An interventional study of Liposomal bupivacaine and Interscalene Nerve Block in Osteoarthritis, Arthropathy and Shoulder Pain, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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).
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 108 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Interscalene Nerve Block
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Drug: Liposomal bupivacaine
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Also known as: Exparel
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.
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
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
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
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
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
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
| Milestone | Interscalene Nerve Block | Liposomal Bupivacaine |
|---|---|---|
| Started | 54 | 54 |
| Completed | 54 | 54 |
| Not completed | 0 | 0 |
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).
| score on a scale | Interscalene Nerve Block | Liposomal Bupivacaine |
|---|---|---|
| Visual Analog Scale Pain Score at 24 Hours Postoperatively | 5.0 ± 3.0 | 4.9 ± 2.7 |
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.
| morphine milligram equivalents | Interscalene Nerve Block | Liposomal Bupivacaine |
|---|---|---|
| Total Intraoperative + Postoperative day 1 | 38 ± 14 | 60 ± 51 |
| Intraoperative | 21 ± 11 | 25 ± 14 |
| Postoperative day 1 | 18 ± 12 | 36 ± 48 |
| Postoperative day 2 | 9 ± 10 | 7 ± 8 |
| Postoperative day 3 | 3 ± 6 | 4 ± 8 |
| Postoperative day 4 | 2 ± 6 | 2 ± 5 |
Duration of stay in hospital (hours) after shoulder replacement surgery.
| hours | Interscalene Nerve Block | Liposomal Bupivacaine |
|---|---|---|
| Length of Hospital Stay | 39 ± 20 | 36 ± 14 |
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).
| score on a scale | Interscalene Nerve Block | Liposomal Bupivacaine |
|---|---|---|
| 6 hours postoperative | 2.9 ± 3.1 | 5.1 ± 2.9 |
| 12 hours postoperative | 4.0 ± 3.1 | 4.6 ± 3.0 |
| 18 hours postoperative | 5.2 ± 3.4 | 4.6 ± 3.1 |
| 30 hours postoperative | 4.8 ± 2.9 | 4.6 ± 2.7 |
| 36 hours postoperative | 4.1 ± 2.9 | 5.1 ± 2.2 |
| 42 hours postoperative | 4.0 ± 2.8 | 4.6 ± 2.8 |
| 48 hours postoperative | 4.2 ± 2.8 | 4.3 ± 2.7 |
| 54 hours postoperative | 4.2 ± 2.7 | 4.4 ± 2.5 |
| 60 hours postoperative | 4.1 ± 2.6 | 3.9 ± 2.1 |
| 66 hours postoperative | 3.8 ± 2.6 | 3.6 ± 2.2 |
| 72 hours postoperative | 3.8 ± 2.6 | 3.7 ± 2.6 |
| 78 hours postoperative | 4.0 ± 2.4 | 4.2 ± 2.6 |
| 84 hours postoperative | 4.0 ± 2.7 | 4.1 ± 2.6 |
| 90 hours postoperative | 3.9 ± 2.5 | 4.1 ± 2.5 |
| 96 hours postoperative | 3.8 ± 2.4 | 4.3 ± 2.8 |
| 1st postoperative visit | 3.4 ± 2.6 | 4.4 ± 2.5 |
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).
| score on a scale | Interscalene Nerve Block | Liposomal Bupivacaine |
|---|---|---|
| Satisfaction with pain management in the hospital | 8.4 ± 2.6 | 7.8 ± 3.1 |
| Satisfaction with pain management at home | 8.7 ± 1.9 | 8.1 ± 2.7 |
Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.
| minutes | Interscalene Nerve Block | Liposomal Bupivacaine |
|---|---|---|
| Length of Stay in the Post-anesthesia Care Unit (PACU) | 102 ± 53 | 139 ± 77 |
Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interscalene Nerve Block | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Liposomal Bupivacaine | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Age, Categorical(Participants) | Interscalene Nerve Block | Liposomal Bupivacaine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 24 | 41 |
| >=65 years | 37 | 30 | 67 |
| Age, Continuous(years) | Interscalene Nerve Block | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Mean | 68 ± 10 | 65 ± 9 | 67 ± 9 |
| Sex: Female, Male(Participants) | Interscalene Nerve Block | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Female | 24 | 23 | 47 |
| Male | 30 | 31 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Interscalene Nerve Block | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 2 | 7 |
| Not Hispanic or Latino | 49 | 52 | 101 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Interscalene Nerve Block | Liposomal Bupivacaine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 13 | 21 |
| White | 46 | 40 | 86 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Interscalene Nerve Block | Liposomal Bupivacaine | Total |
|---|---|---|---|
| United States | 54 | 54 | 108 |
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Studies of the drug tested here: Liposomal Bupivacaine