Liposome Bupivacaine for WRIST Blocks

NCT ID: NCT03106519

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-02
• Study Completion Date: 2017-10-31

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.

Conditions

Dupuytren's Contracture of the Hand (Viking's Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Liposome bupivacaine + bupivacaine

Intervention Type: DRUG

Bupivacaine alone

Bupivacaine 0.5% (7.5 mL) injected into the median and ulnar nerves

Group Type: ACTIVE_COMPARATOR

Liposome bupivacaine + bupivacaine

Intervention Type: DRUG

Interventions

Liposome bupivacaine + bupivacaine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Catherine Vandepitte, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Catherine Vandepitte, M.D.

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Admir Hadzic, MD, PhD

Role: STUDY_DIRECTOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Countries

Belgium

Other Identifiers

1601

Identifier Type: -

Identifier Source: org_study_id