Brachial Plexus Block, Pain, Postoperative
Conditions
Keywords
Interscalene nerve block, total shoulder arthroplasty, pain management, OBAS, QoR-15
Brief summary
This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.
Interventions
DRUGBupivacaine HCl
Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
DRUGLiposomal bupivacaine + Bupivacaine Hcl 0.5% Inj
Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Unblinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Chronic pain syndromes * Chronic opioid use (\>1 month) with OME \>5 mg/day OR acute opioid use (\< 1 month) 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 local anesthetics. \*defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever * Personal or family 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 requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation \< 93% on room air. * History of contralateral hemidiaphragm 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, and refusal). o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia. * Known to be currently pregnant or actively breastfeeding++ o ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf) * Impaired cognition (e.g. Alzheimer's disease, moderate to severe dementia, encephalopathy) * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Score at Rest at 24 Hours Post-operatively | Post-Operative Day 1 | Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Opioid Consumption | PACU to postoperative day 3 | Reported in mg oral morphine equivalents (OME); measured from PACU through postoperative day 3 |
| Quality of Recovery Score (QoR) | Post-Operative Day 1 | 15 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Single-shot Interscalene Blockade Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg). | 39 |
| Continuous Interscalene Nerve Blockade Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.
Bupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours. | 44 |
| Total | 83 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine Single-shot Interscalene Blockade | Continuous Interscalene Nerve Blockade | Total |
|---|---|---|---|
| Age, Continuous | 72 years | 69 years | 71 years |
| ASA Score ASA 1 | 1 participants | 0 participants | 1 participants |
| ASA Score ASA 2 | 20 participants | 26 participants | 46 participants |
| ASA Score ASA 3 | 18 participants | 18 participants | 36 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 37 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 44 |
| other Total, other adverse events | 0 / 39 | 7 / 44 |
| serious Total, serious adverse events | 0 / 39 | 0 / 44 |
Outcome results
Primary
Pain Intensity Score at Rest at 24 Hours Post-operatively
Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.
Time frame: Post-Operative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine Single-shot Interscalene Blockade | Pain Intensity Score at Rest at 24 Hours Post-operatively | 1 units on a scale |
| Continuous Interscalene Nerve Blockade | Pain Intensity Score at Rest at 24 Hours Post-operatively | 1 units on a scale |
Secondary
Cumulative Opioid Consumption
Reported in mg oral morphine equivalents (OME); measured from PACU through postoperative day 3
Time frame: PACU to postoperative day 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine Single-shot Interscalene Blockade | Cumulative Opioid Consumption | 30.0 mg oral morphine equivalents |
| Continuous Interscalene Nerve Blockade | Cumulative Opioid Consumption | 15.0 mg oral morphine equivalents |
Secondary
Quality of Recovery Score (QoR)
15 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Time frame: Post-Operative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine Single-shot Interscalene Blockade | Quality of Recovery Score (QoR) | 126.0 score on a scale |
| Continuous Interscalene Nerve Blockade | Quality of Recovery Score (QoR) | 124.0 score on a scale |