Pain Management in Response to Exparel vs. Standard Bupivicaine
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/15/2018 |
| Start Date: | December 2014 |
| End Date: | June 2018 |
A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy
This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on
decreasing the amount of consumed pain medications.
Patients will be randomly selected to received either Exparel or standard bupivicaine
injection during surgery. Patients will be followed up to assess pain levels using a visual
pain scale, and to assess how much pain medication was consumed.
decreasing the amount of consumed pain medications.
Patients will be randomly selected to received either Exparel or standard bupivicaine
injection during surgery. Patients will be followed up to assess pain levels using a visual
pain scale, and to assess how much pain medication was consumed.
Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia
for up to 72 hours post injection.
It is the investigators' aim to follow their prior study with a randomized trial to compare
local infiltration of liposomal bupivacaine at the conclusion of each procedure with
injections of standard .25% bupivacaine.
Patients in group A will receive, at the end of the surgical procedure, injections of
liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the
thoracoscopic port incision sites and around the intercostal nerves serving that space.
Patients in group B will receive, at the end of the surgical procedure, injections of
standard .25% bupivacaine into the thoracoscopic port incision sites and around the
intercostal nerves serving that space.
for up to 72 hours post injection.
It is the investigators' aim to follow their prior study with a randomized trial to compare
local infiltration of liposomal bupivacaine at the conclusion of each procedure with
injections of standard .25% bupivacaine.
Patients in group A will receive, at the end of the surgical procedure, injections of
liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the
thoracoscopic port incision sites and around the intercostal nerves serving that space.
Patients in group B will receive, at the end of the surgical procedure, injections of
standard .25% bupivacaine into the thoracoscopic port incision sites and around the
intercostal nerves serving that space.
Inclusion Criteria:
- All patients over 18 years of age
- Isolated thoracoscopic procedure for therapeutic or diagnostic purposes
Exclusion Criteria:
- Previous ipsilateral thoracic surgery
- Need for operative pleurectomy or pleurodesis
- Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs
(NSAIDs), sedatives, or hypnotics
- Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or
acetaminophen
- Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
- Renal dysfunction (eGFR < 60ml/min/1.73m2)
- History of peptic ulcerative disease
- Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen
supplementation
- Inability to consent
- Pregnancy
- Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy
- Patient is discharged from the hospital with a chest tube in place
- Patient fails to comply with post-operative instructions
We found this trial at
2
sites
3300 Gallows Road
Falls Church, Virginia 22042
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Sandeep J Khandhar, MD
Phone: 703-280-5858
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, Virginia 22042
Principal Investigator: Sandeep J Khandhar, MD
Phone: 703-280-5858
Click here to add this to my saved trials