Pain
Conditions
Keywords
Pain control, liposomal bupivacaine, exparel, shoulder arthroplasty
Brief summary
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares pain control and opioid consumption in patients undergoing shoulder arthroplasty between patients receiving liposomal bupivacaine and those who underwent a preoperative inter-scalene nerve block.
Detailed description
Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All patients over age eighteen and scheduled for primary shoulder arthroplasty (SA) a three fellowship trained surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy. Liposomal Bupivacaine has a refrigerated shelf life of one month the investigational facility. Patients will be sequentially recruited into the randomization process. Liposomal Bupivacaine will be held by the Henry Ford hospital pharmacy up to one month prior to planned shoulder arthroplasty in anticipation of surgery on eligible patients. The sterile solutions will be delivered to and kept by the inpatient clinical pharmacy until the date of surgery and delivered to the operating room at the beginning of a surgical case. The current dose of Liposomal Bupivacaine has been chosen based on previously published data of local infiltrative analgesia with Liposomal Bupivacaine and one published study on Liposomal Bupivacaine efficacy. The week prior to surgery, patients will be randomized to receive Local infiltration anesthesia (LIA) with Liposomal Bupivacaine, or Inter-scalene nerve block (INB) using a computer generated sequence. The results of randomization will be securely delivered to the anesthesiologist and the surgeon the week prior. The anesthesiologist will view the assigned group to determine if a preoperative INB will be given. Depending on the randomization group either an Liposomal Bupivacaine solution will be delivered to the operating room for local infiltration or the anesthesiologist will perform a preoperative INB. Patients in the Liposomal Bupivacaine group will receive LIA with 10cc(133mg) of Liposomal Bupivacaine solution dissolved in 20cc of sterile saline before wound closure. The solution will be applied to the wound bed, muscles, and periosteum. The solution will be left unperturbed for five minutes. Thereafter the solution will be suctioned from the wound and the shoulder joint. Incisions will be closed in typical fashion and the wound dressed.The tourniquet will be deflated. Patients in the INB will receive postoperative ultrasound guided INB. Experienced anesthesiologists will apply all INBs in this study. Following the procedure pain will be accessed subjectively through visual analog scale and numeric rating scale pain scores, pain diaries given to the patient to record at home, pain summary scores at follow up visits and objectively through narcotic pain requirement. A blind observer will also access outcomes. Planned Data Analysis: Means and standard deviations, as well as medians and interquartile ranges will be computed for pain scores.These outcomes will be compared by Wilcoxon rank sum tests. The amount of pain medication and pain scores will be compared by Wilcoxon rank sum tests.
Interventions
DRUGLiposomal bupivacaine
Local infiltration of liposomal bupivacaine
PROCEDUREInter-scalene nerve block
Pre-operative inter-scalene nerve block
DRUGRopivacaine
Ropivicaine was used for the inter-scalene nerve block.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients over the age of 18 scheduled for primary shoulder arthroplasty by three fellowship trained surgeons will be eligible for inclusion
Exclusion criteria
* Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Levels | four days postoperatively | Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalents | four days postoperatively | Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Liposomal bupivacaine: Local infiltration of liposomal bupivacaine | 26 |
| Inter-scalene Nerve Block Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Inter-scalene nerve block: Pre-operative inter-scalene nerve block
Ropivacaine: Ropivicaine was used for the inter-scalene nerve block. | 31 |
| Total | 57 |
Baseline characteristics
| Characteristic | Inter-scalene Nerve Block | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 20 Participants | 47 Participants |
| Age, Continuous | 67.1 years | 69.4 years | 67.8 years |
| Region of Enrollment United States | 31 participants | 26 participants | 57 participants |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 31 |
| serious Total, serious adverse events | 0 / 26 | 1 / 31 |
Outcome results
Primary
Pain Levels
Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.
Time frame: four days postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Pain Levels | Mean Pain score Day 0 | 4.8 units on a scale | Standard Deviation 1.8 |
| Liposomal Bupivacaine | Pain Levels | Mean Pain score Day 1 | 4.7 units on a scale | Standard Deviation 2.3 |
| Liposomal Bupivacaine | Pain Levels | Mean Pain score Day 2 | 4.3 units on a scale | Standard Deviation 2.5 |
| Liposomal Bupivacaine | Pain Levels | Mean Pain score Day 3 | 4.1 units on a scale | Standard Deviation 2 |
| Inter-scalene Nerve Block | Pain Levels | Mean Pain score Day 3 | 4.3 units on a scale | Standard Deviation 2.1 |
| Inter-scalene Nerve Block | Pain Levels | Mean Pain score Day 0 | 4.0 units on a scale | Standard Deviation 1.8 |
| Inter-scalene Nerve Block | Pain Levels | Mean Pain score Day 2 | 3.6 units on a scale | Standard Deviation 1.7 |
| Inter-scalene Nerve Block | Pain Levels | Mean Pain score Day 1 | 4.0 units on a scale | Standard Deviation 1.7 |
Comparison: Our hypothesis was that in patients undergoing shoulder arthroplasty, treatment with LB would lead to no significant differences in average daily pain scores. A power analysis was performed prior to the study to assess the primary hypothesis that a significant difference in average daily pain of 13mm on VAS will not be found between the INB and LB groups. With a power of 80% (beta level = 0.80, alpha level = 0.05), a sample size of 25 patients per group was obtainedp-value: <0.05t-test, 2 sided
Secondary
Morphine Equivalents
Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.
Time frame: four days postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Morphine Equivalents | Mean Morphine equivalents used Day 0 | 14.8 mg of morphine equivalent | Standard Deviation 9.2 |
| Liposomal Bupivacaine | Morphine Equivalents | Mean Morphine equivalents used Day 1 | 8.9 mg of morphine equivalent | Standard Deviation 9.7 |
| Liposomal Bupivacaine | Morphine Equivalents | Mean Morphine equivalents used Day 2 | 12.3 mg of morphine equivalent | Standard Deviation 16.9 |
| Liposomal Bupivacaine | Morphine Equivalents | Mean Morphine equivalents used Day 3 | 2.8 mg of morphine equivalent | Standard Deviation 4.1 |
| Inter-scalene Nerve Block | Morphine Equivalents | Mean Morphine equivalents used Day 3 | 2.2 mg of morphine equivalent | Standard Deviation 6.1 |
| Inter-scalene Nerve Block | Morphine Equivalents | Mean Morphine equivalents used Day 0 | 21.4 mg of morphine equivalent | Standard Deviation 11.3 |
| Inter-scalene Nerve Block | Morphine Equivalents | Mean Morphine equivalents used Day 2 | 5.2 mg of morphine equivalent | Standard Deviation 10.8 |
| Inter-scalene Nerve Block | Morphine Equivalents | Mean Morphine equivalents used Day 1 | 9.1 mg of morphine equivalent | Standard Deviation 11.4 |