Pain Management in Response to Exparel vs. Standard Bupivicaine

Pain Clinical Trial

— VATS Exparel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499159
• Other study ID #: 14-1656
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: January 2021
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Liposomal Bupivicaine
266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.
• 0.25% standard bupivicaine
standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.

Locations

Country	Name	City	State
United States	Cardiac, Vascular, and Thoracic Surgery Associates	Falls Church	Virginia
United States	Inova Fairfax Hospital	Falls Church	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	Mednax National Medical Group

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

Debreceni G, Molnár Z, Szélig L, Molnár TF. Continuous epidural or intercostal analgesia following thoracotomy: a prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2003 Oct;47(9):1091-5. — View Citation

Kaiser AM, Zollinger A, De Lorenzi D, Largiadèr F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital Length of Stay	Median length of stay in days until discharge.	From end of procedure until discharge, usually 0-2 days.
Secondary	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
Secondary	Return to Work	Using surveys, patients are asked if they have been able to return to work.	Assessed at 30 days post-procedure
Secondary	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
Secondary	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).