Phase 3
Completed N=106
A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
Anesthesia
Source: ClinicalTrials.gov NCT02479763 ↗
Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Patients With Successful Epidural Blocks — 76; 98 percentage of patients
Summary
In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Successful Epidural Blocks |
76; 98 | — |
Eligibility Criteria
Inclusion Criteria
- the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35
Exclusion Criteria
- adults who are unable to give their own consent
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, or International Normalized Ratio ≥ 1.4)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
- allergy to local anesthetic (LA)
- pregnancy
- prior surgery in the thoracic spine
Data sourced from ClinicalTrials.gov (NCT02479763). 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.