Recent Updates
Recently added Catalysts

ISB

Phase 1

Postoperative Pain | Unknown | Pain |Baxter International Inc.|Last Updated: Jun 4, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01881776Continuous Interscalene Block Results in Superior Recovery Throughout the First Postoperative WeekEARLY_PHASE1 COMPLETED 71Aug 1, 2011Jun 1, 2012Jun 4, 20141 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4
throughout the first postoperative week on days 1, 2, 3, and 7

The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)

Secondary Endpoints
Time-to-first Pain
throughout the first postoperative week
The Number of Patients Consume ≥1 Dose of Analgesics
throughout the first postoperative week
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Single ISB (SISB) groupACTIVE_COMPARATORPatients in this group received single injection (SISB) interscalene brachial plexus block
Continuous ISB (CISB) groupACTIVE_COMPARATORPatients in this group received continuous (CISB) interscalene brachial plexus block
General anesthesia (GA) groupNO_INTERVENTIONPatients in this group received general anesthesia (GA)
Interventions
NameTypeDescription
ISBPROCEDUREIn SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III patients ≥ 18 years of age BMI ≤ 35 kg/m2 Scheduled for elective arthroscopic shoulder surgery Exclusion Criteria: Patients who were undertaken open shoulder procedures Patients with difficulty understanding th...

Countries:United States
Unlock Eligibility Criteria