Pain Management in Response to Exparel vs. Standard Bupivicaine

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Liposomal Bupivicaine; Drug: 0.25% standard bupivicaine

• Registration Number: NCT02499159
• Lead Sponsor: Inova Health Care Services

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-16
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2019-08-13
• Results First Submitted QC: 2019-08-13
• Results First Posted: 2019-09-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exparel	Liposomal Bupivicaine	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.
0.25% standard bupivicaine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Paresthesias (Postoperatively at 7 Days)	Assessed at day 7 post-procedure	Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.
Scores on a Analog Pain Scale (7 Days)	Assessed at day 7 post-procedure	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.
Return to Baseline Activity	Assessed at 30 days post-procedure	Using surveys, patients are asked if they have been able to return to baseline activity levels.
Return to Work	Assessed at 30 days post-procedure	Using surveys, patients are asked if they have been able to return to work.
Days Until Return to Work	Assessed at 30 days post-procedure	Using surveys, the number of days to return to work was assessed for patients who were able to return to work.
Proportion of Patients With Paresthesias (Postoperatively at 30 Days)	Assessed at day 30 post-procedure	Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves
Hospital Length of Stay	From end of procedure until discharge, usually 0-2 days.	Median length of stay in days until discharge.
Scores on an Analog Pain Scale (30 Days)	Assessed at 30 days post-procedure	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.
Overall Hospital Cost	Total cost assessed from patient registration until discharge to home (usually 0-2 days).	Overall hospital cost of patient procedure and stay will be assessed.

Trial Locations

Locations (2)

Cardiac, Vascular, and Thoracic Surgery Associates; 🇺🇸 Falls Church, Virginia, United States

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States