Phase 4
Completed N=100
Pain Management in Response to Exparel vs. Standard Bupivicaine
Source: ClinicalTrials.gov NCT02499159 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Sep 2019
Primary outcomePrimary: Overall Amounts of Pain Medications Consumed Through Post-operative Day 7 — 1294; 1455.5 tablets
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Amounts of Pain Medications Consumed Through Post-operative Day 7 |
1294; 1455.5 | — |
| SECONDARY Scores on a Analog Pain Scale (7 Days) |
1.5; 1 | — |
| SECONDARY Scores on an Analog Pain Scale (30 Days) |
0; 0 | — |
| SECONDARY Number of Patients With Paresthesias (Postoperatively at 7 Days) |
10; 20 | — |
| SECONDARY Proportion of Patients With Paresthesias (Postoperatively at 30 Days) |
6; 5 | — |
| SECONDARY Hospital Length of Stay |
0; 0 | — |
| SECONDARY Return to Baseline Activity |
40; 47 | — |
| SECONDARY Return to Work |
24; 17 | — |
| SECONDARY Days Until Return to Work |
6.5; 5 | — |
| SECONDARY Overall Hospital Cost |
— | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02499159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.