Phase 4 N=102 Randomized Treatment

Study of Exparel Versus Epidural for Pain Control After Thoracotomy

Pain Following Thoracotomy Surgery

Bottom Line

View on ClinicalTrials.gov: NCT02178553 ↗

Enrolled (actual)

102

Serious AEs

11.8%

Results posted

Jan 2020

Primary outcome: Primary: Pain Scores With Cough on First Postoperative Day — 6.1; 6.9 units on a scale — p=0.142

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Epidural (Drug); Intercostal Bupivicaine (Exparel) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Oct 2018

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

Summary

Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.

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.

View full record on ClinicalTrials.gov →

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.