WAFER Trial: A randomized controlled trial comparing Wide-awake Local Anesthesia No Tourniquet (WALANT) to General and Regional Anesthesia with tourniquet for Flexor Tendon Repair.

Abstract

Wide-awake local anesthesia no tourniquet (WALANT) is increasingly used for flexor tendon repair, but comparative data versus general/regional anesthesia(GA/RA) are limited. The aims of the WAFER trial were to generate high quality comparative data on WALANT versus GA/RA for flexor tendon repair and assess the feasibility of performing a large multicenter trial of this nature. WAFER was a multicenter, assessor-blinded, parallel-group RCT with embedded qualitative and health economic components across four major hand units. Patients were randomized on a 1:1 basis to have flexor tendon repair under GA/RA or WALANT. The primary feasibility outcomes were recruitment, retention and trial acceptability in addition to clinical outcomes which included range of motion (Total-active-motion score), grip/pinch strength, finger circumference, complications and patient reported outcome measures(PROMS) (Michigan-Hand-Questionnaire, EQ-5D-5L). Qualitative interviews were conducted with clinicians and participants to assess acceptability and equipoise. Economic analyses summarized intra-operative costs and impact on productivity. The primary analysis set was per-protocol. Sixty participants were randomized across all sites (30 WALANT; 30 GA/RA); 56 were analyzed per-protocol. At 6 months, mean TAM score(SE) for GA/RA was 67.6(5.6) vs 60.3(6.3) in the WALANT group. Tendon rupture was reported in two patients in the GA/RA group and three in the WALANT group. PROMs improved over time in both groups, patients in the WALANT arm reported consistently higher MHQ scores across domains. Participants in WALANT arm returned to work earlier than participants in GA/RA arm (mean 3.0 vs 6.7weeks). Intra-operative costs were lower with WALANT by 54% (-£398, 95% CI -£509 to -£287). A pragmatic comparison of WALANT versus GA/RA with tourniquet for primary flexor tendon repair is deliverable and safe. Inter-arm clinical differences were small; however, WALANT showed lower intra-operative costs and a signal for earlier return to work.