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Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679560
Recruitment Status : Terminated (Poor recruitment)
First Posted : February 10, 2016
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ian Elliott Brown, University of California, Davis

Brief Summary:
This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.

Condition or disease Intervention/treatment Phase
Femoral Fractures Drug: Liposomal Bupivacaine Drug: Ropivacaine HCL Phase 2

Detailed Description:

In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will result in less total opioid administration during the randomization period compared to a fascia iliaca compartment block using 0.2% ropivacaine.

The long-term goal of this study is to provide pilot information to guide and design larger, multicenter trials which will evaluate the utility and cost-effectiveness of long acting liposomal bupivacaine as an opioid-sparring analgesic strategy in injured trauma patients. Ultimately, it is hoped that this information can improve safe and effective narcotic sparing analgesia in the awake, combat casualty, as well as serve as primary steps towards

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : November 1, 2019


Arm Intervention/treatment
Active Comparator: Liposomal Bupivacaine
In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered
Drug: Liposomal Bupivacaine
A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine
Other Name: Exparel®

Placebo Comparator: Ropivacaine HCL
In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered
Drug: Ropivacaine HCL
Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.
Other Name: Naropin (trade name)




Primary Outcome Measures :
  1. Opioid requirements [ Time Frame: Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale. ]
    Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents


Secondary Outcome Measures :
  1. Patient outcomes [ Time Frame: Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale. ]
    Total daily opioid requirements for days 1-3, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age ≥18 years ≤ 70 years
  2. Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital
  3. Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident.

Exclusion Criteria:

  1. >10 hours since presentation to the emergency department
  2. History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.
  3. Central or peripheral neurologic deficit on presentation
  4. Concern or compartment syndrome
  5. Associated additional long bone fractures
  6. End stage liver failure
  7. Renal failure requiring dialysis
  8. Pregnancy or breast feeding
  9. Prisoners
  10. Coagulopathy with INR >1.5
  11. Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)
  12. Suspected prolonged intubation within first 12 hours secondary to respiratory failure other than peri-procedurally
  13. Adults unable to consent
  14. Pediatric patients <18 years old
  15. Patients exhibiting signs of shock upon admission, HR >120 or SBP <100 mmHg.
  16. History of allergic reaction to local anesthetics
  17. Administration of any other local anesthetic in the 2 hours prior to the study enrollment.
  18. Distal femur fractures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679560


Locations
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United States, California
University of California Davis Med Center- Trauma and Acute Care Surgery
Sacramento, California, United States, 95817
Sponsors and Collaborators
Ian Elliott Brown
United States Department of Defense
Investigators
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Principal Investigator: Ian Brown, MD University of California, Davis
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Responsible Party: Ian Elliott Brown, Assistant Professor of Surgery, University of California, Davis
ClinicalTrials.gov Identifier: NCT02679560    
Other Study ID Numbers: 782382
D6.715L15J91110 ( Other Grant/Funding Number: Defense Health Program )
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ian Elliott Brown, University of California, Davis:
femur fracture, hip fracture, exparel, liposomal bupivacaine
Additional relevant MeSH terms:
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Acute Pain
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Pain
Neurologic Manifestations
Leg Injuries
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents