Total Shoulder Arthroplasty, Shoulder Osteoarthritis
Conditions
Keywords
Liposomal bupivacaine, Dexamethasone, Interscalene catheter, Interscalene single shot
Brief summary
Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia or as a sole primary technique comes to one's rescue. Interscalene block either as single shot or as a catheter is an established modality for effective analgesia which facilitates early mobilization helping in physical therapy and early discharge. With the help of local anesthetic injected as a single shot, analgesia usually lasts less than 24 hours. Recent research in regional anesthesia is advancing towards adjuvants which will prolong the duration of local anesthesia. This has introduced the concept of multimodal perineural analgesia (MMPNA) whereby multiple agents with differing mechanisms of action are used with the goal of providing perineural analgesia while avoiding exposure to high and potentially toxic levels of individual agents. Some of the commonly used adjuvants in clinical studies are fentanyl, buprenorphine, morphine, tramadol, magnesium, epinephrine, ketamine, non-steroidal anti-inflammatory drug (NSAID), midazolam, parecoxib, ketorolac, clonidine, dexmedetomidine, dexamethasone, neostigmine and potassium. They find a distinct place in wide spread clinical practice as an off-label use. Steroids have a long history of safe use in epidural space for treatment of radicular pain due to nerve irritation. Dexamethasone is used routinely as a part of anti- emetic prophylaxis and anti-inflammatory effect. Methyl prednisone was the first steroid to be used as an adjuvant. Dexamethasone was first used as an adjuvant in 2003. It has been hypothesized that steroids induce a degree of vasoconstriction, thereby reducing local anesthetic absorption, tend to have an opioid sparing effect. Another theory suggests that it increases the activity of inhibitory potassium channels on nociceptive C-fibers (via glucocorticoid receptors), thus decreasing their activity. Several studies have demonstrated promising results with the use of 8mg of perineural dexamethasone. No neuronal injury has been reported in in vivo studies. Though there are several studies which report usage of dexamethasone in varying doses of 2mg to 8mg, the optimal effective dose of dexamethasone as an adjuvant for nerve block remains unknown. Some studies have suggested perineural is more effective than IV as an adjuvant . Liposomal bupivacaine, a formulation where bupivacaine is encapsulated into multivesicular liposomes, making it a slow and controlled release from the liposomes, was originally indicated for wound infiltration at the surgical site to provide post-surgical analgesia. Studies have demonstrated efficacy up to 24 hours in femoral nerve block in total knee arthroplasty. Recent approval of liposomal bupivacaine in interscalene block for shoulder surgeries by FDA opens an arena unexplored in the world of regional anesthesia. Current opioid epidemic, a crisis in health care forces healthcare providers to consider alternate analgesic modalities without compromising patient comfort. Regional anesthesia has revolutionized peri-operative pain management by avoiding opioids and their side effects. Use of adjuvants to the current regional techniques holds promise in postsurgical analgesia. The researchers propose to compare the analgesic efficacy of liposomal bupivacaine to bupivacaine with dexamethasone as an adjuvant in interscalene block with catheters for shoulder surgeries. Till date, there is not a single study comparing the three in current literature.
Detailed description
There have been several studies demonstrating efficacy of dexamethasone in prolonging the analgesic effect when administered both perineurally and intra-venously as an adjuvant to local anesthesia demonstrating a dose effect relationship. Liposomal bupivacaine has shown promising results in total knee arthroplasty and there are a limited number of studies demonstrating efficacy in total shoulder arthroplasty. If by comparing dexamethasone as an adjuvant to bupivacaine and liposomal formulation is deciphered, it can help in avoiding costs associated with liposomal bupivacaine extending post-operative analgesia avoiding narcotics and reducing health care costs. And comparing the two to the standard catheters helps us understand if they have a role in pain management in the future.
Interventions
rescue catheters attached to a PCA pump
10 cc
1 cc of 4mg
0.5% bupivacaine
Sponsors
Study design
Eligibility
Inclusion criteria
* All patients between age 18-80 years undergoing elective primary total shoulder arthroplasty procedure. * All patients who speak read and understand English will be included for follow up purposes.
Exclusion criteria
* Patient refusal * ASA 5 * presence of coagulopathy * severe lung disease * contralateral diaphragmatic palsy * insulin-dependent diabetes * hepatic disease/failure * kidney disease/failure * pregnancy * chronic opioid use (defined as opioid use for \>3 months), or allergy to any of the study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Score for Pain | at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours | Numerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Narcotic Consumption | hospital stay, up to 48 hours | Total narcotic consumption in mg morphine equivalents (MME) during hospital stay |
| Arm Weakness | at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours | Arm weakness as assessed by flexion and extension at wrist -- total scale from 1 to 10, with 10 being most weakness |
| Arm Numbness | at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours | Arm numbness assessed by the sensation at deltoid area. Sensation total scale from 1 to 10, with higher number indicating most sensation. |
| Time of Analgesia Duration | Day 1 | The duration for which the patient has no pain on Day 1 |
| Time of Motor Recovery | Day 1 | Time of motor recovery on Day 1 |
| Sensory Intact | at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours | Sensory testing by using pinprick in the region of C5 dermatome. Scale from 1 to 10, with higher score indicating more sensation. |
| Time to First Analgesic Request | Day 1 | Time to first analgesic request on Day 1 |
| PACU Length of Stay | Day 1 | Post-anesthesia Care Unit length of stay in hours on Day 1 |
| Hospital Length of Stay | up to 3 days | Length of stay for duration of hospital admission |
| Number of Complication Events | up to 3 days | Number of complications - any associated complications like nausea, vomiting, dizziness, horner's syndrome, hoarseness and dyspnea |
| Number of Participants With Quality of Sleep Rating | average of 3 days | Patient to rate their quality of sleep as good, average, or bad |
| Number of Participants With Patient's Satisfaction | during the hospital stay, up to 3 days | Number of Participants with Patient satisfaction. Patients were asked if they were satisfied. |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) | baseline and one week post-op | PROMIS global assessment assesses physical and mental activities of daily living scored from 0 (poor) to 5 (excellent) at first post-operative visit as compared to baseline. Each scale from 0-100, higher score indicates better health outcomes. |
| Hand Strength | at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours | Hand strength assessed by using dynamometer, a device for measuring the amount of static force that can squeeze around a dynamometer, in kilograms. |
Countries
United States
Participant flow
Recruitment details
Recruitment from 2018 to 2022
Pre-assignment details
There were 155 eligible participants and 90 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Interscalene Catheter Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene catheter: rescue catheters attached to a PCA pump
Bupivacaine: 0.5% bupivacaine | 24 |
| Interscalene With Bupivacaine and Dexamethasone Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Dexamethasone: 1 cc of 4mg
Bupivacaine: 0.5% bupivacaine | 24 |
| Interscalene Single Shot With Liposomal Bupivacaine Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion.
Liposomal bupivacaine: 10 cc | 24 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | did not receive allocated intervention | 3 | 3 | 4 |
| Overall Study | Protocol Violation | 4 | 2 | 2 |
Baseline characteristics
| Characteristic | Interscalene Catheter | Interscalene With Bupivacaine and Dexamethasone | Interscalene Single Shot With Liposomal Bupivacaine | Total |
|---|---|---|---|---|
| Age, Continuous | 69.08 years STANDARD_DEVIATION 6.23 | 71.75 years STANDARD_DEVIATION 6.58 | 68 years STANDARD_DEVIATION 8.5 | 69.61 years STANDARD_DEVIATION 7.25 |
| Current Smoker | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 19 Participants | 21 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Level of Education Bachelor | 7 Participants | 8 Participants | 10 Participants | 25 Participants |
| Level of Education Graduate | 6 Participants | 6 Participants | 8 Participants | 20 Participants |
| Level of Education High School | 10 Participants | 9 Participants | 5 Participants | 24 Participants |
| Level of Education Under High School | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Number of Participant Employed | 13 Participants | 3 Participants | 8 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 13 Participants | 17 Participants | 48 Participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 13 Participants | 44 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 11 Participants | 28 Participants |
| Side of Surgery Left | 12 Participants | 11 Participants | 9 Participants | 32 Participants |
| Side of Surgery Right | 12 Participants | 13 Participants | 15 Participants | 40 Participants |
| The American Society of Anesthesiologists (ASA) Physical Status Classification System ASA I | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| The American Society of Anesthesiologists (ASA) Physical Status Classification System ASA II | 8 Participants | 18 Participants | 12 Participants | 38 Participants |
| The American Society of Anesthesiologists (ASA) Physical Status Classification System ASA III | 15 Participants | 6 Participants | 12 Participants | 33 Participants |
| Type of Shoulder Replacement Anatomic | 10 Participants | 13 Participants | 12 Participants | 35 Participants |
| Type of Shoulder Replacement Reverse | 14 Participants | 11 Participants | 12 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Numerical Rating Score for Pain
Numerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain.
Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interscalene Catheter | Numerical Rating Score for Pain | 6 hours | 0.00 score on a scale |
| Interscalene Catheter | Numerical Rating Score for Pain | 12 hours | 0.00 score on a scale |
| Interscalene Catheter | Numerical Rating Score for Pain | 18 hours | 2.00 score on a scale |
| Interscalene Catheter | Numerical Rating Score for Pain | 24 hours | 2.50 score on a scale |
| Interscalene Catheter | Numerical Rating Score for Pain | 36 hours | 3.00 score on a scale |
| Interscalene Catheter | Numerical Rating Score for Pain | 48 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Numerical Rating Score for Pain | 48 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Numerical Rating Score for Pain | 6 hours | 0.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Numerical Rating Score for Pain | 24 hours | 3.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Numerical Rating Score for Pain | 36 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Numerical Rating Score for Pain | 12 hours | 0.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Numerical Rating Score for Pain | 18 hours | 5.50 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Numerical Rating Score for Pain | 12 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Numerical Rating Score for Pain | 18 hours | 0.50 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Numerical Rating Score for Pain | 48 hours | 2.50 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Numerical Rating Score for Pain | 24 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Numerical Rating Score for Pain | 6 hours | 0.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Numerical Rating Score for Pain | 36 hours | 2.00 score on a scale |
Arm Numbness
Arm numbness assessed by the sensation at deltoid area. Sensation total scale from 1 to 10, with higher number indicating most sensation.
Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interscalene Catheter | Arm Numbness | 24 hours | 2.00 score on a scale |
| Interscalene Catheter | Arm Numbness | 18 hours | 2.00 score on a scale |
| Interscalene Catheter | Arm Numbness | 6 hours | 1.00 score on a scale |
| Interscalene Catheter | Arm Numbness | 12 hours | 2.00 score on a scale |
| Interscalene Catheter | Arm Numbness | 36 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Numbness | 18 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Numbness | 6 hours | 1.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Numbness | 12 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Numbness | 24 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Numbness | 36 hours | 3.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Numbness | 36 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Numbness | 24 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Numbness | 6 hours | 1.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Numbness | 18 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Numbness | 12 hours | 2.00 score on a scale |
Arm Weakness
Arm weakness as assessed by flexion and extension at wrist -- total scale from 1 to 10, with 10 being most weakness
Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interscalene Catheter | Arm Weakness | 24 hours | 4.00 score on a scale |
| Interscalene Catheter | Arm Weakness | 18 hours | 3.00 score on a scale |
| Interscalene Catheter | Arm Weakness | 6 hours | 2.00 score on a scale |
| Interscalene Catheter | Arm Weakness | 12 hours | 2.00 score on a scale |
| Interscalene Catheter | Arm Weakness | 36 hours | 5.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Weakness | 18 hours | 4.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Weakness | 6 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Weakness | 12 hours | 3.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Weakness | 24 hours | 5.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Arm Weakness | 36 hours | 5.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Weakness | 36 hours | 5.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Weakness | 24 hours | 5.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Weakness | 6 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Weakness | 18 hours | 4.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Arm Weakness | 12 hours | 4.00 score on a scale |
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
PROMIS global assessment assesses physical and mental activities of daily living scored from 0 (poor) to 5 (excellent) at first post-operative visit as compared to baseline. Each scale from 0-100, higher score indicates better health outcomes.
Time frame: baseline and one week post-op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interscalene Catheter | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Pre-Physical, baseline | 41.98 score on a scale | Standard Deviation 9.88 |
| Interscalene Catheter | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Post-Physical, one week post-op | 44.44 score on a scale | Standard Deviation 9.57 |
| Interscalene Catheter | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Pre-Mental, baseline | 50.00 score on a scale | Standard Deviation 12.18 |
| Interscalene Catheter | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Post-Mental, one week post-op | 49.75 score on a scale | Standard Deviation 11.51 |
| Interscalene With Bupivacaine and Dexamethasone | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Post-Mental, one week post-op | 52.14 score on a scale | Standard Deviation 10.41 |
| Interscalene With Bupivacaine and Dexamethasone | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Pre-Physical, baseline | 42.42 score on a scale | Standard Deviation 8.83 |
| Interscalene With Bupivacaine and Dexamethasone | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Pre-Mental, baseline | 51.64 score on a scale | Standard Deviation 11.01 |
| Interscalene With Bupivacaine and Dexamethasone | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Post-Physical, one week post-op | 43.55 score on a scale | Standard Deviation 9.52 |
| Interscalene Single Shot With Liposomal Bupivacaine | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Post-Mental, one week post-op | 52.99 score on a scale | Standard Deviation 6.93 |
| Interscalene Single Shot With Liposomal Bupivacaine | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Post-Physical, one week post-op | 45.15 score on a scale | Standard Deviation 8.89 |
| Interscalene Single Shot With Liposomal Bupivacaine | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Pre-Mental, baseline | 51.44 score on a scale | Standard Deviation 8.35 |
| Interscalene Single Shot With Liposomal Bupivacaine | Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Pre-Physical, baseline | 42.19 score on a scale | Standard Deviation 9.26 |
Hand Strength
Hand strength assessed by using dynamometer, a device for measuring the amount of static force that can squeeze around a dynamometer, in kilograms.
Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interscalene Catheter | Hand Strength | 12 hours - Right hand | 14.75 kg |
| Interscalene Catheter | Hand Strength | 18 hours Left hand | 13.95 kg |
| Interscalene Catheter | Hand Strength | 18 hours - Right hand | 16.80 kg |
| Interscalene Catheter | Hand Strength | 24 hours - Right hand | 16.90 kg |
| Interscalene Catheter | Hand Strength | 6 hours - Left hand | 16.90 kg |
| Interscalene Catheter | Hand Strength | 36 hours - Right hand | 13.50 kg |
| Interscalene Catheter | Hand Strength | 24 hours - Left hand | 15.10 kg |
| Interscalene Catheter | Hand Strength | 12 hours - Left hand | 13.50 kg |
| Interscalene Catheter | Hand Strength | 36 hours - Left hand | 16.50 kg |
| Interscalene Catheter | Hand Strength | 6 hours - Right hand | 14.90 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 12 hours - Right hand | 14.50 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 24 hours - Left hand | 19.00 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 6 hours - Right hand | 13.50 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 18 hours - Right hand | 16.35 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 18 hours Left hand | 16.50 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 6 hours - Left hand | 18.00 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 24 hours - Right hand | 19.30 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 36 hours - Left hand | 20.00 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 12 hours - Left hand | 19.00 kg |
| Interscalene With Bupivacaine and Dexamethasone | Hand Strength | 36 hours - Right hand | 20.50 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 36 hours - Left hand | 20.00 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 6 hours - Left hand | 16.35 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 12 hours - Left hand | 16.85 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 18 hours Left hand | 19.50 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 24 hours - Left hand | 20.00 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 36 hours - Right hand | 18.50 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 6 hours - Right hand | 10.00 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 12 hours - Right hand | 12.00 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 18 hours - Right hand | 12.40 kg |
| Interscalene Single Shot With Liposomal Bupivacaine | Hand Strength | 24 hours - Right hand | 17.50 kg |
Hospital Length of Stay
Length of stay for duration of hospital admission
Time frame: up to 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interscalene Catheter | Hospital Length of Stay | 2.75 days |
| Interscalene With Bupivacaine and Dexamethasone | Hospital Length of Stay | 2 days |
| Interscalene Single Shot With Liposomal Bupivacaine | Hospital Length of Stay | 1.75 days |
Number of Complication Events
Number of complications - any associated complications like nausea, vomiting, dizziness, horner's syndrome, hoarseness and dyspnea
Time frame: up to 3 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interscalene Catheter | Number of Complication Events | Nausea | 3 events |
| Interscalene Catheter | Number of Complication Events | Vomiting | 0 events |
| Interscalene Catheter | Number of Complication Events | Dizziness | 2 events |
| Interscalene Catheter | Number of Complication Events | Horners | 2 events |
| Interscalene Catheter | Number of Complication Events | Hoarseness | 1 events |
| Interscalene Catheter | Number of Complication Events | Dyspnea | 0 events |
| Interscalene With Bupivacaine and Dexamethasone | Number of Complication Events | Dyspnea | 0 events |
| Interscalene With Bupivacaine and Dexamethasone | Number of Complication Events | Nausea | 2 events |
| Interscalene With Bupivacaine and Dexamethasone | Number of Complication Events | Horners | 0 events |
| Interscalene With Bupivacaine and Dexamethasone | Number of Complication Events | Hoarseness | 3 events |
| Interscalene With Bupivacaine and Dexamethasone | Number of Complication Events | Vomiting | 0 events |
| Interscalene With Bupivacaine and Dexamethasone | Number of Complication Events | Dizziness | 2 events |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Complication Events | Vomiting | 0 events |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Complication Events | Dizziness | 2 events |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Complication Events | Dyspnea | 0 events |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Complication Events | Horners | 0 events |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Complication Events | Nausea | 1 events |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Complication Events | Hoarseness | 0 events |
Number of Participants With Patient's Satisfaction
Number of Participants with Patient satisfaction. Patients were asked if they were satisfied.
Time frame: during the hospital stay, up to 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interscalene Catheter | Number of Participants With Patient's Satisfaction | 16 Participants |
| Interscalene With Bupivacaine and Dexamethasone | Number of Participants With Patient's Satisfaction | 16 Participants |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Participants With Patient's Satisfaction | 16 Participants |
Number of Participants With Quality of Sleep Rating
Patient to rate their quality of sleep as good, average, or bad
Time frame: average of 3 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interscalene Catheter | Number of Participants With Quality of Sleep Rating | Average | 5 Participants |
| Interscalene Catheter | Number of Participants With Quality of Sleep Rating | Good | 12 Participants |
| Interscalene Catheter | Number of Participants With Quality of Sleep Rating | Bad | 7 Participants |
| Interscalene With Bupivacaine and Dexamethasone | Number of Participants With Quality of Sleep Rating | Average | 6 Participants |
| Interscalene With Bupivacaine and Dexamethasone | Number of Participants With Quality of Sleep Rating | Good | 9 Participants |
| Interscalene With Bupivacaine and Dexamethasone | Number of Participants With Quality of Sleep Rating | Bad | 9 Participants |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Participants With Quality of Sleep Rating | Good | 7 Participants |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Participants With Quality of Sleep Rating | Bad | 10 Participants |
| Interscalene Single Shot With Liposomal Bupivacaine | Number of Participants With Quality of Sleep Rating | Average | 7 Participants |
PACU Length of Stay
Post-anesthesia Care Unit length of stay in hours on Day 1
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interscalene Catheter | PACU Length of Stay | 2.7 hours |
| Interscalene With Bupivacaine and Dexamethasone | PACU Length of Stay | 2.44 hours |
| Interscalene Single Shot With Liposomal Bupivacaine | PACU Length of Stay | 3 hours |
Sensory Intact
Sensory testing by using pinprick in the region of C5 dermatome. Scale from 1 to 10, with higher score indicating more sensation.
Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Interscalene Catheter | Sensory Intact | 24 hours | 2.00 score on a scale |
| Interscalene Catheter | Sensory Intact | 18 hours | 2.00 score on a scale |
| Interscalene Catheter | Sensory Intact | 36 hours | 2.00 score on a scale |
| Interscalene Catheter | Sensory Intact | 12 hours | 2.00 score on a scale |
| Interscalene Catheter | Sensory Intact | 6 hours | 1.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Sensory Intact | 6 hours | 1.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Sensory Intact | 12 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Sensory Intact | 18 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Sensory Intact | 24 hours | 2.00 score on a scale |
| Interscalene With Bupivacaine and Dexamethasone | Sensory Intact | 36 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Sensory Intact | 36 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Sensory Intact | 24 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Sensory Intact | 6 hours | 1.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Sensory Intact | 18 hours | 2.00 score on a scale |
| Interscalene Single Shot With Liposomal Bupivacaine | Sensory Intact | 12 hours | 2.00 score on a scale |
Time of Analgesia Duration
The duration for which the patient has no pain on Day 1
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interscalene Catheter | Time of Analgesia Duration | 6.00 hours |
| Interscalene With Bupivacaine and Dexamethasone | Time of Analgesia Duration | 11.00 hours |
| Interscalene Single Shot With Liposomal Bupivacaine | Time of Analgesia Duration | 8.00 hours |
Time of Motor Recovery
Time of motor recovery on Day 1
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interscalene Catheter | Time of Motor Recovery | 12.00 hours |
| Interscalene With Bupivacaine and Dexamethasone | Time of Motor Recovery | 14.00 hours |
| Interscalene Single Shot With Liposomal Bupivacaine | Time of Motor Recovery | 12.00 hours |
Time to First Analgesic Request
Time to first analgesic request on Day 1
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interscalene Catheter | Time to First Analgesic Request | 1.50 hours |
| Interscalene With Bupivacaine and Dexamethasone | Time to First Analgesic Request | 3.50 hours |
| Interscalene Single Shot With Liposomal Bupivacaine | Time to First Analgesic Request | 2.19 hours |
Total Narcotic Consumption
Total narcotic consumption in mg morphine equivalents (MME) during hospital stay
Time frame: hospital stay, up to 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interscalene Catheter | Total Narcotic Consumption | 30.00 MME |
| Interscalene With Bupivacaine and Dexamethasone | Total Narcotic Consumption | 21.05 MME |
| Interscalene Single Shot With Liposomal Bupivacaine | Total Narcotic Consumption | 13.25 MME |