Comparison Of Ultrasound-Assisted Paravertebral Block And Traditional Paravertebral Block For Pain Control After Thoracic Surgery, A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Opioid Consumption at 24 Hours Postoperatively
研究概览
简要总结
The overall purpose of this research study is to compare the effectiveness of ultrasound assisted paravertebral block placement versus traditional "blind" technique for postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery.
详细描述
The purpose of this project is to determine if there is a difference between paravertebral block performed with ultrasound assistance and paravertebral block performed with traditional technique in terms of twenty - four hour hydromorphone (dilaudid) consumption and visual analogue pain scores at rest or with deep breathing at twenty - four hours. This study will determine if ultrasound technique used for placement of paravertebral catheter facilitates safety of paravertebral catheterization and improves therapeutic effect of paravertebral blockade for pain control after thoracotomy. The investigators will also examine if ultrasound assisted paravertebral blockade improves pulmonary status in post-thoracotomy patient.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) I-III subjects
- •Ages 18-75 years
- •Scheduled for elective thoracic surgery at University of Pittsburgh Medical Center (UPMC) Passavant and Shadyside Hospitals in Pittsburgh, Pennsylvania
- •Patients willing and able to provide informed consent
排除标准
- •Age younger than 18 years or older than 75 years
- •(2) Any contraindication to the placement of unilateral thoracic paravertebral catheter, including local infection, hypocoagulable state.
- •(3) American Society of Anesthesiologists physical status IV or greater
- •(4) chronic painful conditions
- •(5) preoperative opioid use
- •(6) coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
- •(7) allergy to lidocaine, ropivacaine or bupivacaine
- •(8) personal or family history of malignant hyperthermia
- •(9) serum creatinine greater than 1.4 g/dl
- •(10) pregnancy or lactating.The pregnancy status will be determined by history and prior pregnancy testing when appropriate
- •(11) having an altered mental status (not oriented to place, person, or time) or emergency surgery
- •(12) comorbid conditions such as sepsis, unstable angina, congestive heart failure, moderate to severe valvular heart disease, severe chronic obstructive pulmonary disease (COPD)
- •(13) patient's inability to provide adequate informed consent
- •(14) patient refusal to nerve blocks and/or participation in the study
- •(15) respiratory support via ventilator post
- •(16) non English speaking
- •(17) allergy to contrast of iodine
- •(18) emergency surgery or any other non-elective procedure
- •(19) unstable vertebral and transverse process fractures
研究组 & 干预措施
Traditional approach paravertebral nerve block
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
干预措施: Thoracotomy (Procedure)
Traditional approach paravertebral nerve block
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
干预措施: Video-Assisted Thoracoscopic Surgery (VATS) (Procedure)
Ultrasound assisted paravertebral nerve block
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
干预措施: Thoracotomy (Procedure)
Ultrasound assisted paravertebral nerve block
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
干预措施: Video-Assisted Thoracoscopic Surgery (VATS) (Procedure)
结局指标
主要结局
Opioid Consumption at 24 Hours Postoperatively
时间窗: 24 hours after patient-controlled analgesia (PCA) was initiated
Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).
次要结局
- Number of Local Anesthetic Boluses Requested by PCA(24 hours postoperatively)
- Total Local Anesthetic Infusions Over 24- Hour Period(24 hours postoperatively)
- Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)(Pre-operatively and at 24 hour post-operative)
- Incentive Spirometry(Preoperatively and Postoperatively)
- Respiratory Rate(24 hours postoperatively)
- Forced Vital Capacity (FVC)(Preoperatively and postoperatively)
- Sensory Level(6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.)
- Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing(24 hours post PCA initiation)
- Forced Expiratory Volume in 1 Sec (FEV1)(Preoperatively and postoperatively)
- Peak Expiratory Flow Rate(PEF)(Preoperatively and postoperatively)
- Total Number of Local Anesthetic Boluses in 24 Hours(postoperatively, up to 24 hours)
研究者
Anna Uskova
Clinical Assistant Professor
University of Pittsburgh