Combination Versus Alone Liposomal Bupivacaine Blocks in Minimally Invasive Thoracic Surgery-1
NCT ID: NCT07254650
Last Updated: 2025-11-28
Study Results
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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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2026-01-01
2028-01-01
Brief Summary
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* 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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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
DOUBLE
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Ability to understand and capacity/willingness to sign a written informed consent form
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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The University of Texas at Dallas
OTHER
Simmons Cancer Center
OTHER
University of Texas Southwestern Medical Center
OTHER
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
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
Countries
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Central Contacts
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Facility Contacts
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Inderpal S Sarkaria, MD, MBA
Role: primary
References
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Other Identifiers
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STU-2025-1629
Identifier Type: -
Identifier Source: org_study_id