Arthropathy Shoulder
Conditions
Brief summary
The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.
Detailed description
This is a prospective, single-blinded randomized clinical trial comparing outcomes in patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine versus standard bupivacaine alone. Once consent is obtained, baseline characteristics will be recorded and patients will be randomized to intervention or control. Following surgery, patients will be followed until their 3-week post-operative visit. The primary outcome measure will be the mean difference in patient pain scores over the first 72 hours post-operatively between two groups. Secondary outcomes will include: (1) Total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks (2) Patient perceived duration of block determined as the time patient perceives complete resolution of block (3) Patient satisfaction with pain control at 72 hours, 3 weeks post-operatively and patient reported outcome measures (SANE, SST, ASES, VR-12) at 3 weeks post-operatively.
Interventions
DRUGLiposomal Bupivacaine
Interscalene Nerve Blocks
DRUGBupivacaine Hydrochloride
Interscalene Nerve Blocks
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The pharmacist will prepare, and dispense the medication sequentially. Medication syringes will be blinded utilizing black tape. Patients, care team in recovery, study team members collecting and recording data, and statisticians will be blinded to randomization assignment. All patients will be documented in EMR as receiving liposomal bupivacaine to ensure the blind is maintained and to ensure that safety features in the EMR for all patients receiving liposomal bupivacaine are activated. Further, all additional standard precautionary measures (e.g. wrist band) will be similarly implemented for both patient groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients (\>18 years of age) * Patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy * Cognitively intact with the ability to give informed consent as outlined by our institutional review board. * Patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events
Exclusion criteria
* Non-elective cases * Infection, tumor, trauma * Weight \< 50 kg * Patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics * Patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl * Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively * Concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder) * Severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests. * Pregnancy * Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 \< 50% predicted, and 02 dependence)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Scores | 72 hours post-operatively | Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | Measured at 72 hours and at 3 weeks post-operatively | Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks |
| Time to Cessation of Nerve Blockade | 4, 8, 12, 16, 20, 24, and 28 hours post-operatively | Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site. |
| Satisfaction With Pain Control Using Satisfaction Scale | Measured at 72 hours and at three weeks post-operatively | Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Administered utilizing ultrasound guidance by an anesthesiologist. Study patients received 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Liposomal Bupivacaine: Interscalene Nerve Blocks | 52 |
| Plain Bupivacaine Peripheral nerve blocks were performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride was utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block was utilized. Further, 8 mg (2 ml) IV dexamethasone was administered concomitantly at the time of the block.
Bupivacaine Hydrochloride: Interscalene Nerve Blocks | 52 |
| Total | 104 |
Baseline characteristics
| Characteristic | Plain Bupivacaine | Total | Liposomal Bupivacaine |
|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 10.15 | 69.6 years STANDARD_DEVIATION 8.62 | 70.0 years STANDARD_DEVIATION 6.84 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 52 participants | 104 participants | 52 participants |
| Sex: Female, Male Female | 24 Participants | 46 Participants | 22 Participants |
| Sex: Female, Male Male | 28 Participants | 58 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
Patient Pain Scores
Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.
Time frame: 72 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Patient Pain Scores | 4.0 score on a scale | Standard Deviation 2.57 |
| Plain Bupivacaine | Patient Pain Scores | 2.8 score on a scale | Standard Deviation 1.88 |
p-value: 0.0197Wilcoxon (Mann-Whitney)
Secondary
Opioid Consumption
Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks
Time frame: Measured at 72 hours and at 3 weeks post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Opioid Consumption | 72 hours | 45.6 morphine milligram equivalent (MME) | Standard Deviation 37.55 |
| Liposomal Bupivacaine | Opioid Consumption | 3 weeks | 133.9 morphine milligram equivalent (MME) | Standard Deviation 110.52 |
| Plain Bupivacaine | Opioid Consumption | 72 hours | 56.2 morphine milligram equivalent (MME) | Standard Deviation 35.43 |
| Plain Bupivacaine | Opioid Consumption | 3 weeks | 150.9 morphine milligram equivalent (MME) | Standard Deviation 138.4 |
Comparison: 72 hoursp-value: 0.584Wilcoxon (Mann-Whitney)
Comparison: 3 weeksp-value: 0.58Wilcoxon (Mann-Whitney)
Secondary
Satisfaction With Pain Control Using Satisfaction Scale
Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management.
Time frame: Measured at 72 hours and at three weeks post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Satisfaction With Pain Control Using Satisfaction Scale | 72 hours | 6.6 units on a scale | Standard Deviation 2.74 |
| Liposomal Bupivacaine | Satisfaction With Pain Control Using Satisfaction Scale | 3 weeks | 7.5 units on a scale | Standard Deviation 2.52 |
| Plain Bupivacaine | Satisfaction With Pain Control Using Satisfaction Scale | 72 hours | 6.9 units on a scale | Standard Deviation 2.64 |
| Plain Bupivacaine | Satisfaction With Pain Control Using Satisfaction Scale | 3 weeks | 7.8 units on a scale | Standard Deviation 2.23 |
Comparison: 72 hoursp-value: 0.7018Wilcoxon (Mann-Whitney)
Comparison: Week 3p-value: 0.5327Wilcoxon (Mann-Whitney)
Secondary
Time to Cessation of Nerve Blockade
Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.
Time frame: 4, 8, 12, 16, 20, 24, and 28 hours post-operatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liposomal Bupivacaine | Time to Cessation of Nerve Blockade | 4 hours | 16 Participants |
| Liposomal Bupivacaine | Time to Cessation of Nerve Blockade | 20 hours | 43 Participants |
| Liposomal Bupivacaine | Time to Cessation of Nerve Blockade | 12 hours | 38 Participants |
| Liposomal Bupivacaine | Time to Cessation of Nerve Blockade | 24 hours | 46 Participants |
| Liposomal Bupivacaine | Time to Cessation of Nerve Blockade | 8 hours | 31 Participants |
| Liposomal Bupivacaine | Time to Cessation of Nerve Blockade | 28 hours | 47 Participants |
| Liposomal Bupivacaine | Time to Cessation of Nerve Blockade | 16 hours | 43 Participants |
| Plain Bupivacaine | Time to Cessation of Nerve Blockade | 28 hours | 45 Participants |
| Plain Bupivacaine | Time to Cessation of Nerve Blockade | 8 hours | 19 Participants |
| Plain Bupivacaine | Time to Cessation of Nerve Blockade | 12 hours | 28 Participants |
| Plain Bupivacaine | Time to Cessation of Nerve Blockade | 16 hours | 35 Participants |
| Plain Bupivacaine | Time to Cessation of Nerve Blockade | 20 hours | 41 Participants |
| Plain Bupivacaine | Time to Cessation of Nerve Blockade | 24 hours | 44 Participants |
| Plain Bupivacaine | Time to Cessation of Nerve Blockade | 4 hours | 12 Participants |
p-value: 0.11Log Rank