BridgeMD
Compares treatment options for Pain, Postoperative
Official title Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
ClinicalTrials.gov ID: NCT03737292
What this study is testing
What is Exparel?
Exparel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pain, postoperative.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries. The specific aim of this study is to evaluate plasma concentration of bupivacaine after intraoperative intercostal injections of 266 mg of liposomal bupivacaine and compare it to plasma concentrations of bupivacaine after intercostal injections of 2mg/kg of 0.5% plain Bupivacaine with maximal dose of 30 ml or 150 mg.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including but not limited to:
- VATS wedge resection /segmentectomy
- VATS lobectomy.
- Robot assisted thoracoscopic wedge resection/segmentectomy.
- Robot assisted thoracoscopic lobectomy procedures.
You likely can't join if
- Patients under18 years of age
- Patients weighing less than 48 kg
- Pregnant and lactating females will be excluded from the trial
- Patients preoperatively taking narcotics for chronic pain in proximity to surgical site
- Patients with previous ipsilateral thoracic surgery
- Patients undergoing pleurectomy/mechanical pleurodesis.
See the full eligibility criteria
- 1\. Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including but not limited to:
- VATS wedge resection /segmentectomy
- VATS lobectomy.
- Robot assisted thoracoscopic wedge resection/segmentectomy.
- Robot assisted thoracoscopic lobectomy procedures.
- Patients under18 years of age
- Patients weighing less than 48 kg
- Pregnant and lactating females will be excluded from the trial
- Patients preoperatively taking narcotics for chronic pain in proximity to surgical site
- Patients with previous ipsilateral thoracic surgery
- Patients undergoing pleurectomy/mechanical pleurodesis.
- Patients with high likelihood of conversion from thoracoscopic procedure to open thoracotomy as determined by an operating surgeon
- Patients with pre-existing painful conditions (CRIPS, fibromyalgia, neuropathy)
- Patients unable to reliably communicate pain scores such as patients with dementia, alterations in mental status
- Patients with hypersensitivity to local anesthetics and pain medications used in the study
- Patients with previous thoracic spine surgeries
- Patients with increased creatinine (over 1.5mg/dl)
- Patients with liver dysfunction
- Non-English speaking patients
The study team makes the final eligibility decision.
Where it's taking place
- Hershey, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hershey, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.