This multi-site clinical trial aims to assess the efficacy and safety of combining peripheral nerve stimulation with local anesthetic nerve blockade compared to the standard of care, i.e., local anesthetic blockade only using safe stimulation parameters in a condition associated with high postoperative pain state, i.e. a patient undergoing lower limb amputation.
The primary aim of this pilot trial is to evaluate the feasibility, safety, and analgesic efficacy of the hybrid technique (combined PNS and LA-based PNB) compared to that of PNB during the hospital course in patients undergoing below-knee amputations. The secondary aims are to estimate analgesia and opioid-sparing effects at later timepoints of 3, 6, and 12 months following the surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Patients will receive a continuous local anesthetic (LA) infusion through the popliteal sciatic nerve block catheter using an infusion of ropivacaine 0.2% at a rate of 8-12 ml/h for at least 3 postoperative days. In addition, patients will receive a low-frequency peripheral nerve stimulation (PNS) via a nerve stimulator set to the pre-determined setting of adequate clinical response (determined in the preoperative area).
Patients will receive a continuous local anesthetic infusion through the popliteal sciatic nerve block catheter using an infusion of ropivacaine 0.2% at a rate of 8-12 ml/h for at least 3 postoperative days. In addition, patients will have an inactive PNS button for the purposes of blinding.
Stanford University
Stanford, California, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Iowa
Iowa City, Iowa, United States
University of Alberta
Edmonton, Canada
Pain scores
Decrease in the proportional incidence of severe or intolerable pain scores (11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain)
Time frame: First 24 postoperative hours
Analgesic consumption
Cumulative rescue and breakthrough analgesic consumption
Time frame: At 24, 48, and 72 postoperative hours
Quality of recovery (QoR-15)
Survey based on patient-reported outcomes. There are 15 questions based on a scale of 0-10, 0 signifying the worst outcome, 10 signifying the best, for a score range of 0-150.
Time frame: At postoperative clinic visit (around 1-2 weeks)
Pain scores
Static and dynamic pain scores (11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain)
Time frame: At 12 hour time intervals over the 72 hours
Brief Pain Inventory - short form
A self-reported scale that assesses both the severity of pain and impact of pain on daily functioning, each question assessed on an 11-point scale, where 0 represents the best outcome and 10 - the worst outcome. The score range is 0-110.
Time frame: During the preoperative assessment and at the 3 and 6 months postoperative assessments.
Phantom limb pain
The incidence of phantom limb and residual limb pain in both groups
Time frame: At 1 week, three months, 6 months and 1 year
Adverse events
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Block and opioid-related adverse events
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Time to ambulation
Number of post-operative days until ambulation
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Hospital length of stay
Number of post-operative days spent in hospital
Time frame: Duration of postoperative recovery (typically 1-2 weeks)