Clinical trial NCT06964347: Combined Local Anesthetic Blockade and Neuromodulation vs Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation: RCT
Official title: A Randomized Clinical Trial Comparing the Analgesic Efficacy of Combined Local Anesthetic Blockade and Neuromodulation (Hybrid Technique) Versus Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amputation
Keywords: peripheral nerve stimulation
neuromodulation
peripheral nerve block
post-amputation pain
below-knee amputation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of two groups: 1) Group Hybrid block 2) Group LA block
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain scores
timeFrame: First 24 postoperative hours
Secondary outcomes:
measure: Analgesic consumption
timeFrame: At 24, 48, and 72 postoperative hours
measure: Quality of recovery (QoR-15)
timeFrame: At postoperative clinic visit (around 1-2 weeks)
measure: Pain scores
timeFrame: At 12 hour time intervals over the 72 hours
measure: Brief Pain Inventory - short form
timeFrame: During the preoperative assessment and at the 3 and 6 months postoperative assessments.
measure: Phantom limb pain
timeFrame: At 1 week, three months, 6 months and 1 year
measure: Adverse events
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Time to ambulation
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Hospital length of stay
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Edmonton
country: Canada
facility: University of Alberta
Study officials:
References: