A Phase 4 interventional study of Exparel and Sodium Chloride in Hip Fractures, sponsored by University of Massachusetts, Worcester. Completed at 2 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by University of Massachusetts, Worcester · Phase 4, Interventional, and Treatment
This is a prospective, randomized study looking at the effect that a long-acting local anesthetic has on pain control in patients having surgery for hip fractures. The investigators are conducting the study to see if that reduces the amount of pain medicine needed after surgery, and if it reduces other medical complications after surgery.
Osteoporotic fragility fractures of the hip are common in the geriatric population, are increasing in frequency, and represent a growing social and economic burden. Pain control after surgical treatment is an area of growing interest, as improvement in post-injury pain is often an important indication for surgical treatment of hip fractures.
Typically a mainstay of post-operative pain control, the use of opiates has come under increasing scrutiny, as it has been shown to be associated with delirium, respiratory depression, and even may even lead to addiction or abuse in the medically frail geriatric population. These concerns have led to efforts to minimize the use of post-operative opiates in hip fracture patients. In that context, a treatment that could reduce the necessity of post-op narcotics while still improving pain control would be potentially valuable.
There has been growing interest in the use of long-acting local anesthetics for improving pain control in orthopaedics, particularly in the elective total joint arthroplasty population. Studies have shown that arthroplasty patients receiving long-acting local anesthetics have decreased opiate requirements, reduced length of stay, and lower costs. Although well-demonstrated in the elective arthroplasty population, the effects of long-acting local anesthetics have yet to be demonstrated in the hip fracture population. Given that these fractures frequently occur in medically frail patients with multiple comorbidities, in whom post-operative confusion and delirium are relatively common, there is the potential for treatments that decrease opiate requirements to demonstrate substantial medical and economic benefits.
Exparel (liposomal bupivacaine) and long-acting local anesthetics have been used extensively in hip replacement surgery and have not been shown to be associated with any increased risks. In the case of patients with displaced femoral neck fractures treated with arthroplasty, the surgical techniques are identical to those being used in this study. Exparel has also been used in trauma surgery as well as foot and ankle surgery without any increased described risks, although its use explicitly in hip fractures has not been published. However, the PI has trained in other medical centers where Exparel is routinely used in hip fracture patients without any identified increased risks or complications, but there is a paucity of data on this subject, which is the rationale for this study.
The investigators hypothesize that in patients with osteoporotic fragility fractures of the hip, patients receiving intraoperative long-acting local anesthetics will have decreased pain and decreased post-operative opiate requirements, leading to less delirium and decreased hospital resource utilization during their index hospitalization.
The goal is to conduct a multi-center prospective randomized control trial to determine if liposomal bupivacaine is superior to standard of care by addressing the below separate but related aims:
842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.
This study's enrollment of 55 is below the median of 86 across 533 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
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Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia."
Drug: Exparel
Saline Solution (Sodium Chloride)
Drug: Sodium Chloride
Subcutaneous injection at conclusion of surgical fixation of hip fracture
Also known as: Liposomal Bupivacaine
Saline Injection
Also known as: Saline
Opiate Requirements
Morphine meq given
Time frame: 72 hours
| Milestone | Exparel (Liposomal Bupivacaine) | Saline Control |
|---|---|---|
| Started | 27 | 28 |
| Completed | 25 | 28 |
| Not completed | 2 | 0 |
Morphine meq given
| Morphine mEq | Exparel (Liposomal Bupivacaine) | Saline Control |
|---|---|---|
| Opiate Requirements | 52.5 (30.21 to 74.75) | 65.39 (45.68 to 85.10) |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exparel (Liposomal Bupivacaine) | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Saline Control | 0/28 (0%) | 1/28 (3.6%) | 0/28 (0%) |
| Event | Exparel (Liposomal Bupivacaine) | Saline Control |
|---|---|---|
| InfectionSkin and subcutaneous tissue disorders | 0/27 | 1/28 |
| Age, Continuous(years) | Exparel (Liposomal Bupivacaine) | Saline Control | Total |
|---|---|---|---|
| Mean | 76 ± 8.6 | 77 ± 9.2 | 76 ± 8.8 |
| Sex: Female, Male(Participants) | Exparel (Liposomal Bupivacaine) | Saline Control | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 7 | 8 | 15 |
| Race and Ethnicity Not Collected(Participants) | Exparel (Liposomal Bupivacaine) | Saline Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Exparel (Liposomal Bupivacaine) | Saline Control | Total |
|---|---|---|---|
| United States | 27 | 28 | 55 |
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine
University of Massachusetts, Worcester →