Combination Versus Alone Liposomal Bupivacaine Blocks in Minimally Invasive Thoracic Surgery-1

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block
  The anesthetic mixture is prepared by combining 266 mg (20 mL) of Liposomal Bupivacaine (Exparel®) with 50 mg (20 mL) of 0.25% Bupivacaine Hydrochloride, creating a mixture of 40 mL. This mixture is administered via multi-level intercostal nerve block (ICNB). One injection is administered by a surgeon per intercostal space (ICS), given at the origin of the nerve space junction where the nerve and the inferior aspect of the rib meet after the nerve immerges from the intervertebral foramina. At l
• Процедура Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block
  The anesthetic mixture is prepared by combining 266 mg (20 mL) of Liposomal Bupivacaine (Exparel®) with 50 mg (20 mL) of 0.25% Bupivacaine Hydrochloride, creating a mixture of 40 mL. This mixture is administered via serratus anterior plane block. One injection is administered by an anesthesiologist in the serratus anterior fascial plane, immediately prior to incision while in the operating room. The total volume of 40 mL is administered using a single-shot technique with a short-bevel, 21-guage
• Процедура Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block
  Patients randomized to Arm 3 will receive both a multi-level intercostal nerve block (ICNB) and a serratus anterior plane block (SAPB), with each containing half the dose of Liposomal Bupivacaine (LipoB) as compared to when administered as a single block in Arm 1 and Arm 2. The mixtures are as follows: 133mg (10mL) LipoB mixed with 25mg (10mL) 0.25% Bupivacaine Hydrochloride and 20mL of saline administered as SAPB by anesthesiologist immediately prior to incision while in the operating room AN

Первичные конечные точки

• NRS AUC 72 [Срок оценки: Post-operative day 0 to post-operative day 3 (if still present in the hospital)]
• Numeric Rating Scale (NRS) [Срок оценки: Post-operative day 0 to post-operative day 3 (if still present in the hospital)]

Вторичные конечные точки (9)

• Quality-of-Life (Measured by Quality of Recovery Scale) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Post-operative day 0 up to 14 days post-operation]
• Cognitive Function via Neurologic Electrical Response [Срок оценки: 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 [Срок оценки: Post-operative day 0 up to 14 days post-operation]
• Adverse Events [Срок оценки: Post-operative day 0 to clinic follow-up at 2-5 weeks post-operatively]
• Length of Stay [Срок оценки: From date of hospital admission for surgical procedure until date of discharge from hospital, assessed up to 104 weeks.]
• Cost-of-Care [Срок оценки: Peri-operative, assessed up to 2 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Clements University Hospital at University of Texas Southwestern Medical Center — Dallas

Публикации

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• Zhang Y, Xian X, Wang F, Zhou B, Wang Y, Wang P, Li Y, Wu Y. Opioid-Free Anesthesia Improved the Quality of Recovery After Thyroidectomy Through Pre-Emptive and Preventive Analgesia: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 Jun 19;19:5243-5254. doi: 10.2147/DDDT.S520856. eCollection 2025. PMID 40552090
• Xu HT, Zimmerman J, Bertoch T, Chen L, Chen PJ, Onel E. CPL-01, an investigational long-acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair. Hernia. 2024 Aug;28(4):1345-1354. doi: 10.1007/s10029-024-03047-3. Epub 2024 May 7. PMID 38713429
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Идентификаторы

NCT: NCT07254650 · STU20251629

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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