Pterygopalatine Fossa (PPF) Block as an Opioid Sparing Treatment for Acute Headache in Spontaneous Subarachnoid Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 17
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial with a sequential parallel comparison design (SPCD) of bilateral pterygopalatine fossa (PPF) injections with 20mg ropivacaine + 4mg dexamethasone (active, PPF-block) compared to saline (placebo) for headache in survivors of aneurysmal subarachnoid hemorrhage (SAH), while monitoring intracranial arterial mean flow velocities with transcranial Doppler (TCD) peri-intervention (intervention = PPF-injections: active or placebo)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated ICF by participant or a legally authorized representative (LAR)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged ≥18 and ≤ 85 years
- •Admitted with a primary diagnosis of spontaneous, non-traumatic, SAH within 72 hours of ictus hemorrhage
- •Disease-specific inclusion criteria:
- •Spontaneous, non-traumatic SAH
- •Subarachnoid pattern of hemorrhage warranting diagnostic DSA due to involvement of at least one of the following regions: quadrigeminal plate, prepontine cistern, perimesencephalic cistern, Sylvian fissure, or surrounding Circle of Willis
- •Modified Fisher grade 1-4 (on presentation imaging)
- •Hunt and Hess 1-3 or World Federation of Neurosurgeons grade 1-4 (on screening, included only if also fulfilling Glasgow Coma Scale verbal subscore ≥4)
- •Minimum Glasgow Coma Scale verbal subscore of 4 (on screening)
- •Able to verbalize pain scale scores according to 11-point numeric pain scale
- •In order to be enrolled and undergo randomization in this study, an individual must meet all of the additional criteria:
- •Stabilization period criteria:
- •A minimum of 4 hours from DSA with clipping or coiling procedure (whenever applicable)
- •Successful treatment of culprit vascular lesion (i.e., ≥90% obliteration of aneurysm), when applicable
- •Requiring a minimum of 15mg OME prn for headache analgesia during any 24-hour period during eligibility period
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Premorbid conditions:
- •Pre-existing neurologic, psychiatric, or other condition that would confound neurologic assessment or would make difficult/impossible to accurately assess neurologic and/or functional outcome
- •Pre-existing diffuse flow-limiting narrowing of arteries in the Circle of Willis, regardless of etiology (e.g., atherosclerosis, vasculitis, Moya-Moya syndrome)
- •Prior use of opioid or barbiturate analgesics for at least two-thirds of the days in previous month, regardless of indication
- •Diagnosis of substance use disorder in the previous year
- •Infected or wounded skin, or a skin lesion at the site of puncture for PPF- injection
- •Uncorrected coagulopathy
- •Platelet count < 50,000/μL, International Normalized Ratio (INR) > 1.7
- •Requiring use of systemic anticoagulation and antiplatelet therapy (except for aspirin monotherapy).
- •SAH-specific:
- •Head trauma as etiology of SAH
- •Infection as cause for aneurysm or SAH (i.e., mycotic aneurysms)
- •Inability to successfully treat culprit vascular lesion
- •Diffuse vasospasm on pre-enrollment diagnostic CTA or DSA. Vasospasm is defined as moderate-to-severe arterial narrowing on DSA or CTA not attributable to atherosclerosis, catheter-induced spasm, or vessel hypoplasia, as determined by a neuroradiologist or neurointerventionalist
- •Standard pain regimen conditions
- •Elevation of hepatic enzymes prohibiting use of scheduled APAP (i.e., AST or ALT > 3x upper limit level)
- •Chronic liver condition with absolute contra-indication for APAP (even at lower maximum daily doses)
- •Participation in a concurrent investigational/interventional study (observational studies allowed)
- •Known to be pregnant, or with a positive pregnancy test
- •Allergy or intolerance to the medications used in the PPF-block (i.e., ropivacaine, dexamethasone) or standard pain regimen (APAP)
- •Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
- •Unable to receive first PPF-injection within 96 hours of ictus hemorrhage
研究组 & 干预措施
Group 2 - Placebo - Active
Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
干预措施: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone (Drug)
Group 2 - Placebo - Active
Subjects randomized to Group 2 will receive a placebo PPF-injection in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
干预措施: Placebo Pteryogpalatine Fossa Injection (Procedure)
Group 3 - Placebo - Placebo
Subjects randomized to Group 3 will receive a placebo PPF-injection in Stage 1 followed by a placebo PPF-injection in Stage 2 of the Double-Blinded Trial Phase
干预措施: Placebo Pteryogpalatine Fossa Injection (Procedure)
Group 1 - Active - Active
Subjects randomized to Group 1 will receive an active PPF nerve block in Stage 1 followed by an active PPF nerve block in Stage 2 of the Double-Blinded Trial Phase
干预措施: Pterygopalatine Fossa Nerve Block with Ropivacaine and Dexamethasone (Drug)
结局指标
主要结局
Primary Safety Endpoint
时间窗: at 48 hours from first PPF-injection (end of double-blinded treatment period)
incidence of radiographic vasospasm
Primary Tolerability Endpoint
时间窗: at 24 hours following the first PPF-injection
rate of acceptance of second PPF-injection
Primary Efficacy Endpoint
时间窗: within 24 hours after each PPF-injection spanning the 48 hours of double-blinded treatment period
prn oral morphine equivalent (OME)/day use
次要结局
未报告次要终点