RESUMEN
BACKGROUND: The traditional loss-of-resistance (LOR) technique for thoracic epidural catheter placement can be associated with a high primary failure rate. In this study, we compared the traditional LOR technique and dynamic pressure-sensing (DPS) technology for primary success rate and secondary outcomes pertinent to identifying the thoracic epidural space. METHODS: This pragmatic, randomized, patient- and assessor-blinded superiority trial enrolled patients ages 18 to 75 years, scheduled for major thoracic or abdominal surgeries at a tertiary care teaching hospital. Anesthesiology trainees (residents and fellows) placed thoracic epidural catheters under faculty supervision and rescue. The primary outcome was the success rate of thoracic epidural catheter placement, evaluated by the loss of cold sensation in the thoracic dermatomes 20 minutes after injecting the epidural test dose. Secondary outcomes included procedural time, ease of catheter placement, the presence of a positive falling meniscus sign, early hemodynamic changes, and unintended dural punctures. Additionally, we explored outcomes that included number of attempts, needle depth to epidural space, need for faculty to rescue the procedure from the trainee, patient-rated procedural discomfort, pain at the epidural insertion site, postoperative pain scores, and opioid consumption over 48 hours. RESULTS: Between March 2019 and June 2020, 133 patients were enrolled; 117 were included in the final analysis (n = 57 for the LOR group; n = 60 for the DPS group). The primary success rate of epidural catheter placement was 91.2% (52 of 57) in the LOR group and 96.7% (58 of 60) in the DPS group (95% confidence interval [CI] of difference in proportions: -0.054 [-0.14 to 0.03]; P = .264). No difference was observed in procedural time between the 2 groups (median interquartile range [IQR] in minutes: LOR 5.0 [7.0], DPS 5.5 [7.0]; P = .982). The number of patients with epidural analgesia onset at 10 minutes was 49.1% (28 of 57) in the LOR group compared to 31.7% (19 of 60) in the DPS group ( P = .062). There were 2 cases of unintended dural punctures in each group. Other secondary or exploratory outcomes were not significantly different between the groups. CONCLUSIONS: Our trial did not establish the superiority of the DPS technique over the traditional LOR method for identifying the thoracic epidural space ( Clinicaltrials.gov identifier: NCT03826186).
