Comparing two pain management methods after robotic lung surgery
Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
PHASE4 · The Cooper Health System · NCT03906617
This study is testing which pain relief method works better after robotic lung surgery by comparing a special numbing medicine to a combination of numbing medicine with two other drugs.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The Cooper Health System (other) |
| Locations | 1 site (Camden, New Jersey) |
| Trial ID | NCT03906617 on ClinicalTrials.gov |
What this trial studies
This study evaluates pain relief following robotic lung surgery by comparing two methods of analgesia: liposomal bupivacaine and a combination of bupivacaine with epinephrine and dexamethasone. Participants will be randomly assigned to receive either treatment through intercostal nerve blocks and wound infiltration. The goal is to determine which method provides better pain control in patients undergoing robotic wedge resection or lobectomy for lung masses. This is a Phase 4 interventional study, indicating it is focused on assessing the effectiveness of these treatments in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for robotic wedge resection or lobectomy for lung masses.
Not a fit: Patients with a history of opiate abuse, chronic pain syndrome, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing robotic lung surgery.
How similar studies have performed: While liposomal bupivacaine has been studied in various contexts, this specific comparison with bupivacaine/epinephrine + dexamethasone in robotic lung surgery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * undergoing robotic wedge resection or lobectomy for lung mass(es) Exclusion Criteria: * emergency case * history of opiate abuse * chronic pain syndrome * intravenous drug use * chronic use of oral steroids * pregnancy * imprisonment * body weight lower than 70 kg * liver failure * uninsured patients * non-verbal patients or patients who are unable to rate their pain on a visual analogue pain scale * history of allergic reaction to any of the drugs used in the study: bupivacaine, liposomal bupivacaine, dexamethasone
Where this trial is running
Camden, New Jersey
- Cooper University Hospital — Camden, New Jersey, United States (RECRUITING)
Study contacts
- Study coordinator: Noud van Helmond, MD
- Email: vanhelmond-noud@cooperhealth.edu
- Phone: 856-968-7336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Robotic Lung Surgery