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

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Lung Cancer (Diagnosis)

Treatments: Procedure: Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block; Procedure: Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block; Procedure: Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07254650

STU-2025-1629

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

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

Experimental group

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.

Treatment:

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 group

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.

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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