Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

Postoperative Pain Clinical Trial

Official title:

Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728946
• Other study ID #: 2018016
• Status: Completed
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Orthopaedic & Neurosurgery Specialists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Pain
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Drug:
• Liposomal Bupivacaine
Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron

Locations

Country	Name	City	State
United States	Atlantis Orthopaedics	Atlantis	Florida
United States	Greenwich Hospital	Greenwich	Connecticut
United States	Orthopaedic & Neurosurgery Specialists	Greenwich	Connecticut
United States	Southern Oregon Orthopedics, Inc.	Medford	Oregon
United States	Atlantis Orthopaedics	Palm Beach Gardens	Florida
United States	Stamford Ambulatory Surgical Center	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic & Neurosurgery Specialists

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate Consumption	Total amount of narcotics consumed during the postoperative period, measured in morphine equivalents (OME)	Post-operative days 1-14
Secondary	VAS Pain Scores	A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively	Post operative days 1-14
Secondary	Likert Pain Satisfaction Rating	A standardized measure of patient satisfaction with pain management from 1 (very unsatisfied) to 5 (very satisfied)	Post operative days 1-14