Clinical trial NCT02499159: Pain Management in Response to Exparel vs. Standard Bupivicaine
Official title: A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Exparel
Thoracoscopy
Bupivicaine
Liposomal
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: Mednax National Medical Group
First posted: 2015-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Amounts of Pain Medications Consumed Through Post-operative Day 7
timeFrame: Assessed daily for 7 days post-procedure
Secondary outcomes:
measure: Scores on a Analog Pain Scale (7 Days)
timeFrame: Assessed at day 7 post-procedure
measure: Scores on an Analog Pain Scale (30 Days)
timeFrame: Assessed at 30 days post-procedure
measure: Number of Patients With Paresthesias (Postoperatively at 7 Days)
timeFrame: Assessed at day 7 post-procedure
measure: Proportion of Patients With Paresthesias (Postoperatively at 30 Days)
timeFrame: Assessed at day 30 post-procedure
measure: Hospital Length of Stay
timeFrame: From end of procedure until discharge, usually 0-2 days.
measure: Return to Baseline Activity
timeFrame: Assessed at 30 days post-procedure
measure: Return to Work
timeFrame: Assessed at 30 days post-procedure
measure: Days Until Return to Work
timeFrame: Assessed at 30 days post-procedure
measure: Overall Hospital Cost
timeFrame: Total cost assessed from patient registration until discharge to home (usually 0-2 days).
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Cardiac, Vascular, and Thoracic Surgery Associates
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Cardiac, Vascular, and Thoracic Surgery Associates
name: Sandeep J Khandhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.
citation: Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139.
citation: Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. doi: 10.1007/BF03008451.
citation: Debreceni G, Molnar Z, Szelig L, Molnar TF. Continuous epidural or intercostal analgesia following thoracotomy: a prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2003 Oct;47(9):1091-5. doi: 10.1034/j.1399-6576.2003.00208.x.
citation: Kaiser AM, Zollinger A, De Lorenzi D, Largiader F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. doi: 10.1016/s0003-4975(98)00448-2.
citation: American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available.