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Lung Cancer (Diagnosis)CALMS-1NCT07254650

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

A study testing Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block, Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block and Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block in people with Lung Cancer (Diagnosis), run by University of Texas Southwestern Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer (Diagnosis)
What is being tested?
Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block, Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block and Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Oct 2026to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Inderpal S Sarkaria, MD, MBA contact

214-645-7700

Inderpal.Sarkaria@utsouthwestern.edu

United States1 site

  • Clements University Hospital at University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Inderpal S Sarkaria, MD, MBA, 214-645-7700, Inderpal.Sarkaria@utsouthwestern.edu

    Inderpal S Sarkaria, MD, MBA

Other trials in United States

About this study

Official title: 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

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?
Read more

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.

Being tested
Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block, Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block, Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block
Keywords
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
Medical subject headings
Lung Neoplasms, Disease, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve BlockProcedure or surgery

    Also called Exparel, Multi-Level Intercostal Nerve Block, 0.25% Bupivacaine Hydrochloride, Marcaine

    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 BlockProcedure or surgery

    Also called Exparel, Marcaine, Serratus Anterior Plane Block, 0.25% Bupivacaine Hydrochloride

    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 BlockProcedure or surgery

    Also called Exparel, Marcaine, 0.25% Bupivacaine Hydrochloride, 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.

Study groups in NCT07254650
Study groupRoleWhat they receive
Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve BlockExperimentalPatients 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.
Receives: Procedure: Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block
Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane BlockExperimentalPatients 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.
Receives: Procedure: Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block
Arm 3 "LipoB-C": Liposomal Bupivacaine via Combination BlockExperimentalPatients 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.
Receives: Procedure: Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NRS AUC 72

    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.

    Measured: Post-operative day 0 to post-operative day 3 (if still present in the hospital)

  2. Numeric Rating Scale (NRS)

    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.

    Measured: Post-operative day 0 to post-operative day 3 (if still present in the hospital)

Secondary outcomes (9)

  1. Quality-of-Life (Measured by Quality of Recovery Scale)

    Investigators will measure post-operative side effects, functional status, and quality-of-life using the Quality of Recovery 15 scale (QR-15). The QR-15 scale measures pain as well as patient daily functioning, enjoyment, relationships, and overall well-being. The QR-15 has previously been validated among the minimally-invasive Thoracic Surgery population, with large-scale studies demonstrating significantly different medial QR-15 scores before to after surgery, with the QR-15 showing significant negative correlations with pain intensity and during coughing in the post-operative period. Further, the pain dimension of the QR-15 correlated to patient "emotional state, physical comfort, and physical independence" at 24, 48, and 72 hours post-operatively. QR-15 may assess nausea, appetite, constipation, and fatigue levels, as well as return to baseline function including return to oral intake, bowel function and ambulation. This scale is favored in clinical use by many anesthesiologists.

    Measured: Post-operative day 1 to post-operative day 3 (if still present in the hospital), as well as at clinic follow-up at 2-5 weeks and via telephone at 90, 180, and 365 days post-operatively

  2. Pain Interference via PROMIS Pain Interference (PROMIS-PI)

    The PROMIS Pain Interference item banks assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The pain interference short forms are universal rather than disease-specific. All assess pain interference over the past seven days.

    Measured: Clinic follow-up at 2-5 weeks and via telephone at 90, 180, and 365 days post-operatively

  3. Quality of Sleep via PROMIS Sleep Disturbance Short Form (SF)

    The PROMIS Sleep Disturbance-SF questionnaire will be administered on post-operative day 1, as well as during clinic and telephone follow-up. This questionnaire assesses overall quality of sleep.

    Measured: Post-operative day 1, as well as at clinic follow-up at 2-5 weeks and via telephone at 90, 180, and 365 days post-operatively

  4. Opioid Usage

    All opioid usage-including medication type, dosage, and time of administration- will be documented in the medical record. Opioid usage will be converted in a standard fashion to morphine milligram equivalents (MME) per day which will be recorded for all patients. Total cumulative opioid consumption will also be noted. This data will allow the research team to note time until first opioid use after surgery, time until cessation of opioid use after surgery, and whether a patient is utilizing opioids at time of discharge.

    Measured: Post-operative day 0 up to 14 days post-operation

  5. Cognitive Function via Neurologic Electrical Response

    Study subjects will undergo processed electroencephalogram (EEG) monitoring during the procedure. This requires an EEG sensor strip to be placed across the forehead. The use of processed EEG is standard-of-care for anesthesia monitoring during VATS or R-VATS procedures. EEG monitoring intra-operatively will assess neurologic electrical response to treatments (medications, regional nerve blocks, etc.) administered while in the operating room. The anesthesiology team will examine minimal mental state post-operatively per routine care.

    Measured: During surgery (intra-operative EEG) with follow-up assessments (minimal mental state exams) post-operatively up to 14 days post-operation.

  6. Respiratory Function via Incentive Spirometry

    An incentive spirometer is a handheld device provided to surgical patients to encourage deep, slow breathing, physiologically re-expanding alveoli that may have collapsed due to under-recruitment during and after surgery. Incentive spirometry maximum volume (mL) is recorded daily as the standard-of-care. Maximum incentive spirometry volume will be noted as a secondary outcome measure as the ability to take deep breaths is often directly correlated to thoracic and chest wall pain.

    Measured: Post-operative day 0 up to 14 days post-operation

  7. Adverse Events

    All post-operative complications will be documented. All adverse reactions to medications will also be documented. The most common adverse reactions associated with liposomal Bupivacaine are like those of Bupivacaine: nausea, constipation, vomiting, and pyrexia. There have been reports of adverse neurologic reactions with the use of local anesthetics, and toxic blood concentrations depress cardiac conductivity and excitability.

    Measured: Post-operative day 0 to clinic follow-up at 2-5 weeks post-operatively

  8. Length of Stay

    Length of hospital stay (days) and length of intensive care unit (ICU) stay will be documented for all patients.

    Measured: From date of hospital admission for surgical procedure until date of discharge from hospital, assessed up to 104 weeks.

  9. Cost-of-Care

    Cost-of-care is an important secondary outcome of this study. The study drugs-Liposomal bupivacaine (Exparel®) and 0.25% bupivacaine hydrochloride (Marcaine®)-are standard of care medications which would be provided to all patients regardless of trial enrollment. The injection volumes of each medication also do not vary between treatment arms. Thus, no difference in cost is incurred for study drugs. Cost-of-care differences arise from equipment costs for ICNB, SAPB, and combination blocks, as well as from billable procedure costs, physician relative value units (RVUs), OR time, and hospital stay time. An activity-based and item-based fee analysis will be performed in combination with LOS and operative time differences between treatment arms to complete a cost analysis as part of this trial.

    Measured: Peri-operative, assessed up to 2 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study startOct 2026 (estimated)
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07254650
Sponsor's protocol ID
STU20251629
Acronym
CALMS-1
Status last verified
Aug 2026
First submitted
4 Nov 2025
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Xu HT, Zimmerman J, Bertoch T, Chen L, Chen PJ, Onel E. Efficacy, safety, and pharmacokinetics of CPL-01, an investigational long-acting ropivacaine, in bunionectomy: Results of a phase 2b study. J Foot Ankle Surg. 2025 Mar-Apr;64(2):150-156. doi: 10.1053/j.jfas.2024.09.007. Epub 2024 Sep 19.

    PubMed 39303759

  • Zhang Y, Xian X, Wang F, Zhou B, Wang Y, Wang P, Li Y, Wu Y. Opioid-Free Anesthesia Improved the Quality of Recovery After Thyroidectomy Through Pre-Emptive and Preventive Analgesia: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 Jun 19;19:5243-5254. doi: 10.2147/DDDT.S520856. eCollection 2025.

    PubMed 40552090

  • Xu HT, Zimmerman J, Bertoch T, Chen L, Chen PJ, Onel E. CPL-01, an investigational long-acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair. Hernia. 2024 Aug;28(4):1345-1354. doi: 10.1007/s10029-024-03047-3. Epub 2024 May 7.

    PubMed 38713429

  • Administration, U. S. F. a. D. (2022). Statistical Review and Evaluation: P211988Orig1s000StatR. (P211988Orig1s000). U.S. Food and Drug Administration Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/211988Orig1s000StatR.pdf?utm_source

  • Lang-Illievich K, Wejbora M, Szilagyi IS, Bornemann-Cimenti H. A novel metric for reporting acute postoperative pain correlates more closely with patient satisfaction. Br J Anaesth. 2020 Jun;124(6):e228-e229. doi: 10.1016/j.bja.2020.02.011. Epub 2020 Mar 19. No abstract available.

    PubMed 32199586

  • Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee GC. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019 May 21:rapm-2019-100531. doi: 10.1136/rapm-2019-100531. Online ahead of print.

    PubMed 31113830

  • Kannampallil T, Galanter WL, Falck S, Gaunt MJ, Gibbons RD, McNutt R, Odwazny R, Schiff G, Vaida AJ, Wilkie DJ, Lambert BL. Characterizing the pain score trajectories of hospitalized adult medical and surgical patients: a retrospective cohort study. Pain. 2016 Dec;157(12):2739-2746. doi: 10.1097/j.pain.0000000000000693.

    PubMed 27548045

  • Ilfeld BM, Malhotra N, Furnish TJ, Donohue MC, Madison SJ. Liposomal bupivacaine as a single-injection peripheral nerve block: a dose-response study. Anesth Analg. 2013 Nov;117(5):1248-56. doi: 10.1213/ANE.0b013e31829cc6ae.

    PubMed 24108252

  • Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.

    PubMed 15733628

  • Musoro JZ, Coens C, Sprangers MAG, Brandberg Y, Groenvold M, Flechtner HH, Cocks K, Velikova G, Dirven L, Greimel E, Singer S, Pogoda K, Gamper EM, Sodergren SC, Eggermont A, Koller M, Reijneveld JC, Taphoorn MJB, King MT, Bottomley A; EORTC Melanoma, Breast, Head and Neck, Genito-urinary, Gynecological, Gastro-intestinal, Brain, Lung and Quality of Life Groups. Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types. Eur J Cancer. 2023 Jul;188:171-182. doi: 10.1016/j.ejca.2023.04.027. Epub 2023 May 7.

    PubMed 37257278

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PubMed 8433390

  • Davidson EM, Barenholz Y, Cohen R, Haroutiunian S, Kagan L, Ginosar Y. High-dose bupivacaine remotely loaded into multivesicular liposomes demonstrates slow drug release without systemic toxic plasma concentrations after subcutaneous administration in humans. Anesth Analg. 2010 Apr 1;110(4):1018-23. doi: 10.1213/ANE.0b013e3181d26d2a.

    PubMed 20357145

  • Yoon SH, Bae J, Yoon S, Na KJ, Lee HJ. Correlation Between Pain Intensity and Quality of Recovery After Video-Assisted Thoracic Surgery for Lung Cancer Resection. J Pain Res. 2023 Oct 2;16:3343-3352. doi: 10.2147/JPR.S426570. eCollection 2023.

    PubMed 37808464

  • van Dijk JF, van Wijck AJ, Kappen TH, Peelen LM, Kalkman CJ, Schuurmans MJ. The effect of a preoperative educational film on patients' postoperative pain in relation to their request for opioids. Pain Manag Nurs. 2015 Apr;16(2):137-45. doi: 10.1016/j.pmn.2014.05.006. Epub 2014 Sep 22.

    PubMed 25246325

  • Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.

    PubMed 22570563

Questions about this trial

What is this clinical trial studying?

A study testing Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block, Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block and Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block in people with Lung Cancer (Diagnosis), run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Inderpal S Sarkaria, MD, MBA (214-645-7700, Inderpal.Sarkaria@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NRS AUC 72 (time frame: Post-operative day 0 to post-operative day 3 (if still present in the hospital)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07254650, which also lists 58 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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