Is continuous perineural stump infusion of bupivacaine effective on acute and chronic postoperative stump pain? Could it reduce phantom pain after major lower limb amputation?

Abstract

Background. Chronic pain as the result of long-term peripheral arterial disease and critical limb ischemia is difficult to manage and needs a multidisciplinary approach (pharmacological, psychological and functional) especially when the patient undergoes a lower limb amputation. Amputees show high rates of acute postoperative pain and chronic phantom limb pain in which there are few satisfactory available treatments. Nevertheless, it has been suggested for many years that continuous regional infusion of local anesthetic during immediate postoperative period is an effective and safe way of reducing these complications, morphine consumption and opioids-related adverse effects. However, data is conflicting as to its efficacy for both short-and log-term outcomes. Objective. The purpose of this study is to investigate whether a continuous postoperative perineural infusion system with bupivacaine is effective in reduction of postoperative acute pain and morphine intake during the first 72 hours post-amputation period, and also if it has some benefice in reducing the incidence of long-term phantom limb pain and stump pain Design. A randomized, controlled, double-blinded, multicentric clinical trial will be performed between September 2016 and May 2020 in Hospital Universitari Dr. Josep Trueta of Girona and Hospital Universitari Germans Trias I Pujol of Badalona. Patients and methods. Patients aged up to 18 who need major lower limb amputation for irreversible critical limb ischemia as a consequence of vascular disease. Patients will be divided into two groups: one group will receive a continuous local anesthetic wound infusion treatment. The other group will receive a continuous physiologic serum infusion. All patients will be connected to intravenous morphine pump (patient controlled analgesic system) and standard treatment of postoperative pain