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Liposome Bupivacaine for WRIST Blocks

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ClinicalTrials.gov Identifier: NCT03106519
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Admir Hadzic, M.D., Ph.D., New York School of Regional Anesthesia

Brief Summary:
Treatment of Dupuytren's contracture requires multiple injections into the palm of the hand to weaken the cords, followed by rupture of the strands 2 days later. Anesthesia is required for both phases of treatment. It is hypothesized that extended-release liposome bupivacaine prolongs nerve blockade of the wrist allowing patients to undergo this 2-part regimen with less pain.

Condition or disease Intervention/treatment Phase
Dupuytren's Contracture of the Hand (Viking's Disease) Drug: Liposome bupivacaine + bupivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Distal Extremity (Wrist) Nerve Blocks With a Mixture of Liposome Bupivacaine + Bupivacaine Versus Bupivacaine Alone for Patients Having Dupuytren's Contracture Release: a Blinded Randomized Controlled Trial
Study Start Date : January 2, 2017
Actual Primary Completion Date : June 28, 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 median and ulnar nerves
Drug: Liposome bupivacaine + bupivacaine
Active Comparator: Bupivacaine alone
Bupivacaine 0.5% (7.5 mL) injected into the median and ulnar nerves
Drug: Liposome bupivacaine + 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


Secondary Outcome Measures :
  1. Change in worst pain over the first postoperative week [ Time Frame: From discharge from hospital through first postoperative week ]
    Modified BRIEF Pain Inventory (Q1)

  2. Change in ability to use hand [ Time Frame: From discharge from hospital through first postoperative week ]
    Hold Styrofoam cup

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

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

  5. Change in sensory response in skin dermatomes [ Time Frame: From beginning of nerve block through first postoperative week ]
    Cold, pinprick, light touch in the medial and ulnar nerve dermatomes

  6. Change in motor response in thumb and fingers [ Time Frame: From beginning of nerve block through first postoperative week ]
    Abduction/adduction thumb/fingers


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 the 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, at least 18 years and max 85 years of age at screening
  • Scheduled to undergo Dupuytren's contracture release
  • American Society of Anesthesiologists (ASA) physical status I, II or III
  • Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick and light touch
  • Female subjects must be surgically sterile or have a monogamous partner who is surgically sterile; 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 understand the English or Dutch language, purpose and risks of the study
  • Able to provide informed consent and authorization to use protected health information, 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 moth after study drug administration
  • History of hypersensitivity to local anesthetics
  • Contraindication to bupivacaine, paracetamol, ketorolac, oxycodone or morphine
  • Medical condition that will make it difficult to assess sensory distributions of peripheral nerves or to communicate with staff
  • Chronic scheduled use of any of the following medications within the times specified before surgery: long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours
  • Suspected or known recent history (< 3 months) of drug or alcohol abuse
  • Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Dupuytren's contracture and which may confound the postsurgical assessments
  • Infection at the planned block site
  • 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®)
  • Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration
  • Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
  • 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
  • Presence of preexisting coagulation disorders
  • Baseline neurological deficits
  • 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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03106519


Contacts
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Contact: Maxine M Kuroda, PhD, MPH +1 (212) 665-1400 maxkuroda2014@gmail.com

Locations
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Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, B-3600
Contact: Admir Hadzic, MD, PhD    +1 (212) 665-1400    admir@nysora.com   
Sponsors and Collaborators
Admir Hadzic, M.D., Ph.D.
Pacira Pharmaceuticals, Inc
Investigators
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Study Director: Admir Hadzic, MD, PhD Ziekenhuis Oost-Limburg

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Responsible Party: Admir Hadzic, M.D., Ph.D., Director, New York School of Regional Anesthesia
ClinicalTrials.gov Identifier: NCT03106519     History of Changes
Other Study ID Numbers: 1601
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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Dupuytren Contracture
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents