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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be asked to describe their pain after surgery and to answer various questionnaires before and after surgery."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether long-acting numbing medicine (Exparel) works better near the ribs, along the side of the chest, or in both places. It is for adults having planned, robot-assisted chest surgery through small cuts. Researchers will compare pain, opioid pain medicine use, hospital stay, care costs, and quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Scheduled for planned, robot-assisted surgery through small cuts in the chest only, including removal of part of a lung.
  • Able to understand the study and willing and able to sign a consent form.

Who can't join

  • Under 18, unable or unwilling to give consent on your own, in prison, or part of a group the study lists as vulnerable.
  • Pregnant or breastfeeding.
  • Problems that may change how your body handles the study drugs, including kidney or liver failure based on the study’s test limits.
  • Long-term pain or use of opioid pain medicines before surgery.
  • Emergency surgery or urgent surgery for a sudden injury; planned belly surgery at the same time; or removal of a small piece of lung for an air blister.
  • Surgery involving removal of the chest wall, chest lining, or tissue outside that lining; sealing the lung to the chest wall; or removing scar tissue around the lung. Unexpected removal of any chest lining also rules you out.
  • Need for a numbing block below the ribs in the belly wall, use of a tool to spread the ribs, or the surgeon injecting liposomal bupivacaine into surface wounds.
  • Major problems after surgery, or an intensive care unit stay after surgery while sedated and on a breathing tube.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

TX