Pain, Postoperative
Conditions
Keywords
Nerve Block/methods, Pain, Postoperative/prevention & control, Anesthetics, Local/administration & dosage, Brachial Plexus/ultrasonography, Shoulder Pain/prevention & control
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).
Interventions
DRUGSingle shot interscalene nerve block
Peripheral regional anesthesia nerve block - Single shot interscalene nerve block
DRUGContinuous interscalene nerve block
Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block
Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS). | Post-Operative Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block | 42 |
| 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 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.
Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block | 41 |
| 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.
Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery | 42 |
| Total | 125 |
Baseline characteristics
| Characteristic | Single Shot Interscalene Nerve Block | Continuous Interscalene Nerve Block | Local Infiltration Analgesia (LIA) | Total |
|---|---|---|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 13.1 | 68.1 years STANDARD_DEVIATION 10.1 | 69.5 years STANDARD_DEVIATION 8.9 | 68.4 years STANDARD_DEVIATION 10.7 |
| American Society of Anesthesiologists (ASA) Status ASA III | 14 Participants | 15 Participants | 15 Participants | 44 Participants |
| American Society of Anesthesiologists (ASA) Status ASA I/II | 28 Participants | 26 Participants | 27 Participants | 81 Participants |
| Body Mass Index | 30.3 kg/m^2 STANDARD_DEVIATION 5.2 | 30.2 kg/m^2 STANDARD_DEVIATION 5.7 | 30.9 kg/m^2 STANDARD_DEVIATION 5 | 30.4 kg/m^2 STANDARD_DEVIATION 5.3 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 42 participants | 41 participants | 42 participants | 125 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 17 Participants | 61 Participants |
| Sex: Female, Male Male | 20 Participants | 19 Participants | 25 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 41 | 0 / 42 |
| other Total, other adverse events | 1 / 42 | 3 / 41 | 1 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 41 | 1 / 42 |
Outcome results
Primary
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.
Time frame: Post-Operative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Shot Interscalene Nerve Block | Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS). | 2 score on a scale |
| Continuous Interscalene Nerve Block | Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS). | 0 score on a scale |
| Local Infiltration Analgesia (LIA) | Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS). | 3 score on a scale |
p-value: 0.542Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: 0.002Wilcoxon (Mann-Whitney)