Analgesic Efficacy of Interscalene Nerve Block Versus Local Infiltration Analgesia Following Total Shoulder Arthroplasty
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 2016 |
| End Date: | February 2018 |
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).
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).
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 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, FEV 1 < 60% of predicted value (obstructive disease), VC or
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 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
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Jason Panchamia, DO
Phone: 507-255-6804
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