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

NCT02876055 | Completed Phase 4 Results

• 1 other identifier: 15-009646
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pain, Postoperative

Keywords

Nerve Block/methods; Pain, Postoperative/prevention & control; Anesthetics, Local/administration & dosage; Brachial Plexus/ultrasonography; Shoulder Pain/prevention & control

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Single shot interscalene nerve block

ACTIVE COMPARATOR

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

Continuous interscalene nerve block

ACTIVE COMPARATOR

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

Local Infiltration Analgesia (LIA)

EXPERIMENTAL

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)

Interventions

Single shot interscalene nerve block DRUG

Peripheral regional anesthesia nerve block - Single shot interscalene nerve block

Also known as: Interscalene brachial plexus block

Single shot interscalene nerve block

Continuous interscalene nerve block DRUG

Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block

Also known as: Interscalene brachial plexus block

Continuous interscalene nerve block

Local Infiltration Analgesia (LIA) DRUG

Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery

Also known as: Arthroplasty Block, Peri-articular Injection

Local Infiltration Analgesia (LIA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
• Chronic opioid use (\>1 mos) with oral morphine equivalents (OME) \>5 mg/day OR acute opioid use (\< 1 mos) with OME \> 30 mg/day.
• Body mass index (BMI) \> 45 kg/m2
• Severe drug allergy\* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics.
• History of Malignant Hyperthermia.
• 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.
• 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.
• Previous contralateral total shoulder replacement managed with regional anesthetic nerve block or periarticular injection/intraarticular injection within the previous 12 months.
• 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.
• Impaired cognition

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Jason K. Panchamia
• Organization: Mayo Clinic

panchamia.jason@mayo.edu

507-284-9698

Study Officials

• Jason K Panchamia, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Anesthesiology

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)