Randomized Controlled Trial for Exparel Hip Fracture

Hip Fractures Clinical Trial

Official title:

Does the Use of Liposomal Bupivacaine Decrease Narcotic Requirements in Geriatric Hip Fractures? A Randomized, Double Blinded Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289858
• Other study ID #: H00013594
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: January 22, 2019

Study information

• Verified date: March 2021
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. Determine the effectiveness of Exparel to reduce narcotic requirements and pain post operatively after hip fracture treatment. Excess narcotic use in the elderly population is associated with a host of complications often magnified by polypharmacy, including in hospital delirium, increased length of stay, nausea, constipation, urinary retention, respiratory depression and others. Decreasing narcotic usage in this group of patients following hip fracture can possibly reduce such complications. Patients will receive standard of care medical treatment and be randomized to intra-operative Exparel vs. placebo injections. Opioid requirements, complications, pain score, and length of stay will be assessed in the post-operative period. Hypothesis: The investigators hypothesize that total morphine requirements and pain scores will be decreased in this group following the administration of exparel in the geriatric hip fracture fracture population.

2. Determine the effectiveness of Exparel to reduce delirium in post-operative hip fracture patients. In hospital delirium in elderly patients is associated with poor outcomes, including prolonged length of stay, poor participation in rehabilitation, and falls. Use of a locally administered liposomal bupivacaine could decrease the need for additional medications for pain control in addition to decreased mental stress for patients in this unfamiliar situation, thus resulting in decreased episodes of delirium. The investigators will assess delirium utilizing Confusion Assessment Method (CAM) scores in the post-operative period at regularly scheduled intervals and compare average scores between the treatment / standard of care group. Hypothesis: The investigators hypothesize that total episodes of delirium will be decreased in the liposomal bupivacaine group.

3. Determine if Exparel is cost-effective in hip fracture patients. The costs associated with increased narcotic usage, prolonged stay, resources, and complications can be significant. The use of liposomal bupivacaine may lead to decreased resource utilization to care for hip fractures. The investigators will conduct an economic analysis evaluating total inpatient hospitalization costs including costs associated with length of stay, medication requirements, and resources associated with consultations and diagnostic evaluations. These costs will be compared against the cost of Exparel administration to evaluate the net cost effect of the intervention. Hypothesis: The investigators hypothesize that the net cost of inpatient care will be decreased when compared to standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 22, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Age 55 or older

• Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or hemiarthroplasty

• Able to consent

• Isolated injury

Exclusion Criteria:

• OTA/AO 31B1 (Impacted/slightly displaced)

• Baseline dementia or cognitive deficit

• Inability to consent

• Chronic Opioid use

• End stage liver disease with Model for End-Stage Liver Disease (MELD) greater than 20.

• End stage renal disease as defined by patients requiring hemodialysis at least twice weekly

• Polytrauma, defined as: concurrent upper or lower extremity fracture, pelvis fracture, spine fracture, rib fractures, or facial fractures, Blunt chest or abdominal trauma resulting in diagnosed organ injury, Head trauma resulting in intracranial bleed or diagnosed concussion

• Allergy to amide-type local anesthetics

• Prisoners (unlikely to be accessible for follow-up)

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• Exparel
Subcutaneous injection at conclusion of surgical fixation of hip fracture
• Sodium Chloride
Saline Injection

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Orthopaedic Trauma Association, University of Kentucky

Country where clinical trial is conducted

United States, 

References & Publications (31)

Asche CV, Ren J, Kim M, Gordon K, McWhirter M, Kirkness CS, Maurer BT. Local infiltration for postsurgical analgesia following total hip arthroplasty: a comparison of liposomal bupivacaine to traditional bupivacaine. Curr Med Res Opin. 2017 Jul;33(7):1283-1290. doi: 10.1080/03007995.2017.1314262. Epub 2017 Apr 28. — View Citation

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Cherian JJ, Muzaffar A, Barrington JW, Elmallah RD, Chughtai M, Mistry JB, Mont MA. Liposomal Bupivacaine in Total Knee Arthroplasty for Better Postoperative Analgesic Outcome and Economic Benefits. J Knee Surg. 2016 Jul;29(5):e2. doi: 10.1055/s-0036-1584270. Epub 2016 Jun 10. — View Citation

Chughtai M, Cherian JJ, Mistry JB, Elmallah RD, Bennett A, Mont MA. Liposomal Bupivacaine Suspension Can Reduce Lengths of Stay and Improve Discharge Status of Patients Undergoing Total Knee Arthroplasty. J Knee Surg. 2016 Apr;29(3):224-7. doi: 10.1055/s-0036-1571431. Epub 2016 Feb 2. — View Citation

Domb BG, Gupta A, Hammarstedt JE, Stake CE, Sharp K, Redmond JM. The effect of liposomal bupivacaine injection during total hip arthroplasty: a controlled cohort study. BMC Musculoskelet Disord. 2014 Sep 24;15:310. doi: 10.1186/1471-2474-15-310. — View Citation

Herbst SA. Local infiltration of liposome bupivacaine in foot and ankle surgery: case-based reviews. Am J Orthop (Belle Mead NJ). 2014 Oct;43(10 Suppl):S10-2. Review. — View Citation

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Ma TT, Wang YH, Jiang YF, Peng CB, Yan C, Liu ZG, Xu WX. Liposomal bupivacaine versus traditional bupivacaine for pain control after total hip arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(25):e7190. doi: 10.1097/MD.0000000000007190. Review. — View Citation

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Morrison RS, Dickman E, Hwang U, Akhtar S, Ferguson T, Huang J, Jeng CL, Nelson BP, Rosenblatt MA, Silverstein JH, Strayer RJ, Torrillo TM, Todd KH. Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial. J Am Geriatr Soc. 2016 Dec;64(12):2433-2439. doi: 10.1111/jgs.14386. Epub 2016 Oct 27. — View Citation

Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW. Multimodal periarticular injection vs continuous femoral nerve block after total knee arthroplasty: a prospective, crossover, randomized clinical trial. J Arthroplasty. 2012 Jun;27(6):1234-8. doi: 10.1016/j.arth.2011.12.021. Epub 2012 Feb 8. — View Citation

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Wei LA, Fearing MA, Sternberg EJ, Inouye SK. The Confusion Assessment Method: a systematic review of current usage. J Am Geriatr Soc. 2008 May;56(5):823-30. doi: 10.1111/j.1532-5415.2008.01674.x. Epub 2008 Apr 1. Review. — View Citation

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Yu SW, Szulc AL, Walton SL, Davidovitch RI, Bosco JA, Iorio R. Liposomal Bupivacaine as an Adjunct to Postoperative Pain Control in Total Hip Arthroplasty. J Arthroplasty. 2016 Jul;31(7):1510-5. doi: 10.1016/j.arth.2016.01.004. Epub 2016 Jan 21. — View Citation

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Zywiel MG, Hurley RT, Perruccio AV, Hancock-Howard RL, Coyte PC, Rampersaud YR. Health economic implications of perioperative delirium in older patients after surgery for a fragility hip fracture. J Bone Joint Surg Am. 2015 May 20;97(10):829-36. doi: 10.2106/JBJS.N.00724. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate Requirements	Morphine meq given	72 hours