Liposome Bupivacaine for WRIST Blocks

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

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.

Study Overview

• Status: Completed
• Conditions: Dupuytren's Contracture of the Hand (Viking's Disease)
• Intervention / Treatment: Drug: Liposome bupivacaine + bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, B-3600
    • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in current pain over the first postoperative week	Pain rating (NRS) at rest and with movement	From baseline (before nerve block) through first postoperative week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in worst pain over the first postoperative week	Modified BRIEF Pain Inventory (Q1)	From discharge from hospital through first postoperative week
Change in ability to use hand	Hold Styrofoam cup	From discharge from hospital through first postoperative week
Change in sleep quality	Duration (h), quality rating (0 - 10)	From discharge from hospital through first postoperative week
Change in satisfaction with pain control	With pain control (0 - 10)	From discharge from hospital through first postoperative week
Change in sensory response in skin dermatomes	Cold, pinprick, light touch in the medial and ulnar nerve dermatomes	From beginning of nerve block through first postoperative week
Change in motor response in thumb and fingers	Abduction/adduction thumb/fingers	From beginning of nerve block through first postoperative week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of participants with side effects to regional anesthesia peripheral nerve blockade	Nausea, vomiting, fever, constipation, severe itching of the skin, dizziness, sleepless nights, excessive sweating, urinary retention, headache, heart palpitations	From beginning of nerve block through first postoperative week
Participants with adverse events	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	From date of signing ICF through the first postoperative week

Collaborators and Investigators

• Sponsor: Catherine Vandepitte, M.D.
• Collaborators: Pacira Pharmaceuticals, Inc
• Investigators: Study Director: Admir Hadzic, MD, PhD, Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start: January 2, 2017
• Primary Completion (ACTUAL): June 28, 2017
• Study Completion (ACTUAL): October 31, 2017

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 1601 (University Hospital Bern)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No