CLINICAL TRIAL

Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone for Robotic Lung Surgery

Recruiting · 18+ · All Sexes · Camden, NJ

Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine

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About the trial for Robotic Lung Surgery

Treatment Groups

This trial involves 2 different treatments. Intercostal Nerve Block And Wound Infiltration With Bupivacaine/epinephrine + Dexamethasone is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Intercostal nerve block and wound infiltration with liposomal bupivacaine
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
undergoing robotic wedge resection or lobectomy for lung mass(es)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 hours post-surgery
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours post-surgery
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 hours post-surgery.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone will improve 1 primary outcome in patients with Robotic Lung Surgery. Measurement will happen over the course of 24 hours post-surgery.

Visual Analogue Scale pain scores
24 HOURS POST-SURGERY
Visual Analogue Scale (VAS) pain score will be assessed for non-inferiority of bupivacaine/epinephrine +dexamethasone vs. liposomal bupivacaine. A non-inferiority margin of 2 points on the VAS scale will be considered non-inferior.
24 HOURS POST-SURGERY

Who is running the study

Principal Investigator
K. G. M.
Prof. Kingsuk Ganguly M.D., Assistant Professor of Anesthesiology
The Cooper Health System

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for robotic lung surgery?

Robotic surgery offers many advantages compared with traditional open procedures, but is not widely used to date. Many types of pulmonary resections can be completed laparoscopically, for example lobectomy(?) and pneumonectomy. For pneumonectomy, VATS is appropriate. For lobectomy(?), VATS is less advantageous because of cost and operative time. It would appear to offer advantages with limited and selected cases, such as pneumonectomy, and in a highly selected patient group.

Anonymous Patient Answer

What are the signs of robotic lung surgery?

Robotic lung surgery involves several potential risks, including a large learning curve for surgeons unfamiliar with robotic methods of lung surgery and the need to learn surgical techniques in a foreign environment. A careful history and an examination for clinical signs of lung cancer is essential. The current guidelines to screen patients in the United States should be adapted to robotic lung surgery.

Anonymous Patient Answer

What is robotic lung surgery?

Robotic systems simplify and reduce costs, as well as reducing manual effort, in any procedure that is laparoscopic-based. For many indications robotics is as effective or possibly better than laparoscopy.

Anonymous Patient Answer

How many people get robotic lung surgery a year in the United States?

Few surgeons are performing RLS or are attempting RLS at all. These data have implications for the utilization of a system where the surgeon utilizes telemedicine to consult with a general surgeon to assess surgery eligibility and a general anaesthesia provider to perform a consultation with the patient to determine the indication for RLS. Additionally, we found a potential avenue for future training programs to assess the learning phase of robotic lung surgery to determine the best method of delivering robotic lung surgery training in the United States.

Anonymous Patient Answer

Can robotic lung surgery be cured?

Laparoscopic pneumonectomy after a prior failed open procedure is a real option in selected patients, but surgical mortality is not decreased compared to that observed after an open pulmonary wedge resection with bilateral pulmonary artery grafting during the initial operation. The robotic approach can offer a significant improvement in surgeon exposure and mobility, giving the best conditions to operate on a very elderly frail patient population.

Anonymous Patient Answer

What causes robotic lung surgery?

The development of robotic technology may assist in reducing the risk for complications caused by open lung surgery (lung cancer and pulmonary metastasectomy), but it will not eliminate them. The increased risk for postoperative complications requires careful consideration. The study presented here can help surgeons to select the most appropriate minimally invasive surgical procedure by choosing the most appropriate implantable device according to their specific pathologies.

Anonymous Patient Answer

What is the primary cause of robotic lung surgery?

Results from a recent clinical trial revealed that a significant percentage of robotic lung resection had to be performed for pathologic entities other than SIR. The most common causes were tumors and infection. Further studies are needed to identify and prevent problems associated with robotic lung surgery.

Anonymous Patient Answer

Is intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone safe for people?

In this pilot, large institutional, multi-institutional trial, wound infiltration with 0.25% bupivacaine-epinephrine solution mixed with 20 mg dexamethasone resulted in similar pain control without increased complication rates, and may represent a favorable alternative for analgesia and wound infiltration in people undergoing minimally invasive lung surgery.

Anonymous Patient Answer

Have there been any new discoveries for treating robotic lung surgery?

Robotic lung surgery enables minimally invasive, low-level anesthesia and an easier thoracoscopy and VATS approach for surgical lung cancer. The robotic approach will enable patients of low economic status and will lead to improving their quality of life after a surgery.

Anonymous Patient Answer

Who should consider clinical trials for robotic lung surgery?

Lung surgery can be successfully performed using a robot. However, surgeons have a number of variables that may make it difficult for them to accurately decide whether a patient should participate in a clinical trial.

Anonymous Patient Answer

Is intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone typically used in combination with any other treatments?

The IONB was found to be one of the most effective single-bundle block techniques in the present study, especially for alleviating pain and promoting recovery of normal pulmonary function, with no negative clinical effect upon a well-managed patient population. Based upon our findings, we consider the IONB to be useful to complement other regional anesthesia techniques.

Anonymous Patient Answer
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