Osteoarthritis, Arthropathy, Shoulder Pain, Closed Fracture Proximal Humerus, Four Part
Conditions
Brief summary
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements. Each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.
Detailed description
After the decision to proceed with shoulder replacement surgery, patients will be asked to participate in this randomized trial. Consent will be completed after explanation of each treatment group and the data to be collected. Patients will be randomized into one of the two treatment groups by simple randomization into one of two groups: Group 1 will receive interscalene nerve block and group 2 will receive liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site. The surgeon at each site will be trained prior to enrollment on the correct way to perform Exparel injections intraoperatively. Patients in the interscalene nerve block group will be given a single shot block in the preoperative area by a fellowship-trained anesthesiologist. The primary outcome is pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain). Secondary outcomes are postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 hours; VAS pain score at the first postoperative visit ; intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1); duration of stay in the post-anesthesia care unit (PACU); duration of hospital stay; and VAS score for satisfaction with pain control in the hospital and at home, assessed at participants' first postoperative visit. VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).
Interventions
DRUGLiposomal bupivacaine
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Sponsors
University of Texas Southwestern Medical Center
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons. * Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included.
Exclusion criteria
* Allergy to liposomal bupivacaine * Contraindications to the interscalene nerve block such as: * Preexisting neurologic defects * Local anesthetic allergy * Coagulopathy * Contralateral phrenic nerve dysfunction * Severe chronic obstructive pulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain Score at 24 Hours Postoperatively | At 24 hours after surgery | The primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Medication Consumption in Morphine Milligram Equivalents | Up to 4 days postoperatively | We analyzed intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1). This was measured in morphine milligram equivalents. |
| Length of Hospital Stay | At the time of discharge from hospital, Up to 4 days | Duration of stay in hospital (hours) after shoulder replacement surgery. |
| Postoperative Visual Analog Scale (VAS) Pain Scores | Up to first postoperative visit, maximum 30 days | We analyzed postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 hours and at the first postoperative visit. VAS pain scores range from 0 (no pain) to 10 (unbearable pain). |
| Patient Satisfaction With Pain Management | At first postoperative visit, up to 30 days | Visual Analog Scale (VAS) score for satisfaction with pain control in the hospital and at home. This was assessed at subjects' first postoperative visit.VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied). |
| Length of Stay in the Post-anesthesia Care Unit (PACU) | At the time of discharge from PACU, Up to 1 day | Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interscalene Nerve Block Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Interscalene Nerve Block: Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist. | 54 |
| Liposomal Bupivacaine Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon. | 54 |
| Total | 108 |
Baseline characteristics
| Characteristic | Interscalene Nerve Block | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 30 Participants | 67 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 24 Participants | 41 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 10 | 65 years STANDARD_DEVIATION 9 | 67 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 52 Participants | 101 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 13 Participants | 21 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 46 Participants | 40 Participants | 86 Participants |
| Region of Enrollment United States | 54 Participants | 54 Participants | 108 Participants |
| Sex: Female, Male Female | 24 Participants | 23 Participants | 47 Participants |
| Sex: Female, Male Male | 30 Participants | 31 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 54 |
| other Total, other adverse events | 0 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 |
Outcome results
Primary
Visual Analog Scale Pain Score at 24 Hours Postoperatively
The primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).
Time frame: At 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interscalene Nerve Block | Visual Analog Scale Pain Score at 24 Hours Postoperatively | 5.0 score on a scale | Standard Deviation 3 |
| Liposomal Bupivacaine | Visual Analog Scale Pain Score at 24 Hours Postoperatively | 4.9 score on a scale | Standard Deviation 2.7 |
Secondary
Length of Hospital Stay
Duration of stay in hospital (hours) after shoulder replacement surgery.
Time frame: At the time of discharge from hospital, Up to 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interscalene Nerve Block | Length of Hospital Stay | 39 hours | Standard Deviation 20 |
| Liposomal Bupivacaine | Length of Hospital Stay | 36 hours | Standard Deviation 14 |
Secondary
Length of Stay in the Post-anesthesia Care Unit (PACU)
Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.
Time frame: At the time of discharge from PACU, Up to 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interscalene Nerve Block | Length of Stay in the Post-anesthesia Care Unit (PACU) | 102 minutes | Standard Deviation 53 |
| Liposomal Bupivacaine | Length of Stay in the Post-anesthesia Care Unit (PACU) | 139 minutes | Standard Deviation 77 |
Secondary
Opioid Medication Consumption in Morphine Milligram Equivalents
We analyzed intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1). This was measured in morphine milligram equivalents.
Time frame: Up to 4 days postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interscalene Nerve Block | Opioid Medication Consumption in Morphine Milligram Equivalents | Total Intraoperative + Postoperative day 1 | 38 morphine milligram equivalents | Standard Deviation 14 |
| Interscalene Nerve Block | Opioid Medication Consumption in Morphine Milligram Equivalents | Intraoperative | 21 morphine milligram equivalents | Standard Deviation 11 |
| Interscalene Nerve Block | Opioid Medication Consumption in Morphine Milligram Equivalents | Postoperative day 1 | 18 morphine milligram equivalents | Standard Deviation 12 |
| Interscalene Nerve Block | Opioid Medication Consumption in Morphine Milligram Equivalents | Postoperative day 2 | 9 morphine milligram equivalents | Standard Deviation 10 |
| Interscalene Nerve Block | Opioid Medication Consumption in Morphine Milligram Equivalents | Postoperative day 3 | 3 morphine milligram equivalents | Standard Deviation 6 |
| Interscalene Nerve Block | Opioid Medication Consumption in Morphine Milligram Equivalents | Postoperative day 4 | 2 morphine milligram equivalents | Standard Deviation 6 |
| Liposomal Bupivacaine | Opioid Medication Consumption in Morphine Milligram Equivalents | Postoperative day 3 | 4 morphine milligram equivalents | Standard Deviation 8 |
| Liposomal Bupivacaine | Opioid Medication Consumption in Morphine Milligram Equivalents | Total Intraoperative + Postoperative day 1 | 60 morphine milligram equivalents | Standard Deviation 51 |
| Liposomal Bupivacaine | Opioid Medication Consumption in Morphine Milligram Equivalents | Postoperative day 2 | 7 morphine milligram equivalents | Standard Deviation 8 |
| Liposomal Bupivacaine | Opioid Medication Consumption in Morphine Milligram Equivalents | Intraoperative | 25 morphine milligram equivalents | Standard Deviation 14 |
| Liposomal Bupivacaine | Opioid Medication Consumption in Morphine Milligram Equivalents | Postoperative day 4 | 2 morphine milligram equivalents | Standard Deviation 5 |
| Liposomal Bupivacaine | Opioid Medication Consumption in Morphine Milligram Equivalents | Postoperative day 1 | 36 morphine milligram equivalents | Standard Deviation 48 |
Secondary
Patient Satisfaction With Pain Management
Visual Analog Scale (VAS) score for satisfaction with pain control in the hospital and at home. This was assessed at subjects' first postoperative visit.VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).
Time frame: At first postoperative visit, up to 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interscalene Nerve Block | Patient Satisfaction With Pain Management | Satisfaction with pain management in the hospital | 8.4 score on a scale | Standard Deviation 2.6 |
| Interscalene Nerve Block | Patient Satisfaction With Pain Management | Satisfaction with pain management at home | 8.7 score on a scale | Standard Deviation 1.9 |
| Liposomal Bupivacaine | Patient Satisfaction With Pain Management | Satisfaction with pain management in the hospital | 7.8 score on a scale | Standard Deviation 3.1 |
| Liposomal Bupivacaine | Patient Satisfaction With Pain Management | Satisfaction with pain management at home | 8.1 score on a scale | Standard Deviation 2.7 |
Secondary
Postoperative Visual Analog Scale (VAS) Pain Scores
We analyzed postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 hours and at the first postoperative visit. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).
Time frame: Up to first postoperative visit, maximum 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 6 hours postoperative | 2.9 score on a scale | Standard Deviation 3.1 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 12 hours postoperative | 4.0 score on a scale | Standard Deviation 3.1 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 18 hours postoperative | 5.2 score on a scale | Standard Deviation 3.4 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 30 hours postoperative | 4.8 score on a scale | Standard Deviation 2.9 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 36 hours postoperative | 4.1 score on a scale | Standard Deviation 2.9 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 42 hours postoperative | 4.0 score on a scale | Standard Deviation 2.8 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 48 hours postoperative | 4.2 score on a scale | Standard Deviation 2.8 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 54 hours postoperative | 4.2 score on a scale | Standard Deviation 2.7 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 60 hours postoperative | 4.1 score on a scale | Standard Deviation 2.6 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 66 hours postoperative | 3.8 score on a scale | Standard Deviation 2.6 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 72 hours postoperative | 3.8 score on a scale | Standard Deviation 2.6 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 78 hours postoperative | 4.0 score on a scale | Standard Deviation 2.4 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 84 hours postoperative | 4.0 score on a scale | Standard Deviation 2.7 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 90 hours postoperative | 3.9 score on a scale | Standard Deviation 2.5 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 96 hours postoperative | 3.8 score on a scale | Standard Deviation 2.4 |
| Interscalene Nerve Block | Postoperative Visual Analog Scale (VAS) Pain Scores | 1st postoperative visit | 3.4 score on a scale | Standard Deviation 2.6 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 1st postoperative visit | 4.4 score on a scale | Standard Deviation 2.5 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 6 hours postoperative | 5.1 score on a scale | Standard Deviation 2.9 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 60 hours postoperative | 3.9 score on a scale | Standard Deviation 2.1 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 12 hours postoperative | 4.6 score on a scale | Standard Deviation 3 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 84 hours postoperative | 4.1 score on a scale | Standard Deviation 2.6 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 18 hours postoperative | 4.6 score on a scale | Standard Deviation 3.1 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 66 hours postoperative | 3.6 score on a scale | Standard Deviation 2.2 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 30 hours postoperative | 4.6 score on a scale | Standard Deviation 2.7 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 96 hours postoperative | 4.3 score on a scale | Standard Deviation 2.8 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 36 hours postoperative | 5.1 score on a scale | Standard Deviation 2.2 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 72 hours postoperative | 3.7 score on a scale | Standard Deviation 2.6 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 42 hours postoperative | 4.6 score on a scale | Standard Deviation 2.8 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 90 hours postoperative | 4.1 score on a scale | Standard Deviation 2.5 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 48 hours postoperative | 4.3 score on a scale | Standard Deviation 2.7 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 78 hours postoperative | 4.2 score on a scale | Standard Deviation 2.6 |
| Liposomal Bupivacaine | Postoperative Visual Analog Scale (VAS) Pain Scores | 54 hours postoperative | 4.4 score on a scale | Standard Deviation 2.5 |