A Phase IIb, Randomized, Double-Blinded, Three-Arm Clinical Trial: The Study of Liposomal Bupivacaine Via Intercostal Nerve Block, Serratus Anterior Plane Block, or Combination Block for Pain Control After Robotic Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- NRS AUC 72
研究概览
简要总结
The goal of this clinical trial is to assess how the location of local anesthetic medication affects pain control capabilities in adult patients undergoing thoracic(chest)-only minimally invasive surgery. The main questions it aims to answer are:
- Is pain decreased when local analgesia is provided as a combination of serratus anterior plane block and intercostal nerve block when compared to either block administered individually?
- How does location of local analgesia administration impact length-of-stay, cost-of-care, and quality-of-life?
Researchers will compare three treatment options including long-acting local anesthetic (Exparel®) administered as (1) intercostal nerve block, (2) serratus anterior plane block, or (3) combination of intercostal nerve block and serratus anterior plane block to see if pain and opioid use are reduced dependent upon treatment group.
All participants will receive a local anesthetic nerve block. Participants will be asked to describe their pain after surgery and to answer various questionnaires before and after surgery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patient and outcomes-assessors (floor or ICU nurses, research nurses, any person administering study questionnaires) will be blinded. Provider administering regional block (surgeon or anesthesiologist) will not be blinded but will not collect post-operative outcomes data.
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
- •Plan to undergo planned (elective) minimally invasive isolated R-VATS procedure, to include pulmonary anatomic resections (anatomic lobectomy, segmentectomy, and wedge resection if performed robotically)
- •Age ≥ 18 years old
- •Ability to understand and capacity/willingness to sign a written informed consent form
排除标准
- •Age < 18 years old
- •Unwilling to sign informed consent form, mentally challenged/delayed, or lacking capacity/unable to consent to participation in the trial own their own behalf
- •Vulnerable populations
- •Incarcerated individuals
- •Pregnant individuals
- •Breastfeeding individuals
- •Individuals with potentially altered pharmacokinetics and metabolism of study drugs
- •Renal failure: creatinine ≥ 2, or glomerular filtration rate < 45 mL/min
- •Hepatic failure: serum ammonia > 33 mcg/dL and/or Child-Pugh > A
- •Individuals suffering from chronic pain
- •Individuals taking pre-operative narcotics
- •Patients undergoing emergent surgery or urgent surgery for acute, traumatic injuries
- •Patients undergoing extra-pleural resections, chest wall resection, pleurectomies, pleurodesis, and decortications
- •Planned concurrent abdominal procedure: for example, but not limited to, an esophagectomy
- •Patients requiring subcostal transversus abdominis plane (TAP) block
- •Use of a rib spreader during thoracic procedure
- •Patients admitted to the intensive care unit (ICU) post-operatively while sedated and intubated
- •Patients with major post-operative complications
- •Wedge resection for pulmonary bleb
- •Unanticipated pleurectomy, even if partial
- •Surgeon injects superficial wounds with LipoB
研究组 & 干预措施
Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block
Patients randomized to Arm 1 "LipoB-I" will receive Liposomal Bupivacaine (LipoB) as an intra-operative multi-level intercostal nerve block containing 266mg (20mL) of Liposomal Bupivacaine (Exparel®) combined with 50mg (20mL) of 0.25% Bupivacaine Hydrochloride, for a total of 40mL for the block.
干预措施: Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block (Procedure)
Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block
Patients randomized to Arm 2 "LipoB-S" will receive Liposomal Bupivacaine (LipoB) as an intra-operative serratus anterior plane block containing 266mg (20mL) of Liposomal Bupivacaine (Exparel®) combined with 50mg (20mL) of 0.25% Bupivacaine Hydrochloride, for a total of 40mL for the block.
干预措施: Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block (Procedure)
Arm 3 "LipoB-C": Liposomal Bupivacaine via Combination Block
Patients randomized to Arm 3 "LipoB-C" will receive Liposomal Bupivacaine (LipoB) as an intra-operative combination block (multi-level intercostal nerve block [ICNB] and serratus anterior plane block [SAPB]) with half the dose of Liposomal Bupivacaine administered in each block. Block solutions are as follows:
10mL LipoB mixed with 10mL 0.25% Bupivacaine Hydrochloride and 20mL of saline, administered as SAPB by anesthesiologist immediately prior to incision while in the operating room
AND
10mL LipoB mixed with 10mL 0.25% Bupivacaine Hydrochloride and 20mL of saline administered as ICNB prior to closure in at least 5 intercostal spaces as determined by administering surgeon while in the operating room.
干预措施: Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block (Procedure)
结局指标
主要结局
NRS AUC 72
时间窗: Post-operative day 0 to post-operative day 3 (if still present in the hospital)
The investigators will obtain the NRS NRS AUC 72 (units: NRS·hours) (units 0-10) from time 0, entry into the recovery room, to 72 hours after entry into the recovery room. Pain will be assessed by the nursing staff, typically every 4 hours, and by research staff at least once on post-operative days 1-3. The times t0,t1,…,tk in hours within the range of 0 to 72 hours will correspond to NRS scores y0,y1,…,yk. Using the trapezoidal rule over the observed interval (assuming irregular and irregular timing), where: AUC=∑i((yi+yi+1)/2)(ti+1-ti), the maximum NRS·hours would be 10 x 72 hours + 720. If an individual patient measurement is taken off-schedule, the actual time stamps will be utilized. The trapezoidal rule naturally accommodates irregular spacing. If a patient is discharged early, or there is missing data, the AUC will be computed over the observed intervals and reported as time-standardized AUC = (AUC over observed time)/observed hours x 72.
Numeric Rating Scale (NRS)
时间窗: Post-operative day 0 to post-operative day 3 (if still present in the hospital)
A pain numeric rating scale will be administered to all patients in the trial from post-operative day 0 to post-operative day 3 in the hospital. Study personnel will gather a NRS value once a day for post-operative day 1-3 and nursing staff will gather a NRS value multiple times a day, typically every 4 hours, per their protocol. Average and maximum values (Likert scale 0-10) will be recorded each day.
次要结局
- Quality-of-Life (Measured by Quality of Recovery Scale)(Post-operative day 1 to post-operative day 3 (if still present in the hospital), as well as at clinic follow-up at 2-5 weeks and via telephone at 90, 180, and 365 days post-operatively)
- Pain Interference via PROMIS Pain Interference (PROMIS-PI)(Clinic follow-up at 2-5 weeks and via telephone at 90, 180, and 365 days post-operatively)
- Quality of Sleep via PROMIS Sleep Disturbance Short Form (SF)(Post-operative day 1, as well as at clinic follow-up at 2-5 weeks and via telephone at 90, 180, and 365 days post-operatively)
- Opioid Usage(Post-operative day 0 up to 14 days post-operation)
- Cognitive Function via Neurologic Electrical Response(During surgery (intra-operative EEG) with follow-up assessments (minimal mental state exams) post-operatively up to 14 days post-operation.)
- Respiratory Function via Incentive Spirometry(Post-operative day 0 up to 14 days post-operation)
- Adverse Events(Post-operative day 0 to clinic follow-up at 2-5 weeks post-operatively)
- Length of Stay(From date of hospital admission for surgical procedure until date of discharge from hospital, assessed up to 104 weeks.)
- Cost-of-Care(Peri-operative, assessed up to 2 weeks.)
研究者
Inderpal Sarkaria
Chief of the Division of Thoracic Surgery and Professor of Thoracic Surgery at University of Texas Southwestern Medical Center, and Robert Tucker Hayes Foundation Distinguished Chair in Cardiothoracic Surgery
University of Texas Southwestern Medical Center