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

NCT ID: NCT07254650

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer (Diagnosis)

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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 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.

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

Other Intervention Names

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Exparel Multi-Level Intercostal Nerve Block 0.25% Bupivacaine Hydrochloride Marcaine Exparel Marcaine Serratus Anterior Plane Block 0.25% Bupivacaine Hydrochloride Exparel Marcaine 0.25% Bupivacaine Hydrochloride Combination Block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas at Dallas

OTHER

Sponsor Role collaborator

Simmons Cancer Center

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inderpal S Sarkaria, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Clements University Hospital at University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Inderpal S Sarkaria, MD, MBA

Role: CONTACT

Phone: 214-645-7700

Email: [email protected]

Facility Contacts

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Inderpal S Sarkaria, MD, MBA

Role: primary

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU-2025-1629

Identifier Type: -

Identifier Source: org_study_id