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Liposome Bupivacaine for ANKLE Blocks

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03106545
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : September 28, 2017
Information provided by (Responsible Party):
Admir Hadzic, M.D., Ph.D., New York School of Regional Anesthesia

Brief Summary:
Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid consumption as compared to bupivacaine alone or to general anesthesia.

Condition or disease Intervention/treatment Phase
Hallux Valgus (Bunions) Drug: Liposome bupivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Specific Blocks of the Distal Tibial and Deep Peroneal Nerves at the Level of the Ankle With a Mixture of Bupivacaine + Liposome Bupivacaine v Bupivacaine Alone v General Anesthesia
Actual Study Start Date : January 2, 2017
Actual Primary Completion Date : June 26, 2017
Estimated Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single mixture LB & bupivacaine
A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the distal tibial and deep peroneal nerves
Drug: Liposome bupivacaine
Active Comparator: Bupivacaine alone
Bupivacaine 0.5% (7.5 mL) injected into the distal tibial and deep peroneal nerves
Drug: Liposome bupivacaine
Sham Comparator: General anesthesia
General anesthesia
Drug: Liposome bupivacaine

Primary Outcome Measures :
  1. Change in current pain over the first postoperative week [ Time Frame: From baseline (before nerve block) through first postoperative week ]
    Pain rating (NRS) at rest and with movement

  2. Change in worst pain over the first postoperative week [ Time Frame: From discharge from PACU through first postoperative week ]
    Modified BRIEF Pain Inventory (Q1)

Secondary Outcome Measures :
  1. Change in ability to use foot [ Time Frame: From discharge from PACU through first postoperative week ]
    Stand with equal weight on both feet, wiggle toes, walk 10 steps

  2. Change in sleep quality [ Time Frame: From discharge from PACU through first postoperative week ]
    Duration (h), quality rating (0 - 10)

  3. Change in satisfaction with pain control [ Time Frame: From discharge from PACU through first postoperative week ]
    With pain control (0 - 10)

  4. Change in sensory response in skin dermatomes [ Time Frame: From premedication through first postoperative week ]
    Cold, pinprick, light touch in the distal tibial and deep peroneal nerve dermatomes

  5. Change in motor response in foot [ Time Frame: From premedication through first postoperative week ]
    Plantar flexion, dorsiflexion

Other Outcome Measures:
  1. Total number of participants with side effects to regional anesthesia peripheral nerve blockade [ Time Frame: From beginning of nerve block through first postoperative week ]
    Nausea, vomiting, fever, constipation, severe itching of the skin, dizziness, sleepless nights, excessive sweating, urinary retention, headache, heart palpitations

  2. Participants with adverse events [ Time Frame: From date of signing ICF through first postoperative week ]
    Any untoward medical occurrence (unfavorable and/or unintended change in a body structure or body function) associated with the use of a drug in humans, whether or not considered drug related

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, at least 18 years and max 65 years of age at screening
  • Scheduled to undergo primary Scarf osteotomy for elective hallux valgus
  • American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
  • Female subject must be surgically sterile or have a monogamous partner who is surgically sterile; or be at least 2 years postmenopausal; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study
  • Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch
  • Able to understand the English or Dutch language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
  • Able to adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

  • Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration
  • Planned concurrent surgical procedure (e.g., bilateral hallux valgus repair)
  • Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to hallux valgus and which may confound the postsurgical assessments (e.g., significant pain from other joints including chronic neuropathic pain, concurrent or prior contralateral knee or foot surgery)
  • Previous hallux valgus on the foot being considered for surgery
  • History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
  • Contraindication to bupivacaine, oxycodone, morphine, or hydromorphone
  • Chronic daily use of long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 24 hours
  • Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration.
  • Current use of systemic glucocorticosteroids within 1 month of study enrollment
  • Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration
  • History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in the extremities
  • Impaired kidney function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L] or blood urea nitrogen level >50 mg/dL [17.9 mmol/L]) or impaired liver function (e.g., serum aspartate aminotransferase [AST] level >3 times the upper limit of normal (ULN) or serum alanine aminotransferase [ALT] level >3 times the ULN
  • Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
  • Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity
  • Any chronic condition or disease that would compromise neurological or vascular assessments
  • Suspected or known history of drug or alcohol abuse within the previous year
  • Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
  • Previous participation in an EXPAREL study
  • Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study

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 identifier (NCT number): NCT03106545

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Contact: Maxine M Kuroda, PhD, MPH +1 (212) 665-1400

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Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, B-3600
Contact: Admir Hadzic, MD, PhD    +1 (212) 665-1400   
Sponsors and Collaborators
Admir Hadzic, M.D., Ph.D.

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Responsible Party: Admir Hadzic, M.D., Ph.D., Director, New York School of Regional Anesthesia Identifier: NCT03106545     History of Changes
Other Study ID Numbers: 1602
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
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

Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents