Thorac Surg. 2019 Jan;107(1):128-134. doi: 10.1016/j.athoracsur.2018.06.081. Epub 2018 Aug 28.
PMID: 30170012BACKGROUNDPedoto A, Amar D. Liposomal Bupivacaine for Intercostal Nerve Block: Pricey or Priceless? Semin Thorac Cardiovasc Surg. 2017 Winter;29(4):538-539. doi: 10.1053/j.semtcvs.2017.08.016. Epub 2017 Aug 30. No abstract available.
PMID: 28967536BACKGROUNDRice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.
PMID: 25912739BACKGROUNDSurdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.
PMID: 25282071BACKGROUNDVandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.
PMID: 28157791BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 2, 2018
Study Start
November 21, 2018
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
March 24, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share