Phase 4
Completed N=102
Study of Exparel Versus Epidural for Pain Control After Thoracotomy
Pain Following Thoracotomy Surgery
Source: ClinicalTrials.gov NCT02178553 ↗
Enrolled (actual)
102
Serious AEs
11.8%
Results posted
Jan 2020
Primary outcomePrimary: Pain Scores With Cough on First Postoperative Day — 6.1; 6.9 units on a scale — p=0.142
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores With Cough on First Postoperative Day |
6.1; 6.9 | 0.142 |
| PRIMARY Pain Scores With Cough on the Second Postoperative Day |
5.2; 6.0 | 0.101 |
| SECONDARY Pain Scores at Rest in the Morning on the First Postoperative Day |
2.9; 4.0 | 0.014 sig |
| SECONDARY Pain Scores at Rest on the Second Postoperative Day |
2.8; 3.2 | 0.375 |
Eligibility Criteria
Inclusion Criteria
- Age 18 years and older
- Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).
Exclusion Criteria
- Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;
- Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution);
- Daily opioid therapy;
- Current gabapentin or pregabalin therapy;
- Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement;
- Severe psychological disorders or inability to understand the study protocol; -Prisoners or other institutionalized individuals;
- Severe hepatic, renal or cardiovascular disorders.
- Women who are pregnant will not be included in this study.
Data sourced from ClinicalTrials.gov (NCT02178553). 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.