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

NCT07254650 | Not Yet Recruiting DMC

• 1 other identifier: STU-2025-1629
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer (Diagnosis)

Keywords

Exparel®; Liposomal Bupivacaine; Multi-Level Intercostal Nerve Block; Serratus Anterior Plane Block; Robotic-Assisted Thoracic Surgery; Adult; Pulmonary Wedge Resection; Lobectomy; Pulmonary Segmentectomy; Pneumonectomy; Minimally-Invasive Thoracic Surgery; Pain Control; Regional Anesthetic Block

Outcome Measures

Primary Outcomes (2)

• NRS AUC 72

  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.

  Post-operative day 0 to post-operative day 3 (if still present in the hospital)

• Numeric Rating Scale (NRS)

  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.

  Post-operative day 0 to post-operative day 3 (if still present in the hospital)

Secondary Outcomes (9)

• 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.

Study Arms (3)

Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block

EXPERIMENTAL

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.

Procedure: Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block

Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block

EXPERIMENTAL

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.

Procedure: Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block

Arm 3 "LipoB-C": Liposomal Bupivacaine via Combination Block

EXPERIMENTAL

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.

Procedure: Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block

Interventions

Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block PROCEDURE

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 least 5 mL, and no more than 8mL, will be injected in each ICS with the ideal injection consisting of 3 mL just beneath the pleura and 5 mL deeper in the intercostal muscular tissue for a total of 8 mL per ICS. Injections will be completed utilizing a 21-guage needle and two 20-mL syringes.

Also known as: Exparel, Multi-Level Intercostal Nerve Block, 0.25% Bupivacaine Hydrochloride, Marcaine

Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block

Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block PROCEDURE

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 needle, ensuring a negative aspiration for blood upon entry, no paresthesia on injection, and incremental injection under ultrasound guidance.

Also known as: Exparel, Marcaine, Serratus Anterior Plane Block, 0.25% Bupivacaine Hydrochloride

Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block

Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block PROCEDURE

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 AND 133mg (10mL) LipoB mixed with 25mg (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.

Also known as: Exparel, Marcaine, 0.25% Bupivacaine Hydrochloride, Combination Block

Arm 3 "LipoB-C": Liposomal Bupivacaine via Combination Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• The University of Texas at Dallas: collaborator
• Simmons Cancer Center: collaborator

Study Sites (1)

Clements University Hospital at University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

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• Pedoto A, Noel J, Park BJ, Amar D. Liposomal Bupivacaine Versus Bupivacaine Hydrochloride for Intercostal Nerve Blockade in Minimally Invasive Thoracic Surgery. J Cardiothorac Vasc Anesth. 2021 May;35(5):1393-1398. doi: 10.1053/j.jvca.2020.11.067. Epub 2020 Dec 2.

  PMID: 33376072 BACKGROUND

• Marciniak DA, Alfirevic A, Hijazi RM, Ramos DJ, Duncan AE, Gillinov AM, Ahmad U, Murthy SC, Raymond DP. Intercostal Blocks with Liposomal Bupivacaine in Thoracic Surgery: A Retrospective Cohort Study. J Cardiothorac Vasc Anesth. 2021 May;35(5):1404-1409. doi: 10.1053/j.jvca.2020.09.116. Epub 2020 Sep 22.

  PMID: 33067088 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Disease; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Inderpal S Sarkaria, MD, MBA

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inderpal S Sarkaria, MD, MBA

CONTACT

214-645-7700; Inderpal.Sarkaria@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: The 3 treatment arms are as follows for intra-operative injection of Liposomal Bupivacaine (LipoB) as a regional anesthetic block: * Arm 1: Entire dose (20mL) of LipoB and (20mL) Marcaine® injected locally via multi-level intercostal nerve block (ICNB) * Arm 2: Entire dose (20mL) of LipoB and (20mL) Marcaine® injected regionally as serratus anterior plane block (SAPB) * Arm 3: Half dose (10mL) of LipoB and (10mL) Marcaine® mixed with 20cc saline injected as ICNB, half dose (10mL) of LipoB and (10mL) Marcaine® mixed with 20cc saline injected as SAPB.

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (1)