Randomized Controlled Trial for Exparel Hip Fracture

NCT03289858 | Completed Phase 4 Results FDA Drug

• 1 other identifier: H00013594
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Opiate Requirements

  Morphine meq given

  72 hours

Study Arms (2)

Exparel (Liposomal Bupivacaine)

EXPERIMENTAL

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 Control

PLACEBO COMPARATOR

Saline Solution (Sodium Chloride)

Drug: Sodium Chloride

Interventions

Exparel DRUG

Subcutaneous injection at conclusion of surgical fixation of hip fracture

Also known as: Liposomal Bupivacaine

Exparel (Liposomal Bupivacaine)

Sodium Chloride DRUG

Saline Injection

Also known as: Saline

Saline Control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 or older
• Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or hemiarthroplasty
• Able to consent
• Isolated injury

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Orthopaedic Trauma Association: collaborator
• University of Kentucky: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (32)

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  PMID: 19826027 BACKGROUND

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• Sanzone AG. Current Challenges in Pain Management in Hip Fracture Patients. J Orthop Trauma. 2016 May;30 Suppl 1:S1-5. doi: 10.1097/BOT.0000000000000562.

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• Berend ME, Berend KR, Lombardi AV Jr. Advances in pain management: game changers in knee arthroplasty. Bone Joint J. 2014 Nov;96-B(11 Supple A):7-9. doi: 10.1302/0301-620X.96B11.34514.

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• Ma J, Zhang W, Yao S. Liposomal bupivacaine infiltration versus femoral nerve block for pain control in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2016 Dec;36(Pt A):44-55. doi: 10.1016/j.ijsu.2016.10.007. Epub 2016 Oct 11.

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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. No abstract available.

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• 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.

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• Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.

  PMID: 25282071 BACKGROUND

• Zuckerman JD. Hip fracture. N Engl J Med. 1996 Jun 6;334(23):1519-25. doi: 10.1056/NEJM199606063342307. No abstract available.

  PMID: 8618608 BACKGROUND

• Menzies IB, Mendelson DA, Kates SL, Friedman SM. The impact of comorbidity on perioperative outcomes of hip fractures in a geriatric fracture model. Geriatr Orthop Surg Rehabil. 2012 Sep;3(3):129-34. doi: 10.1177/2151458512463392.

  PMID: 23569706 BACKGROUND

• 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.

  PMID: 25995494 BACKGROUND

• Marcantonio ER, Flacker JM, Wright RJ, Resnick NM. Reducing delirium after hip fracture: a randomized trial. J Am Geriatr Soc. 2001 May;49(5):516-22. doi: 10.1046/j.1532-5415.2001.49108.x.

  PMID: 11380742 BACKGROUND

• 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.

  PMID: 28640101 BACKGROUND

• 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.

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• McGraw-Tatum MA, Groover MT, George NE, Urse JS, Heh V. A Prospective, Randomized Trial Comparing Liposomal Bupivacaine vs Fascia Iliaca Compartment Block for Postoperative Pain Control in Total Hip Arthroplasty. J Arthroplasty. 2017 Jul;32(7):2181-2185. doi: 10.1016/j.arth.2017.02.019. Epub 2017 Feb 16.

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• 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.

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  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Eric Swart
• Organization: University of Massachusetts, Worcester

eric.swart@umassmemorial.org

503-880-7125

Study Officials

• Eric Swart, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

• Paul Matuszewski, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eric F. Swart, MD

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 21, 2017
• Study Start: September 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 22, 2019
• Last Updated: March 18, 2021
• Results First Posted: February 25, 2020

Record last verified: 2021-03

Locations

US (2)