A Study of the Pain Control Effectiveness of Interscalene Nerve Blocks versus Local Infiltration Analgesia Following Total Shoulder Joint Surgery

Overview

About this study

The purpose of this study is to compare the effectiveness of pain control between a single shot interscalene brachial plexus nerve block, a continuous interscalene brachial plexus nerve block, and a local infiltration analgesia. Total shoulder arthroplasty 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, there has been increasing interest in local infiltration analgesia use for total joint arthroplasty. The benefits of local infiltration analgesia within a comprehensive analgesia clinical pathway have yet to be established.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

American Society of Anesthesiologists (ASA) physiological status I-III
Presenting for unilateral primary total shoulder arthroplasty
including anatomic and reverse total shoulder arthroplasty
18 years of age and older
Able to provide informed consent for him or herself

Exclusion Criteria

Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
Chronic opioid use ( > 1 mos) with OME > 5 mg/day
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
  - 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
  - Uses home oxygen
  - Preoperative baseline oxygen saturation < 94% on room air
  - FEV 1 < 60% of predicted value (obstructive disease)
  - VC or TLC < 70% of predicted value (restrictive disease)
History of contralateral hemidiaphragmatic dysfunction (e.g., paralysis) or phrenic nerve injury
Contraindication to a regional anesthesia technique
- Preexisting neuropathy in the operative extremity
- Coagulopathy
- Sepsis
- Infection at site of injection
- Uncooperative
- Refusal
- Anticoagulation medications not held within appropriate time frame per 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
- If has a previous history of menopause, hysterectomy, or tubal ligation, will not be required to perform a pregnancy test
Impaired cognition

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Sandra Kopp, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Sandra Kopp, M.D.

Closed for enrollment

More information

Publications

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