Evaluating Continuous Perineural Methylene Blue and Bupivacaine Infusion to Manage Pain in Lower Limb Amputation Surgery

What this Trial Is About

Researchers are evaluating the pain relief effect of continuous perineural infusion of methylene blue combined with bupivacaine compared to bupivacaine alone in patients undergoing lower limb amputation surgery. The study aims to reduce acute postoperative pain and prevent chronic phantom limb pain, which is a challenging condition to treat. Methylene blue is known for its pain-blocking, antioxidant, and anti-inflammatory properties and may help maintain local anesthesia for about 20 days. Participants will be randomly assigned to one of two groups. One group receives a bolus dose of methylene blue plus bupivacaine before wound closure, followed by a continuous perineural infusion of methylene blue with bupivacaine at a controlled rate for 72 hours after surgery. The other group receives a bolus dose of normal saline plus bupivacaine, then continuous bupivacaine infusion alone at the same rate and duration. During the study, participants will be monitored for their level of postoperative pain three days after surgery and assessed for the occurrence of phantom limb pain nine months later. The study includes detailed pain evaluations to measure the effectiveness of the treatment and its preventive role. Safety and recovery will be observed throughout the follow-up period, with the study concluding in November 2027.

Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery