Clinical trial · Interventional
Combination Versus Alone Liposomal Bupivacaine Blocks in Minimally Invasive Thoracic Surgery-1
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block | Procedure | — | UNRESOLVED |
| Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block | Procedure | — | UNRESOLVED |
| Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block
- description
- 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.
- interventionNames
- Procedure: Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block
- type
- EXPERIMENTAL
- label
- Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block
- description
- 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.
- interventionNames
- Procedure: Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (58)
- BACKGROUNDXu HT, Zimmerman J, Bertoch T, Chen L, Chen PJ, Onel E. Efficacy, safety, and pharmacokinetics of CPL-01, an investigational long-acting ropivacaine, in bunionectomy: Results of a phase 2b study. J Foot Ankle Surg. 2025 Mar-Apr;64(2):150-156. doi: 10.1053/j.jfas.2024.09.007. Epub 2024 Sep 19. PMID 39303759
- BACKGROUNDZhang 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
- BACKGROUNDXu 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
- BACKGROUNDAdministration, U. S. F. a. D. (2022). Statistical Review and Evaluation: P211988Orig1s000StatR. (P211988Orig1s000). U.S. Food and Drug Administration Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/211988Orig1s000StatR.pdf?utm_source
- BACKGROUNDLang-Illievich K, Wejbora M, Szilagyi IS, Bornemann-Cimenti H. A novel metric for reporting acute postoperative pain correlates more closely with patient satisfaction. Br J Anaesth. 2020 Jun;124(6):e228-e229. doi: 10.1016/j.bja.2020.02.011. Epub 2020 Mar 19. No abstract available. PMID 32199586
- BACKGROUNDViscusi E, Gimbel JS, Pollack RA, Hu J, Lee GC. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019 May 21:rapm-2019-100531. doi: 10.1136/rapm-2019-100531. Online ahead of print. PMID 31113830
- BACKGROUNDKannampallil T, Galanter WL, Falck S, Gaunt MJ, Gibbons RD, McNutt R, Odwazny R, Schiff G, Vaida AJ, Wilkie DJ, Lambert BL. Characterizing the pain score trajectories of hospitalized adult medical and surgical patients: a retrospective cohort study. Pain. 2016 Dec;157(12):2739-2746. doi: 10.1097/j.pain.0000000000000693.