Combined Local Anesthetic Blockade and Neuromodulation vs Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation: RCT

Not Applicable

Not yet recruiting

• Conditions: Amputation
• Interventions: Device: Ropivacaine 0.2% + nerve stimulator set; Drug: Ropivacaine 0.2%

• Registration Number: NCT06964347
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2024-01-09
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Study Start: 2025-12
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Hybrid block	Ropivacaine 0.2% + nerve stimulator set	Continuous local anesthetic infusion through the nerve block catheter and peripheral nerve stimulation.
Group LA block	Ropivacaine 0.2%	Continuous local anesthetic infusion through the nerve block catheter.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Analgesic consumption	At 24, 48, and 72 postoperative hours	Cumulative rescue and breakthrough analgesic consumption
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.
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
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

Trial Locations

Locations (4)

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