Analgesic Efficacy of Interscalene Nerve Block Versus Local Infiltration Analgesia Following Total Shoulder Arthroplasty

Prospective, Randomized Controlled Trial Comparing Analgesic Efficacy of Single Injection vs. Continuous Interscalene Blockade vs. Local Infiltration Analgesia for Patients Undergoing Primary Total Shoulder Arthroplasty

Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in severe postoperative pain, especially in the first 48 hours after surgery. The use of interscalene brachial plexus nerve block remains the cornerstone for analgesia following shoulder surgery; however, with the advent of local infiltration analgesia (LIA), there has been increasing interest in its use for total joint arthroplasty.

Since the benefits of local infiltration analgesia within a comprehensive multi-modal analgesia clinical pathway have yet to be established for total shoulder arthroplasty, the Investigators plan to assess and compare analgesia outcomes between three intervention groups: single shot interscalene brachial plexus block (SISB), continuous interscalene brachial plexus block (CISB), and local infiltration analgesia (LIA).

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Single shot interscalene nerve block; Drug: Continuous interscalene nerve block; Drug: Local Infiltration Analgesia (LIA)

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
2. Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
3. Patients 18 years of age and older
4. Able to provide informed consent for him or herself

Exclusion Criteria:

1. Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
2. Chronic opioid use (>1 mos) with oral morphine equivalents (OME) >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
3. Body mass index (BMI) > 45 kg/m2
4. Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics.
5. History of Malignant Hyperthermia.

6. Major systemic medical problems such as:

   • Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
   • Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
   • Pre-existing medical history of moderate to severe pulmonary disease (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation < 94% on room air, forced expiratory volume in 1 second (FEV 1) < 60% of predicted value (obstructive disease), vital capacity (VC) or total lung capacity (TLC) < 70% predicted value (restrictive disease).37
   • History of contralateral hemidiaphragmatic dysfunction (e.g., paralysis) or phrenic nerve injury.
7. Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, refusal, anticoagulation medications not held within appropriate time frame per American Society of Regional Anesthesia (ASRA) guidelines.
8. Previous contralateral total shoulder replacement managed with regional anesthetic nerve block or periarticular injection/intraarticular injection within the previous 12 months.

9. Known to be currently pregnant or actively breastfeeding++

   • ++ Patients that have a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test.

10. Impaired cognition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Single shot interscalene nerve block; An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.	Drug: Single shot interscalene nerve block; Peripheral regional anesthesia nerve block - Single shot interscalene nerve block; Other Names: Interscalene brachial plexus block
ACTIVE_COMPARATOR: Continuous interscalene nerve block; An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the post-anesthesia care unit (PACU) with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.	Drug: Continuous interscalene nerve block; Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block; Other Names: Interscalene brachial plexus block
EXPERIMENTAL: Local Infiltration Analgesia (LIA); The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.	Drug: Local Infiltration Analgesia (LIA); Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery; Other Names: Arthroplasty Block; Peri-articular Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS).	The OBAS score was calculated using the sum of the scores from six questions. OBAS ranges from 0 (best) to 28 (worst), where a low score indicates a high benefit to the subjects.	Post-Operative Day 1

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (ESTIMATE): August 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pain, Postoperative/prevention & control; Brachial Plexus/ultrasonography; Nerve Block/methods; Anesthetics, Local/administration & dosage; Shoulder Pain/prevention & control
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 15-009646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO