Rotator Cuff Tear, Shoulder Pain
Conditions
Keywords
Exparel, Liposomal Bupivacaine, Arthroscopic Shoulder Surgery
Brief summary
The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.
Interventions
DRUGLiposomal bupivacaine
liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
DRUGBupivacaine 0.25%
20 cc of bupivacaine 0.25%
Sponsors
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English speaking adults (age \>17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.
Exclusion criteria
* Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (\< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | Post op Day 1, post op Day 2, post op day 3, post op 1 week | Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory and Motor Block | at 20 min and at 1 hour | Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function. |
| Time to First Pain Medicine | 72 hours | — |
| Quality of Analgesia | Post op Day 1, post op Day 2, post op day 3, post op 1 week | The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain. |
| Incidence of Postoperative Nausea and Vomiting | 72 hours | — |
| Sleep Quality | Post op Day 1, post op Day 2, post op day 3, post op 1 week | scale of 0-10, 0=horrible, up all night; 10=perfect sleep |
| Time to Discharge Home | 72 hours | data not collected |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) | 20 |
| Bupivacaine 0.25% 20 cc of bupivacaine 0.25% | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | Bupivacaine 0.25% | Total |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 9.55 | 54.69 years STANDARD_DEVIATION 9.45 | 55.1 years STANDARD_DEVIATION 9.55 |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 1 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
Total Opioid Consumption
Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.
Time frame: Post op Day 1, post op Day 2, post op day 3, post op 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Total Opioid Consumption | Post op Day 1 | 2 number of percocet tabs | Standard Deviation 1.53 |
| Liposomal Bupivacaine | Total Opioid Consumption | Post op Day 2 | 1.94 number of percocet tabs | Standard Deviation 1.47 |
| Liposomal Bupivacaine | Total Opioid Consumption | Post op Day 3 | 2.06 number of percocet tabs | Standard Deviation 2.01 |
| Liposomal Bupivacaine | Total Opioid Consumption | Post Op 1 Week | 1.61 number of percocet tabs | Standard Deviation 1.61 |
| Bupivacaine 0.25% | Total Opioid Consumption | Post Op 1 Week | 1.13 number of percocet tabs | Standard Deviation 2.03 |
| Bupivacaine 0.25% | Total Opioid Consumption | Post op Day 1 | 2.75 number of percocet tabs | Standard Deviation 2.96 |
| Bupivacaine 0.25% | Total Opioid Consumption | Post op Day 3 | 3.63 number of percocet tabs | Standard Deviation 3.7 |
| Bupivacaine 0.25% | Total Opioid Consumption | Post op Day 2 | 3.33 number of percocet tabs | Standard Deviation 3.61 |
Secondary
Incidence of Postoperative Nausea and Vomiting
Time frame: 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine | Incidence of Postoperative Nausea and Vomiting | 33.33 percentage of participants |
| Bupivacaine 0.25% | Incidence of Postoperative Nausea and Vomiting | 36.84 percentage of participants |
Secondary
Quality of Analgesia
The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain.
Time frame: Post op Day 1, post op Day 2, post op day 3, post op 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Quality of Analgesia | Post op Day 2 | 4.9 units on a scale | Standard Deviation 3.4 |
| Liposomal Bupivacaine | Quality of Analgesia | Post op Day 1 | 5.23 units on a scale | Standard Deviation 3.5 |
| Liposomal Bupivacaine | Quality of Analgesia | Post op Day 3 | 5.18 units on a scale | Standard Deviation 2.77 |
| Liposomal Bupivacaine | Quality of Analgesia | Post Op 1 Week | 4.08 units on a scale | Standard Deviation 2.88 |
| Bupivacaine 0.25% | Quality of Analgesia | Post Op 1 Week | 3.66 units on a scale | Standard Deviation 2.46 |
| Bupivacaine 0.25% | Quality of Analgesia | Post op Day 1 | 6.4 units on a scale | Standard Deviation 2.15 |
| Bupivacaine 0.25% | Quality of Analgesia | Post op Day 2 | 6.13 units on a scale | Standard Deviation 2.66 |
| Bupivacaine 0.25% | Quality of Analgesia | Post op Day 3 | 5.14 units on a scale | Standard Deviation 3.08 |
Secondary
Sensory and Motor Block
Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function.
Time frame: at 20 min and at 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Sensory and Motor Block | Sensory block at 20 min prior to surgery | 1.6 units on a scale | Standard Deviation 0.43 |
| Liposomal Bupivacaine | Sensory and Motor Block | Motor block at 20 min prior to surgery | 2.8 units on a scale | Standard Deviation 0.43 |
| Liposomal Bupivacaine | Sensory and Motor Block | Sensory block at 1 hour after arrival to PACU | 1.78 units on a scale | Standard Deviation 2.77 |
| Bupivacaine 0.25% | Sensory and Motor Block | Sensory block at 20 min prior to surgery | 1.31 units on a scale | Standard Deviation 0.42 |
| Bupivacaine 0.25% | Sensory and Motor Block | Motor block at 20 min prior to surgery | 2.33 units on a scale | Standard Deviation 0.7 |
| Bupivacaine 0.25% | Sensory and Motor Block | Sensory block at 1 hour after arrival to PACU | 1.08 units on a scale | Standard Deviation 2.08 |
Secondary
Sleep Quality
scale of 0-10, 0=horrible, up all night; 10=perfect sleep
Time frame: Post op Day 1, post op Day 2, post op day 3, post op 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Sleep Quality | Post op Day 3 | 6.75 units on a scale | Standard Deviation 2.11 |
| Liposomal Bupivacaine | Sleep Quality | Post op Day 1 | 5.06 units on a scale | Standard Deviation 3.23 |
| Liposomal Bupivacaine | Sleep Quality | Post Op 1 Week | 7.8 units on a scale | Standard Deviation 1.67 |
| Liposomal Bupivacaine | Sleep Quality | Post op Day 2 | 6.58 units on a scale | Standard Deviation 2.74 |
| Bupivacaine 0.25% | Sleep Quality | Post Op 1 Week | 7.65 units on a scale | Standard Deviation 2.49 |
| Bupivacaine 0.25% | Sleep Quality | Post op Day 2 | 6 units on a scale | Standard Deviation 2.29 |
| Bupivacaine 0.25% | Sleep Quality | Post op Day 3 | 6.3 units on a scale | Standard Deviation 2.46 |
| Bupivacaine 0.25% | Sleep Quality | Post op Day 1 | 3.86 units on a scale | Standard Deviation 2.37 |
Secondary
Time to Discharge Home
data not collected
Time frame: 72 hours
Secondary
Time to First Pain Medicine
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Time to First Pain Medicine | 1148 minutes | Standard Deviation 1227.59 |
| Bupivacaine 0.25% | Time to First Pain Medicine | 702.89 minutes | Standard Deviation 273.06 |