Local Infiltration Analgesia Vs. Interscalene Block in Total Shoulder Arthorplasty

NCT04415931 | Completed

• 1 other identifier: 2022248
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Pain management following total shoulder arthroplasty is an important factor in determining patient outcomes and satisfaction. Interscalene brachial plexus blockade has been used successfully to minimize pain in the acute post-operative period. While shown to be effective, interscalene blockade has known complications. In addition, interscalene block has been shown to be significantly more expensive when compared to local anesthesia infiltration. Local anesthetics such as bupivacaine have long been used to assist in post-operative anesthesia. Recent reports have demonstrated local infiltration of liposomal bupivacaine to be similar to interscalene block in regards to patient analgesia even in the first 24 hours post operatively, with the added benefit of lower complications and costs. While most reports examine the efficacy of local infiltration with liposomal bupivacaine in the shoulder, other total joint literature has been positive regarding the use of local infiltration analgesic mixture for improved post-operative analgesia using a multi-modal approach to infiltrative analgesia. Despite these reports, the role and efficacy of local infiltration analgesia in shoulder arthroplasty is lacking. The purpose of the proposed study is to determine the efficacy and safety of local infiltration analgesia in shoulder arthroplasty in comparison to interscalene block through a randomized prospective clinical trial. Our hypothesis is that local infiltration analgesia will lead to postoperative pain scores, opiate consumption, and complication rate that are not significantly different from interscalene block.

Conditions

Shoulder Osteoarthritis; Cuff Tear Arthropathy; Massive Rotator Cuff Tear

Keywords

Total Shoulder arthroplasty; Reverse Shoulder arthroplasty; Cuff tear arthropathy; massive irreparable rotator cuff tear; Anatomic total shoulder arthroplasty; Shoulder osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Pain visual analog scale (VAS)

  Following surgery, the patient's pain level will be recorded in a visual analog scale (VAS) at 4 hours, 8 hours, 12 hours, 24 hours, 2 days and daily until 7 days, and then at 14 days.

  From 4 hours to 14 days postop

• Opiate consumption

  The patient's daily opiate consumption during the first 7 days following surgery and the toal accumulated amount of opiate consumption by 2 weeks postop will also be recorded, quantified and converted to morphine equivalents units (MEU) for standardization

  From postop day 1 to 2 weeks

Secondary Outcomes (4)

• Length of hospital stay

  for postoperative 1 week

• Postoperative complications

  for postoperative 3 months

• Intraoperative complications

  Intraoperative

• Length of surgical procedure

  Intraoperative

Study Arms (2)

Local infiltration analgesia group

EXPERIMENTAL

This group of patients will receive local infiltration analgesia

Procedure: Local infiltration analgesia

Interscalene block group

ACTIVE COMPARATOR

This group of patients will receive interscalene block

Procedure: Interscalene block

Interventions

Local infiltration analgesia PROCEDURE

Local infiltration injection intraoperatively prior to closing during the procedure. A standardized dose of 100 mL of infiltration will be utilized according to the following formula. The mixture will be injected into the deltoid and pectoralis major muscles and fasciae, and subcutaneous tissues using an 18-guage needle. Total dose 100mL Ropivacaine 0.5% 40mL Epinephrine 1mg/mL 0.1mL Ketorolac 30mg/mL 1mL Morphine 10mg/mL 0.5mL Normal saline 0.9% 58.4mL

Local infiltration analgesia group

Interscalene block PROCEDURE

Standard interscalene brachial plexus regional block

Interscalene block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years of age or greater)
• Primary anatomic or reverse total shoulder arthroplasty secondary to osteoarthritis, cuff tear arthropathy, or massive irreparable rotator cuff tear

You may not qualify if:

• Narcotic dependent
• Previous ipsilateral open shoulder surgery
• Chronic pain syndromes (fibromyalgia)
• Contraindication to regional anesthesia
• Cervical radiculopathy
• Workers compensation insurance
• Mentally Disabled.
• Pregnant Patients

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (11)

• Menendez ME, Lawler SM, Ring D, Jawa A. High pain intensity after total shoulder arthroplasty. J Shoulder Elbow Surg. 2018 Dec;27(12):2113-2119. doi: 10.1016/j.jse.2018.08.001. Epub 2018 Oct 12.

  PMID: 30322752 RESULT

• Bjornholdt KT, Jensen JM, Bendtsen TF, Soballe K, Nikolajsen L. Local infiltration analgesia versus continuous interscalene brachial plexus block for shoulder replacement pain: a randomized clinical trial. Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1245-52. doi: 10.1007/s00590-015-1678-2. Epub 2015 Aug 15.

  PMID: 26276164 RESULT

• Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Interscalene Block with and without Intraoperative Local Infiltration with Liposomal Bupivacaine in Shoulder Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 15;100(16):1373-1378. doi: 10.2106/JBJS.17.01416.

  PMID: 30106818 RESULT

• Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Randomized Controlled Trial of Interscalene Block Compared with Injectable Liposomal Bupivacaine in Shoulder Arthroplasty. J Bone Joint Surg Am. 2017 Apr 5;99(7):550-556. doi: 10.2106/JBJS.16.00296.

  PMID: 28375887 RESULT

• Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, Kolowich PA, Muh SJ. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg. 2016 Nov;25(11):1742-1748. doi: 10.1016/j.jse.2016.05.007. Epub 2016 Jul 14.

  PMID: 27422692 RESULT

• Sabesan VJ, Shahriar R, Petersen-Fitts GR, Whaley JD, Bou-Akl T, Sweet M, Milia M. A prospective randomized controlled trial to identify the optimal postoperative pain management in shoulder arthroplasty: liposomal bupivacaine versus continuous interscalene catheter. J Shoulder Elbow Surg. 2017 Oct;26(10):1810-1817. doi: 10.1016/j.jse.2017.06.044. Epub 2017 Aug 24.

  PMID: 28844420 RESULT

• Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.

  PMID: 25822923 RESULT

• Sicard J, Klouche S, Conso C, Billot N, Auregan JC, Poulain S, Lespagnol F, Solignac N, Bauer T, Ferrand M, Hardy P. Local infiltration analgesia versus interscalene nerve block for postoperative pain control after shoulder arthroplasty: a prospective, randomized, comparative noninferiority study involving 99 patients. J Shoulder Elbow Surg. 2019 Feb;28(2):212-219. doi: 10.1016/j.jse.2018.09.026. Epub 2018 Dec 10.

  PMID: 30545786 RESULT

• Weller WJ, Azzam MG, Smith RA, Azar FM, Throckmorton TW. Liposomal Bupivacaine Mixture Has Similar Pain Relief and Significantly Fewer Complications at Less Cost Compared to Indwelling Interscalene Catheter in Total Shoulder Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3557-3562. doi: 10.1016/j.arth.2017.03.017. Epub 2017 Mar 16.

  PMID: 28390888 RESULT

• Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.

  PMID: 24939863 RESULT

• Tashjian RZ, Hung M, Keener JD, Bowen RC, McAllister J, Chen W, Ebersole G, Granger EK, Chamberlain AM. Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Jan;26(1):144-148. doi: 10.1016/j.jse.2016.06.007. Epub 2016 Aug 18.

  PMID: 27545048 RESULT

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized prior to their scheduled surgery date by our research team using a randomization protocol developed by our department biostatistics team. The surgeons and anesthesiologists will be blinded about the group assignment until the day before surgery. The group assignment will be sealed in an envelope and delivered to the surgeon.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR OF CLINICAL ORTHOPAEDIC SURGERY

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: August 15, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 13, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be shared from actual study date until actual completion date
• Access Criteria: * Treating relationship with a research team member listed on the IRB application. * Research team members will work directly with providers that have a treating (patient-provider) relationship

Locations

US (1)