AmputationNCT06964347
Combined Local Anesthetic Blockade and Neuromodulation vs Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation: RCT
A study testing Ropivacaine 0.2% + nerve stimulator set and Ropivacaine 0.2% in people with Amputation, run by Stanford University at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Ropivacaine 0.2% + nerve stimulator set and Ropivacaine 0.2%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years of age
- Undergoing below-knee amputation
Who cannot join
- 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.)
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites
University of Iowa
Iowa City, Iowa, 52242
Rakesh Sondekoppam, MD
Mayo Clinic
Jacksonville, Florida, 32224
Hari Kalagara, MD
Stanford University
Stanford, California, 94305
Ban CH Tsui, MD, 650-200-9107, bantsui@stanford.edu
About this study
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
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.
Read the 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.
- Conditions
- Amputation
- Being tested
- Ropivacaine 0.2% + nerve stimulator set, Ropivacaine 0.2%
- Keywords
- peripheral nerve stimulation, neuromodulation, peripheral nerve block, post-amputation pain, below-knee amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% + nerve stimulator setDevice
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).
Ropivacaine 0.2%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Hybrid block | Experimental | Continuous local anesthetic infusion through the nerve block catheter and peripheral nerve stimulation. Receives: Device: Ropivacaine 0.2% + nerve stimulator set |
| Group LA block | Active comparator | Continuous local anesthetic infusion through the nerve block catheter. Receives: Drug: Ropivacaine 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: First 24 postoperative hours
Secondary outcomes (8)
Analgesic consumption
Cumulative rescue and breakthrough analgesic consumption
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: At 1 week, three months, 6 months and 1 year
Adverse events
Block and opioid-related adverse events
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Time to ambulation
Number of post-operative days until ambulation
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Hospital length of stay
Number of post-operative days spent in hospital
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two groups: 1) Group Hybrid block 2) Group LA block
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Ho Ban Tsui, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964347
- Sponsor's protocol ID
- 73646
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06964347
- Acronym / sponsor ID
- 73646
- Conditions
- Amputation
- Keywords
- peripheral nerve stimulation, neuromodulation, peripheral nerve block, post-amputation pain, below-knee amputation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of two groups: 1) Group Hybrid block 2) Group LA block
| Arm | Type | Receives |
|---|---|---|
| Group Hybrid block | Experimental | Device: Ropivacaine 0.2% + nerve stimulator setContinuous local anesthetic infusion through the nerve block catheter and peripheral nerve stimulation. |
| Group LA block | Active comparator | Drug: Ropivacaine 0.2%Continuous local anesthetic infusion through the nerve block catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients at least 18 years of age
- Undergoing below-knee amputation
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.2% + nerve stimulator setPatients 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). | Device | Group Hybrid block |
| Ropivacaine 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. | Drug | Group LA block |
Primary outcome
Pain scores
Time frame: 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)
8 secondary outcomes
Analgesic consumption
Time frame: At 24, 48, and 72 postoperative hours
Quality of recovery (QoR-15)
Time frame: At postoperative clinic visit (around 1-2 weeks)
Pain scores
Time frame: At 12 hour time intervals over the 72 hours
Brief Pain Inventory - short form
Time frame: During the preoperative assessment and at the 3 and 6 months postoperative assessments.
Phantom limb pain
Time frame: At 1 week, three months, 6 months and 1 year
Adverse events
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Time to ambulation
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Hospital length of stay
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.2% + nerve stimulator set and Ropivacaine 0.2% in people with Amputation, run by Stanford University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ban CH Tsui, MD (6502009107, bantsui@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: First 24 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.