Pain Management in Response to Exparel vs. Standard Bupivicaine

NCT02499159 | Completed Phase 4 Results

• 1 other identifier: 14-1656
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain

Keywords

Exparel; Thoracoscopy; Bupivicaine; Liposomal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Scores on a Analog Pain Scale (7 Days)

  Assessed at day 7 post-procedure

• Scores on an Analog Pain Scale (30 Days)

  Assessed at 30 days post-procedure

• Number of Patients With Paresthesias (Postoperatively at 7 Days)

  Assessed at day 7 post-procedure

• Proportion of Patients With Paresthesias (Postoperatively at 30 Days)

  Assessed at day 30 post-procedure

• Hospital Length of Stay

  From end of procedure until discharge, usually 0-2 days.

Study Arms (2)

Exparel

EXPERIMENTAL

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

0.25% standard bupivicaine

ACTIVE COMPARATOR

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

Interventions

Liposomal Bupivicaine DRUG

266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.

Also known as: Exparel

Exparel

0.25% standard bupivicaine DRUG

standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.

Also known as: Bupivicaine

0.25% standard bupivicaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over 18 years of age
• Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead
• Mednax National Medical Group: collaborator

Study Sites (2)

Cardiac, Vascular, and Thoracic Surgery Associates

Falls Church, Virginia, 22042, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (6)

• 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.

  PMID: 19022040 BACKGROUND

• 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.

  PMID: 19699918 BACKGROUND

• 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.

  PMID: 1914056 BACKGROUND

• 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.

  PMID: 12969101 BACKGROUND

• 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.

  PMID: 9725371 BACKGROUND

• 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.

  PMID: 15166580 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Devon Collins
• Organization: Inova Health System

Devon.Collins@inova.org

703-776-4096

Study Officials

• Sandeep J Khandhar, MD

  Cardiac, Vascular, and Thoracic Surgery Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 16, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 16, 2021
• Results First Posted: September 6, 2019

Record last verified: 2021-01

Locations

US (2)