Pain Management in Response to Exparel vs. Standard Bupivicaine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Liposomal Bupivicaine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

0.25% standard bupivicaine

Intervention Type DRUG

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

Interventions

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Liposomal Bupivicaine

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

Intervention Type DRUG

0.25% standard bupivicaine

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

Intervention Type DRUG

Other Intervention Names

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Exparel Bupivicaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No