Pain Management in Response to Exparel vs. Standard Bupivicaine

Condition(s) targeted: Pain

Intervention: Liposomal Bupivicaine (Drug); 0.25% standard bupivicaine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Inova Health Care Services

Official(s) and/or principal investigator(s):
Sandeep J Khandhar, MD, Principal Investigator, Affiliation: Cardiac, Vascular, and Thoracic Surgery Associates

Overall contact:
Sandeep J Khandhar, MD, Phone: 703-280-5858, Email: sandeep.khandhar@gmail.com

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.

Official title: A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Overall Amounts of Pain Medications Consumed through Post-operative Day 7

Secondary outcome:

Analog Pain Scores

Incidence of Paresthesias

Hospital Length of Stay

Return to Baseline Activity

Return to Work

Overall Hospital Cost

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Sandeep J Khandhar, MD, Phone: 703-280-5858, Email: sandeep.khandhar@gmail.com

Cardiac, Vascular, and Thoracic Surgery Associates, Falls Church, Virginia 22042, United States; Recruiting
Sandeep J Khandhar, MD, Phone: 703-280-5858, Email: sandeep.khandhar@gmail.com
Chrstiana Powers, NP, Phone: 7032805858, Email: cpowers@cvtsa.com
Sandeep J Khandhar, MD, Principal Investigator

Inova Fairfax Hospital, Falls Church, Virginia 22042, United States; Recruiting
Sandeep J Khandhar, MD, Phone: 703-280-5858, Email: sandeep.khandhar@gmail.com
Jeffrey M Wright, MPH, Phone: 703-776-3018, Email: jeffrey.wright@inova.org
Sandeep J Khandhar, MD, Principal Investigator

Starting date: December 2014
Last updated: August 4, 2015