Local versus general anesthesia for stapes surgery: a prospective study of comfort and results on 100 ears.

AIMS: To demonstrate the non-inferiority of perioperative comfort in patients undergoing otosclerosis surgery under local anesthesia versus general anesthesia and to compare audiometric results, quality of life and complications.

MATERIALS AND

METHODS

A prospective non-interventional study was performed. Patients undergoing otosclerosis surgery between January 2019 and March 2021 at the University Hospital of Rennes were included consecutively. Perioperative comfort of LA versus GA (at ward admission, surgery, recovery and 48 h following surgery) was measured on a visual analogue scale at 10 days postoperatively and quality of life by the Glasgow Benefit Inventory at 3 months. Complications and audiometric results were also assessed. To demonstrate the non-inferiority of LA versus GA with a margin of 1.5 points on the comfort VAS, a power of 80% and a first-order risk of 5, 100 patients were included and statistical analyses were performed in accordance with CONSORT2010 statement.

RESULTS

One hundred ears were analyzed, 46% operated under local anesthesia and 54% under general anesthesia. The two groups were similar in terms of demographic and pathological characteristics. Local anesthesia was non-inferior to general anesthesia in terms of comfort with a comfort VAS of 8.74 ± 1.55 and 9.08 ± 0.93 respectively (p < 0.0001). There were no significant differences in rates of complications, audiometric results and quality of life between local and general anesthesia.

CONCLUSION

Local anesthesia is non-inferior to general anesthesia in terms of perioperative patient comfort with similar audiometric results, postoperative quality of life and complication rates.