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Local Infiltration Analgesia Vs. Interscalene Block in Total Shoulder Arthorplasty

NCT04415931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-03-14

No results posted yet for this study

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

Interventions

PROCEDURE

Local infiltration analgesia

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

PROCEDURE

Interscalene block

Standard interscalene brachial plexus regional block

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2022-03-01
Completion
2022-03-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415931 on ClinicalTrials.gov