Amputation
Conditions
Keywords
peripheral nerve stimulation, neuromodulation, peripheral nerve block, post-amputation pain, below-knee amputation
Brief summary
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.
Detailed description
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.
Interventions
DEVICERopivacaine 0.2% + nerve stimulator set
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).
DRUGRopivacaine 0.2%
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Study team members collecting the data and participating subjects will be blinded to group allocation.
Intervention model description
Comparison of two groups: 1) Group Hybrid block 2) Group LA block
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years of age * Undergoing below-knee amputation
Exclusion criteria
* Chronic opioid use (daily use within the two weeks before surgery and duration of use of more than four weeks of \> 30 mg of oxycodone per day or \> 50 of morphine milligrams per day) * Neuromuscular deficit of the target nerve(s) * Compromised immune system or concurrent risk of infection based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection). * Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or another implantable neurostimulator whose stimulus current pathway may overlap * History of bleeding disorder or chronic antiplatelet or anticoagulation therapies (other than aspirin) that require to be restarted within the first three postoperative days * Allergy to study medications or devices (including occlusive dressings, bandages, tape, etc.) * Incarceration * Pregnancy * Chronic pain for more than three months of any severity in an anatomic location other than the surgical site * Anxiety disorder * History of substance abuse * Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | First 24 postoperative hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery (QoR-15) | At postoperative clinic visit (around 1-2 weeks) | 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. |
| Pain scores | At 12 hour time intervals over the 72 hours | Static and dynamic pain scores (11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain) |
| Brief Pain Inventory - short form | During the preoperative assessment and at the 3 and 6 months postoperative assessments. | 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. |
| Analgesic consumption | At 24, 48, and 72 postoperative hours | Cumulative rescue and breakthrough analgesic consumption |
| Adverse events | Duration of postoperative recovery (typically 1-2 weeks) | Block and opioid-related adverse events |
| Time to ambulation | Duration of postoperative recovery (typically 1-2 weeks) | Number of post-operative days until ambulation |
| Hospital length of stay | Duration of postoperative recovery (typically 1-2 weeks) | Number of post-operative days spent in hospital |
| Phantom limb pain | At 1 week, three months, 6 months and 1 year | The incidence of phantom limb and residual limb pain in both groups |
Countries
Canada, United States
Contacts
Primary ContactBan CH Tsui, MD
Backup ContactKsenia (kasimova), MD
Outcome results
None listed