Pain Management in Response to Exparel vs. Standard Bupivicaine (VATS Exparel)

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Liposomal Bupivicaine; Drug: 0.25% standard bupivicaine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Falls Church, Virginia, United States, 22042
      • Cardiac, Vascular, and Thoracic Surgery Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exparel; Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.	Drug: Liposomal Bupivicaine; 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.; Other Names: Exparel
Active Comparator: 0.25% standard bupivicaine; Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.	Drug: 0.25% standard bupivicaine; standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.; Other Names: Bupivicaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Amounts of Pain Medications Consumed Through Post-operative Day 7	Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.	Assessed daily for 7 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on a Analog Pain Scale (7 Days)	Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.	Assessed at day 7 post-procedure
Scores on an Analog Pain Scale (30 Days)	Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.	Assessed at 30 days post-procedure
Number of Patients With Paresthesias (Postoperatively at 7 Days)	Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.	Assessed at day 7 post-procedure
Proportion of Patients With Paresthesias (Postoperatively at 30 Days)	Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves	Assessed at day 30 post-procedure
Hospital Length of Stay	Median length of stay in days until discharge.	From end of procedure until discharge, usually 0-2 days.
Return to Baseline Activity	Using surveys, patients are asked if they have been able to return to baseline activity levels.	Assessed at 30 days post-procedure
Return to Work	Using surveys, patients are asked if they have been able to return to work.	Assessed at 30 days post-procedure
Days Until Return to Work	Using surveys, the number of days to return to work was assessed for patients who were able to return to work.	Assessed at 30 days post-procedure
Overall Hospital Cost	Overall hospital cost of patient procedure and stay will be assessed.	Total cost assessed from patient registration until discharge to home (usually 0-2 days).

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: Mednax National Medical Group
• Investigators: Principal Investigator: Sandeep J Khandhar, MD, Cardiac, Vascular, and Thoracic Surgery Associates

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Thoracoscopy; Liposomal; Exparel; Bupivicaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 14-1656