Randomized Prospective Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Acute Unilateral Rib Fracture Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption
研究概览
简要总结
Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic pain following surgery and trauma. Recently, an increasing number of erector spinae plane blocks are being performed as it has been demonstrated in our institution and via case reports that they provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block. However, the relative efficacy of ESP and continuous paravertebral analgesia for patients with rib fractures remains to be established. This study will include 60 consecutive patients presenting to the UPMC Presbyterian Acute Interventional Perioperative Pain Service suffering from unilateral rib fractures and will be randomized to receive either nerve blocks via continuous paravertebral infusion or via erector spinae plane infusion. In addition, to treat breakthrough pain, the patients in both arms will receive multimodal adjunctive therapy per routine. Bupivicaine and ropivicaine are FDA approved for use in nerve block catheters. The primary outcome will be total opioid consumption in the first 3 days of nerve block. Secondary outcomes include highest visual analog pain score (VAS) with deep breathing and at rest, adverse events, and total number of nerve blocks. Other data points include time to readiness for discharge, and length of hospital stay.
详细描述
All interventions regarding the placement and management of ESP and paravertebral blocks in this study are consistent with existing standard of care practices at UPMC and utilize protocols that are already in use. In addition, by nature of being included in a research study, patients are likely to receive closer monitoring for side-effects.
Screening and enrollment: After approval by the institutional review board, all (American Society of Anesthesiology) ASA I-IV patients aged 18-85 years, weighing between 50 and 120 kg with unilateral rib fractures will be screened for enrollment. Sixty patients will be enrolled in this randomized prospective study with equal numbers in each arm of the trial. This study design is unblinded as we cannot blind patients nor observers as to the type of block performed (slightly different location). This is an accepted limitation of the study. No advertising will be used and no monetary compensation will be offered. The nature of the study, planned interventions, risks, benefits, and alternatives will be discussed in detail with the patients at the time of enrollment and prior to the patients' signing of a written consent form.
Randomization: Patients will be enrolled into one of the study groups on the day of consultation in an alternating fashion. The study groups are defined as: Group I: Erector Spinae Plane Block (ESP) 30 patients Group II: Paravertebral Block (PVB) 30 patients.
Day of Block: After written informed consent is confirmed, a research assistant will introduce the scoring system used for pain assessment (VAS), and demonstrate proper use of the incentive spirometer.
All nerve blocks will be performed by an experienced member of UPMC's pain management service. Both nerve blocks can take between 10-60 minutes to perform. They will either occur in the ICU or on a monitored medicine floor.
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
- None
盲法说明
We are unable to mask the patient or provider for this study. The interventions are inherently similar, but different, thus making it impossible to blind.
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
- •Age between 18-85 years
- •no contraindications to the placement of a paravertebral catheter or erector spinae plane catheter
- •American Society of Anesthesiologists physical status between I-IV
- •no chronic opioid use
- •patients who are not expected to be on therapeutic anticoagulants post-procedurally
- •no clopidogrel in last 48 hours
- •no known allergies to any of the drugs/agents used study protocol
- •no personal or family history of malignant hyperthermia
- •not pregnant
- •not having an altered mental status (oriented to place, person, or time)
- •no comorbid condition(s) that in the judgment of the anesthesiologist, would preclude the patient from any aspect of the study. Comorbid conditions include bleeding disorders, thrombocytopenia, localized infection, sepsis, possibly abnormalities of the thoracic spine or paravertebral anatomy neoplastic mass occupying the paravertebral space, empyema, allergy to local anesthestic drug, increased intracranial pressure, severe uncorrected hypovolemia, fixed cardiac output states.
排除标准
- •Age younger than 18 years or older than 85 years
- •any contraindication to the placement of a paravertebral or erector spinae catheters
- •American Society of Anesthesiologists physical status V or greater
- •chronic opioid use
- •coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postprocedurally
- •clopidogrel use within 48 hours
- •allergy to any of the drugs/agents used study protocol
- •personal or family history of malignant hyperthermia
- •pregnancy
- •having an altered mental status (not oriented to place, person, or time), (11) any comorbid condition that in the judgment of the anesthesiologist would preclude the patient from any aspect of the study
- •patient refusal. Comorbid conditions include bleeding disorders, thrombocytopenia, localized infection, sepsis, possibly abnormalities of the thoracic spine or paravertebral anatomy neoplastic mass occupying the paravertebral space, empyema, allergy to local anesthetic drug, increased intracranial pressure, severe uncorrected hypovolemia, fixed cardiac output states.
研究组 & 干预措施
Erector Spinae Plane Block
The patients randomized to the Erector Spinae Plane Block arm will receive this nerve block at the level corresponding to the rib fractures. Ropivicaine 0.5% 25 mL will be used during the procedure for initiation of pain control. Bupivicaine 0.0625% will be used for continuous infusion of local anesthetic. It will be titrated to effect, at maximum 12 mL/hr. Bupivicaine 0.0625% 3mL will be given every hour as a bolus additionally.
干预措施: Erector Spinae Plane Block (Drug)
Paravertebral Nerve Block
The patients randomized to the Paravertebral Nerve Block arm will receive this nerve block at the level corresponding to the rib fractures. Ropivicaine 0.5% 25 mL will be used during the procedure for initiation of pain control. Bupivicaine 0.0625% will be used for continuous infusion of local anesthetic. It will be titrated to effect, at maximum 12 mL/hr. Bupivicaine 0.0625% 3mL will be given every hour as a bolus additionally.
干预措施: Paravertebral Nerve Block (Drug)
结局指标
主要结局
Total Opioid Consumption
时间窗: first 72 hours after intervention
次要结局
- Number of Nerve Blocks(During the expected duration of this study, which is on average 5 days.)
- Length of Stay(Will evaluate length of stay upon termination of the last study subject. Expected to be within 6 months of initiation of the trial.)
- Visual Analog Scale (VAS) Pain Scores(Immediately prior to intervention. 15 minutes after intervention. 60 minutes after intervention. Daily (in morning) for 3 total days after intervention.)
- Adverse Events(During the expected duration of this study, which is on average 5 days.)
- Time until discharge(Will evaluate length of stay upon termination of the last study subject. Expected to be within 6 months of initiation of the trial.)
研究者
Samuel Goldstein
Anesthesia Resident
University of Pittsburgh