Introduction of collagenase clostridium histolyticum injection for the treatment of Dupuytren’s contractures. MedDRA version: 19.0 Level: PT Classification code 10013873 Term: Dupuytren's contracture operation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Exparel
Product Name: Exparel
Pharmaceutical Form: Injection
Trade Name: Marcaine (bupivacaine) 0.5%
Product Name: Marcaine 0,5%
Pharmaceutical Form: Injection
Sponsors
Ziekenhuis Oost Limburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female, at least 18 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; or at least 2 years postmenopausal or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Currently pregnant, nursing or planning to become pregnant during the study or within 1 moth after study drug administration • Planned concurrent surgical procedure • Previous Dupuytren’s contracture on the hand being considered for surgery • 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 to of peripheral nerves or to communicate with staff • 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 (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 • Malignancy in the last 2 years, with exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The introduction of collagenase clostridium histolyticum (commercialized as Xiapex® or Xiaflex®) injection has been an advance in the treatment of Dupuytren’s contractures. The treatment consists of two phases. In the first phase, the collagenase is injected into the Dupuytren’s cord. In a second phase, 24 to 48 hours later, manipulation of the injected fingers is planed. Passive finger extension ruptures the enzymatically weakened Dupuytren’s cord. The anesthetic challenges for this procedure are finding one anesthetic intervention for both injection of collagenase and manipulation of the cords are painful. With the upcoming availability of liposomal bupivacaine (Exparel®), we hypothesize that anesthesia and analgesia for both procedures can be accomplished with a single anesthetic intervention by blocking both median and ulnar nerve. ;Secondary Objective: * Numeric rating scale (NRS) * Overall Benefit of Analgesia Score (OBAS) (Lehmann, 2010) * Start and duration of the sensorial block with monitoring of the second phase of the sensorial block * Start and duration of the sensorial block with monitoring of the second phase of the sensorial block motor block * Duration of sleep and sleepquality during the week of intervention * Patient satisfaction concerning analgesia * Functionality of the operated limb * Patient satisfaction * Surgeon satisfaction;Primary end point(s): Anesthesia and analgesia for both phases of the treatment with Xiapex in patients with Dupuytren's contracture with a single periferal nerve block. ;Timepoint(s) of evaluation of this end point: Investigation will be done every 5 minutes once the block is preformed. Then at timepoint 1h and 1h30. Patients will be contacted after discharge at 24h, 36h, 48h, 60h, 72h, 84h, 96h, 5, 6 and 7 days and 6 weeks after the nerve block. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Numeric rating scale (NRS) * Overall Benefit of Analgesia Score (OBAS) (Lehmann, 2010) * Start and duration of the sensorial block with monitoring of the second phase of the sensorial block * Start and duration of the sensorial block with monitoring of the second phase of the sensorial block motor block * Duration of sleep and sleepquality during the week of intervention * Patient satisfaction concerning analgesia * Functionality of the operated limb * Patient satisfaction * Surgeon satisfaction;Timepoint(s) of evaluation of this end point: Investigation will be done every 5 minutes once the block is preformed. Then at timepoint 1h and 1h30. Patients will be contacted after discharge at 24h, 36h, 48h, 60h, 72h, 84h, 96h, 5, 6 and 7 days and 6 weeks after the nerve block. | — |
Countries
Belgium
Contacts
Public ContactIne Leunen
Ziekenhuis Oost Limburg
Outcome results
None listed