Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRebel Medicine Inc
About this trial
This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as a single-dose sciatic nerve block in the popliteal fossa in adult subjects undergoing primary unilateral bunionectomy. Approximately 60 subjects will be enrolled across 3 sequential dose cohorts (100 mg, 150 mg, 200 mg ALX006), with each cohort comparing ALX006 against MARCAINE 0.25% (bupivacaine HCl 50 mg) as the active comparator at a 3:1 randomization ratio. Dose escalation between cohorts is governed by an Independent Data Monitoring Committee.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, ages 18 or older at screening
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 5)
Able to provide informed consent, adhere to the study schedule, and complete all study assessments
Primary surgical indication is related to a bunion deformity (i.e., hallux valgus) and subject is scheduled to undergo a primary unilateral distal metaphyseal osteotomy procedure (i.e., Austin procedure)
Disqualifiers
Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the surgery and which, in the Investigator's opinion, may confound the post dosing assessments
Inadequate sensory function of the foot/ankle as assessed by the Investigator
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two (2) years
Trial design
Design model
Sequential
Treatments tested in this trial
ALX006 (bupivacaine extended-release injection)
DrugALX006 (50 mg/mL bupivacaine free base)
Bupivacaine Hcl 0.25% Inj
DrugBupivacaine HCl 0.25% plain (2.5 mg/mL)
Sciatic Nerve Block
Procedure/SurgerySciatic nerve block in the popliteal fossa
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: ALX006 100 mgExperimental treatment 2 interventions
Group B: ALX006 150 mgExperimental treatment 2 interventions
Group C: ALX006 200 mgExperimental treatment 2 interventions
Group D: MARCAINE 0.25%Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events (TEAEs)
TEAEs graded by CTCAE v5.0, summarized by System Organ Class and Preferred Term
Time frame
From start of nerve block procedure through 360 Hour Visit (Day 15)Secondary outcomes
1
AUC of NRS pain intensity scores 0-72 hours post-surgery
Area under the curve of 11-point Numeric Rating Scale (0 = no pain; 10 = worst possible pain) for current pain in operative foot
Time frame
0 to 72 hours post-surgery2
AUC of NRS pain intensity scores 0-96 hours post-surgery
Area under the curve of 11-point Numeric Rating Scale (0 = no pain; 10 = worst possible pain) for current pain in operative foot
Time frame
0 to 96 hours post-surgery3
AUC of NRS pain intensity scores 0-120 hours post-surgery
Area under the curve of 11-point Numeric Rating Scale (0 = no pain; 10 = worst possible pain) for current pain in operative foot
Time frame
0 to 120 hours post-surgery4
Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 72 hours post-surgery
Cumulative opioid consumption from the end of surgery through 72 hours, calculated as oral morphine equivalent dose (OMED) using CDC opioid morphine equivalent conversion factors.
Time frame
0 to 72 hours post-surgeryOther outcomes
1
Median time to onset of sensory block
Median time from end of block administration to the earliest timepoint with loss of light touch sensation along the distribution of the target nerve distal to the block site
Time frame
From end of block administration through 168 hours2
Median duration of sensory block
Median time between onset and offset of sensory block, where offset is defined as the first timepoint of return of light touch sensation in both test areas in a single assessment.
Time frame
From end of block administration through 168 hours3
Median time to onset of motor block
Median time from end of block administration to the earliest timepoint with partial or no foot movement
Time frame
From end of block administration through 168 hours4
Median duration of motor block
Median time between onset and offset of motor block, where offset is defined as resolution of motor block with complete foot movement (dorsiflexion and plantar flexion)
Time frame
From end of block administration through 168 hoursSponsors and contacts
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Source ClinicalTrials.gov