Intercostal Cryoneurolysis Following Traumatic Rib Fractures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Inspired Volume
研究概览
简要总结
Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to pulmonary complications and a high degree of morbidity and mortality. Peripheral nerve blocks as well as epidural blocks have been used with success to improve pain control in rib fracture patients and have been associated with decreased pulmonary complications and improved outcomes. However, a single-injection nerve block lasts less than 24 hours; and, even a continuous nerve block is generally limited to 3-4 days. The pain from rib fractures usually persists for multiple weeks or months. In contrast to local anesthetic-induced nerve blocks, a prolonged block lasting a few weeks/months may be provided by freezing the nerve using a process called "cryoneurolysis". The goal of this multicenter, randomized, double-masked, sham-controlled, parallel-arm study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.
详细描述
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective treatment for pain associated with rib fractures; and, if this analgesic modality improves pulmonary mechanics measured with incentive spirometry.
Specific Aim 1: To determine if, compared with current and customary analgesia for rib fracture(s), intercostal nerve cryoneurolysis improves maximum inspiratory volume.
Hypothesis 1a: The maximum inspired volume will be significantly increased on the day following the procedure [primary endpoint] as well as at other time points following the procedure [secondary end points] with intercostal cryoanalgesia as compared single-injection local anesthetic-based intercostal nerve blocks [measured with an incentive spirometer].
Hypothesis 1b: The maximum inspired volume as a percentage of the baseline will be significantly increased on the day following the procedure [secondary endpoint of greatest interest], as well as at other time points following the procedure [secondary end points] with intercostal cryoanalgesia as compared with single-injection local anesthetic-based intercostal nerve blocks [measured with an incentive spirometer].
Specific Aim 2: To determine if, compared with current and customary analgesia, intercostal nerve cryoneurolysis decreases the pain associated with rib fracture(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The randomization lists will be created by the UC San Diego Investigational Drug Service which will create the sealed, opaque randomization envelopes with treatment group assignments. The treating investigators doing the procedures will be the only other individuals aware of the treatment group assignments. The Investigational Drug Service will not provide the treatment group assignments to the investigators until the completion of data collection for all subjects; and will only provide "Treatment A" vs "Treatment B" assignments for the initial statistical analysis. Only at the completion of statistical analysis will each treatment be revealed to the investigators.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of at least 18 years of age
- •having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint sustained within the previous 3 days (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
- •regional anesthetic requested by the admitting service
- •accepting of a cryoneurolysis procedure
排除标准
- •chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks
- •pregnancy
- •incarceration
- •inability to communicate with the investigators
- •morbid obesity (body mass index > 40 kg/m2)
- •possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
- •any patient unable to correctly perform incentive spirometry as this is the primary outcome measure
- •any patient with any degree of decreased mental capacity as determined by the surgical service
- •any reason an investigator believes study participation would not be in the best interest of the potential subject
- •flail chest
- •chest tube
- •fracture of the 1st rib on either side
- •any moderate or severe pain (NRS>3) unrelated to the rib fracture(s), as best determined by the patient and investigator
研究组 & 干预措施
Cryoneurolysis and placebo intercostal nerve block
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
干预措施: Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas) (Device)
Cryoneurolysis and placebo intercostal nerve block
Active cryoneurolysis: 3 mL of normal SALINE will be injected into the muscle superficial to the nerve followed by an ACTIVE cryoneurolysis procedure using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
干预措施: Placebo intercostal nerve block with normal saline (Drug)
Sham cryoneurolysis and active intercostal nerve block
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
干预措施: Intercostal nerve block ropivacaine with epinephrine (Drug)
Sham cryoneurolysis and active intercostal nerve block
Sham cryoneurolysis: 3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block followed by a SHAM cryoneurolysis procedure with a probe that vents the nitrous oxide prior to reaching the probe tip using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods.
干预措施: Sham cryoneurolysis with a Painblocker (Device)
结局指标
主要结局
Maximum Inspired Volume
时间窗: Day 1 of study treatment
maximum inspired volume measured on a handheld incentive spirometer based on the American Association of Respiratory Care (AARC) clinical practice guideline.\[Restrepo. Respirated Care 2011\] The best of three measurements will be recorded as the maximum inspired volume.
次要结局
- Maximum Inspired Volume(Days 0, 1, 2, 7, 14, and Months 1, 1.5, and 2)
- Spirometry Pain(Days 0, 1, 2, 7, 14, and Months 1, 1.5, and 2)
- Brief Pain Inventory (Pain Scale)(Days 1, 2, and 7)
- Brief Pain Inventory (Interference Scale)(Day 14, and Months 1, 1.5, 2, 3, 6, and 12)
- Sleep Disturbances Due to Pain(Days 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12)
- Oral Opioid Consumption(Days 1, 2, 7, 14; Months 1, 1.5, 2, 3, 6, and 12)
- Intravenous Opioid Consumption(Days 1, 2, 7, 14)
- Day of Discharge(through study completion, an average of 1 year)
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego