Liposomal Bupivacaine for Pain Control in Lung Cancer Surgery

(CALMS-1 Trial)

Overseen By Inderpal S Sarkaria, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Pre-operative narcotics

Disqualifiers: Pregnancy, Renal failure, Hepatic failure, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Intra-operative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different methods of delivering pain medication can aid individuals undergoing lung surgery. It tests a long-acting local anesthetic, Liposomal Bupivacaine, to determine if various delivery methods can improve pain control and reduce opioid use post-surgery. Participants will receive the medication through one of three methods: an intercostal nerve block (targeting nerves between the ribs), a serratus anterior plane block (targeting the side of the chest), or a combination of both. The trial aims to identify which method most effectively eases pain and enhances recovery. Individuals planning minimally invasive lung surgery, such as a robotic lobectomy or segmentectomy, may be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques that could improve recovery after lung surgery.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking pre-operative narcotics, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that liposomal bupivacaine is safe for humans. In studies, patients who received a serratus anterior plane block with liposomal bupivacaine experienced effective pain relief for up to three days after surgery, indicating good tolerance. Another study found that when used as an intercostal nerve block, liposomal bupivacaine was safe and as effective as other pain relievers. Additionally, a review of patients who had intercostal blocks with liposomal bupivacaine during chest surgery confirmed its safety for pain control. These findings support the safety of liposomal bupivacaine in various surgical situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for post-surgical pain control in lung cancer, which often rely on systemic opioids, liposomal bupivacaine is a localized option that releases medication slowly over time. Researchers are excited about this treatment because it potentially reduces the need for opioids, minimizing their side effects and addiction risks. Additionally, the use of liposomal bupivacaine in various nerve block techniques, such as the serratus anterior plane block and intercostal nerve block, offers targeted pain relief directly at the surgery site. This method of delivery could lead to more effective and longer-lasting pain control with fewer overall systemic effects.

What evidence suggests that this trial's treatments could be effective for pain control in lung cancer surgery?

Research has shown that using Liposomal Bupivacaine in certain pain relief techniques can reduce pain for up to three days after surgery. In this trial, participants will be randomized into different arms to receive Liposomal Bupivacaine through various methods. One arm will use an intercostal nerve block, which may manage pain more effectively. However, some studies suggest it might not always surpass traditional pain relief methods. Specifically, for intercostal nerve blocks, Liposomal Bupivacaine has improved pain control and reduced the need for opioids. Overall, it offers significant benefits in managing pain after chest surgery. ^{1 3 5 6 7}

Who Is on the Research Team?

Inderpal S Sarkaria, MD, MBA

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adult patients undergoing minimally invasive chest surgery who need pain control. It's not specified who can't join, but typically those with allergies to the anesthetic or health issues that could interfere with the study might be excluded.

Inclusion Criteria

I am scheduled for a specific type of lung surgery using a robot.

I am 18 years old or older.

I can understand and am willing to sign the consent form.

Exclusion Criteria

My kidney function is low, with high creatinine or low filtration rate.

My liver is not working well (high ammonia or severe liver disease).

Vulnerable populations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Liposomal Bupivacaine via intercostal nerve block, serratus anterior plane block, or combination block during surgery

Intra-operative

1 visit (in-person, during surgery)

Post-operative Monitoring

Participants are monitored for pain and opioid use, with pain assessments conducted every 4 hours and daily questionnaires administered

3 days

Continuous monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain interference, quality of life, and adverse events

Up to 365 days

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

What Are the Treatments Tested in This Trial?

Interventions

• Liposomal Bupivacaine

Trial Overview The study tests how well different locations of administering a long-acting local anesthetic (Exparel®) manage post-surgery pain. Patients will receive either an intercostal nerve block, serratus anterior plane block, or both and their pain levels and opioid use are monitored.

How Is the Trial Designed?

Group I: Arm 3 "LipoB-C": Liposomal Bupivacaine via Combination Block Experimental Treatment 1 Intervention

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.

Group II: Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block Experimental Treatment 1 Intervention

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.

Group III: Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

The University of Texas at Dallas

Collaborator

Trials

71

Recruited

108,000+

Simmons Cancer Center

Collaborator

Trials

3

Recruited

80+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39629142/

The Efficacy of Liposomal Bupivacaine in Thoracic Surgery Secondary outcomes included 24-hour postoperative MMEs, postoperative pain score in the first 24 and 48 hours, hospital length of stay (LOS), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07254650

Combination Versus Alone Liposomal Bupivacaine Blocks ... Is pain decreased when local analgesia is provided as a combination of serratus anterior plane block and intercostal nerve block when compared ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S095281802400179X

Combined pectoralis and serratus anterior plane blocks ... Liposomal bupivacaine did not improve OBAS during the initial postoperative three days following minimally invasive thoracic procedures.

4. jtcvs.org jtcvs.org/article/S0022-5223(20)30752-2/pdf

Randomized trial of bupivacaine with epinephrine versus ... Howev- er, length of hospital stay was shorter in the patients who received intercostal liposomal bupivacaine, and more pa- tients were ambulatory 24 hours ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147462/

Comparing Liposomal Bupivacaine and Ropivacaine in ... Ultrasound-guided SAPB with liposomal bupivacaine was effective in relieving postoperative pain for three days after surgery in patients undergoing VATS.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12443838/

Liposomal bupivacaine intercostal nerve block for pain control ... This study aimed to evaluate and compare the analgesic efficacy of liposomal bupivacaine (LB) versus conventional bupivacaine hydrochloride ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/13645706.2024.2440910?af=R

Efficacy of liposomal as compared to standard bupivacaine ... Mostly low-quality evidence shows that liposomal bupivacaine does not offer additional benefits over standard bupivacaine when used for ICB.