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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interscalene Nerve Block | Active Comparator | 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. |
|
| Liposomal Bupivacaine | Experimental | Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uma Srikumaran, MD, MBA | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Columbia | Maryland | 21044 | United States | ||
| University of Texas Southwestern Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Liposomal Bupivacaine | Patients in this group will receive a periarticular injection containing liposomal bupivacaine and with local bupivacaine during surgery. The injection will be administered by the surgeon. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | At 24 hours after surgery |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Uma Srikumaran | Johns Hopkins University | 443-546-1550 | us@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2016 | Mar 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D018771 | Arthralgia |
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|
| Interscalene Nerve Block | Drug | 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. |
|
| Length of Hospital Stay |
Duration of stay in hospital (hours) after shoulder replacement surgery. |
| At the time of discharge from hospital, Up to 4 days |
| 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). | Up to first postoperative visit, maximum 30 days |
| 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). | At first postoperative visit, up to 30 days |
| Length of Stay in the Post-anesthesia Care Unit (PACU) | Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery. | At the time of discharge from PACU, Up to 1 day |
| Dallas |
| Texas |
| 75390 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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. |
|
|
| 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. | Posted | Mean | Standard Deviation | morphine milligram equivalents | Up to 4 days postoperatively |
|
|
|
| Secondary | Length of Hospital Stay | Duration of stay in hospital (hours) after shoulder replacement surgery. | Posted | Mean | Standard Deviation | hours | At the time of discharge from hospital, Up to 4 days |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Up to first postoperative visit, maximum 30 days |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | At first postoperative visit, up to 30 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | At the time of discharge from PACU, Up to 1 day |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | 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. | 0 | 54 | 0 | 54 | 0 | 54 |
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| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Postoperative day 1 |
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| Postoperative day 2 |
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| Postoperative day 3 |
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| Postoperative day 4 |
|
| 18 hours postoperative |
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| 30 hours postoperative |
|
| 36 hours postoperative |
|
| 42 hours postoperative |
|
| 48 hours postoperative |
|
| 54 hours postoperative |
|
| 60 hours postoperative |
|
| 66 hours postoperative |
|
| 72 hours postoperative |
|
| 78 hours postoperative |
|
| 84 hours postoperative |
|
| 90 hours postoperative |
|
| 96 hours postoperative |
|
| 1st postoperative visit |
|