Shoulder Arthroplasty
Conditions
Keywords
Shoulder Replacement Surgery, Interscalene Nerve Block, Liposomal Bupivacaine, Shoulder pain, Regional anesthesia, Brachial plexus blockade
Brief summary
The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.
Detailed description
The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.
Interventions
DRUGLiposomal bupivacaine
Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
DRUGBupivacaine with adjuvants
Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All patients undergoing total shoulder arthroplasty (not a reverse) * Age ≥ 18 years * Ability to understand and the willingness to sign an IRB-approved informed consent document. * ASA patient status I-III patients * Weight Greater than or equal to 50 kg
Exclusion criteria
* Contraindications to an interscalene block or phrenic blockade * Infection at injection site * Pre-existing neurological dysfunction affecting the operative extremity * Chronic pain diagnosis or opioid use \>40mg oxycodone daily equivalents or use of long-acting opioids * BMI \>40 * Uncontrolled diabetes (A1c \>8.0) * Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery * Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.) * Patients who are wards of the state * History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine. * Patients with moderate-severe hepatic or renal impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Scores for the First 48 Hours | At 48 hours postoperatively | Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Consumption for the First 48 Hours | up to 48 hours | Morphine milligram equivalents (MME) over a 48 hour period |
| Satisfaction With Surgical Experience | at 48 hours | Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine ISB Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine) | 12 |
| Bupivacaine With Adjuvants ISB Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine ISB | Bupivacaine With Adjuvants ISB | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 7 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 11 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 9 Participants | 19 Participants |
| Region of Enrollment United States | 12 participants | 13 participants | 25 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
Primary
Average Pain Scores for the First 48 Hours
Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.
Time frame: At 48 hours postoperatively
Population: The software interface in this website will not allow for AUC as an acceptable outcome to satisfy field entries. Therefore, here the AUC is not reported here, but rather then mean and standard deviation are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine ISB | Average Pain Scores for the First 48 Hours | 3.2 units on a scale | Standard Deviation 2 |
| Bupivacaine With Adjuvants ISB | Average Pain Scores for the First 48 Hours | 3.6 units on a scale | Standard Deviation 2.4 |
p-value: 0.14Wilcoxon (Mann-Whitney)
Secondary
Postoperative Opioid Consumption for the First 48 Hours
Morphine milligram equivalents (MME) over a 48 hour period
Time frame: up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine ISB | Postoperative Opioid Consumption for the First 48 Hours | 22.9 Morphine milligram equivalents (MME) | Standard Deviation 20.6 |
| Bupivacaine With Adjuvants ISB | Postoperative Opioid Consumption for the First 48 Hours | 28.5 Morphine milligram equivalents (MME) | Standard Deviation 23 |
Secondary
Satisfaction With Surgical Experience
Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction
Time frame: at 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine ISB | Satisfaction With Surgical Experience | 4.75 units on a scale | Standard Deviation 0.45 |
| Bupivacaine With Adjuvants ISB | Satisfaction With Surgical Experience | 3.46 units on a scale | Standard Deviation 1.56 |