Clinical trial NCT03728946: Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
Official title: Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Postoperative Pain
Lead sponsor: Orthopaedic & Neurosurgery Specialists
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Arthroscopic rotator cuff repair (ARCR) and shoulder arthroplasty (TSA) provide excellent clinical outcomes but are often associated with significant postoperative pain, frequently managed with oral opioid medication. Orthopedic surgeons prescribe approximately 32 unused pills per shoulder surgery and are the third largest prescribers of opiates in the USA. It is incumbent upon the orthopedic community to identify postoperative pain management methods which reduce the need for narcotic medication following shoulder procedures as a means to mitigate the impact of orthopedic procedures on this epidemic.

The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is an accepted approach for managing surgical pain and reducing opiate use but requires peer reviewed protocols to gain wider acceptance.

Interscalene nerve block with bupivacaine remains a gold standard for peri-operative analgesia, but is associated with significant rebound pain due to the short duration of the local anesthetics. Recent studies have demonstrated that the addition of a liposomal bupivacaine field block may lower pain and enhance patient satisfaction throughout the first postoperative week. Liposomal bupivacaine has recently received FDA approval for ISB, but the data regarding its efficacy in nerve blocks is sparse.

The purpose of this pilot study is to determine if liposomal bupivacaine-enhanced interscalene nerve blocks can be used to improve peri-operative pain control methods, limit narcotic use, and provide appropriate postoperative analgesia compared to standard bupivacaine blocks. Primary and secondary outcome measures will be collected as number of opiates taken and self-reported VAS pain scores over a 14 day postoperative period, respectively.

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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty

Exclusion Criteria:

* 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

Primary outcomes:
measure: Opiate Consumption
timeFrame: Post-operative days 1-14
Secondary outcomes:
measure: VAS Pain Scores
timeFrame: Post operative days 1-14
measure: Likert Pain Satisfaction Rating
timeFrame: Post operative days 1-14
Other outcomes:
Locations:
city: Greenwich
country: United States
facility: Greenwich Hospital
state: Connecticut
city: Greenwich
country: United States
facility: Orthopaedic & Neurosurgery Specialists
state: Connecticut
city: Stamford
country: United States
facility: Stamford Ambulatory Surgical Center
state: Connecticut
city: Atlantis
country: United States
facility: Atlantis Orthopaedics
state: Florida
city: Palm Beach Gardens
country: United States
facility: Atlantis Orthopaedics
state: Florida
city: Medford
country: United States
facility: Southern Oregon Orthopedics, Inc.
state: Oregon
Study officials:
References:
citation: 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.
citation: Lee 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.
citation: Pedoto 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.
citation: Rice 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.
citation: Surdam 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.
citation: Vandepitte 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.