Pain Control in Minimally Invasive Lung Cancer Surgery

This study is looking at different ways to manage pain after minimally invasive lung cancer surgery. Researchers are comparing three approaches using a long-acting pain medication called Liposomal Bupivacaine (Exparel®). You might receive Exparel® as an intercostal nerve block (targeting nerves between your ribs), a serratus anterior plane block (targeting nerves in your chest wall), or a combination of both. The main goal is to see which method best reduces pain during the first few days after surgery. They also want to understand how these pain control methods affect your hospital stay, costs, and overall quality of life. Adults aged 18 and older who are having elective minimally invasive lung surgery are eligible to participate.

Study design
This interventional study plans to enroll 300 participants. It compares three different ways of giving pain medication after surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain levels will be measured from the day of surgery up to three days after, if you are still in the hospital.

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NCT07254650

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~300 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve BlockArm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane BlockArm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
NRS AUC 72
Measured over Post-operative day 0 to post-operative day 3 (if still present in the hospital)
+1 more outcome measured
Lung Cancer (Diagnosis)
1 sites across 1 states
Texas1
  • Inderpal S Sarkaria, MD, MBA · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

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

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
  • NRS AUC 72Post-operative day 0 to post-operative day 3 (if still present in the hospital)

    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.

  • Numeric Rating Scale (NRS)Post-operative day 0 to post-operative day 3 (if still present in the hospital)

    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.