Rotator Cuff InjuriesNCT06818708
Feasibility of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery
A study testing Experimental Treatment in people with Rotator Cuff Injuries and Shoulder Disease, run by University of California, San Diego at 1 site in United States.
Trial summary
Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries, Shoulder Disease, Hallux Valgus
- What is being tested?
- Experimental Treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2025to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult participants of at least 18 years of age
- Undergoing a rotator cuff repair, total shoulder arthroplasty, ankle arthroplasty/arthrodesis, or foot surgery anticipated to result in moderate-to-severe pain for at least one week
- Planned single-injection peripheral nerve block(s)
- An Android or Apple smartphone able to download the Gate Keeper controller app
Who cannot join
- Chronic opioid or tramadol use (daily within prior 2 weeks and duration > 4 weeks)
- Neuro-muscular deficit of the surgical limb
- Compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk of infection
- Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap
- History of bleeding disorder
- Antiplatelet or anticoagulation therapies other than aspirin
Show all 16Show fewer
- Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
- Incarceration
- Pregnancy
- Moderate pain (NRS > 3) in an anatomic location other than the surgical site
- Anxiety disorder
- History of substance misuse
- Inability to communicate with the investigators
- Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
- Allergy to amide local anesthetics
- Morbid obesity (body mass index > 40 kg/m2)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92037
About this study
Official title: A Randomized, Single-Blinded, Sham-Controlled Study Evaluating the Efficacy and Safety of RELAY, a Device Enabling Both Local Anesthetic Delivery and Neuromodulation Following Shoulder or Foot Surgery: Single Arm Training Run-In Phase
Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to prepare for a randomized clinical trial investigating the use of the RELAY device to provide postoperative analgesia.
This feasibility study will be a series of participants all receiving both local anesthetic and electric current via a single device (RELAY, Gate Science, Moultonborough, New Hampshire). The purpose will be to optimize the insertion approach and stimulation administration during the first 7 days following foot and shoulder surgery as well as training the clinical investigators.
Read the detailed description
Specific Aim: To determine the feasibility and optimize the protocol for the RELAY device following foot and shoulder surgery to prepare for the subsequent randomized, controlled pilot study.
For individuals of childbearing potential, a sample of urine will be collected before any study interventions to confirm a non-pregnant state (this is standard procedure for all surgical patients). The RELAY device combines a catheter-over-needle to permit ultrasound-guided percutaneous insertion with the tip adjacent to a peripheral nerve or plexus, followed by needle removal which leaves the catheter in situ to deliver a bolus of local anesthetic (if desired) and subsequent perineural local anesthetic infusion (if desired). The catheter also has 3 integrated electrodes to enable neuromodulation using the integrated pulse generator and battery.
Participants will have standard external monitors placed and oxygen delivered by facemask or nasal cannula. The peripheral nerve block site(s) will be cleansed with chlorhexidine gluconate and isopropyl alcohol. Intravenous sedation/analgesia with midazolam and/or fentanyl will be titrated for patient comfort as is standard for peripheral nerve block administration. The nerves treated will include the sciatic proximal to the popliteal crease for foot surgery and the brachial plexus for shoulder surgery. The target nerve(s) will be visualized with ultrasound using a transverse cross-sectional (short axis) view and a skin wheal of local anesthetic will be raised inferior to the transducer to anesthetize the skin and then the track towards the target. The RELAY with the integrated needle will be inserted adjacent to the target nerve with an in-plane approach. Dextrose 5% in water (1-20 mL) will be injected via the needle to open a space around the target nerve(s), the catheter advanced, and the needle subsequently withdrawn.
Electrical current will be introduced with increasing intensity via each of the anode electrodes to optimize participant's perceived stimulation (control provided by the Gate Keeper app from an investigator's phone or tablet). Accurate lead placement will be confirmed with subject reports of comfortable sensations over the surgical site without eliciting muscle contractions. The minimum threshold and maximum comfortable amplitudes will be determined along with the optimal frequency, pulse duration, and anode/cathode. Starting from the lowest possible current the investigators increase the current until the participant states that they feel a "buzzing" sensation (some describe it as a "comfortable massage"). That is the minimal sensed current. The investigators then continue increasing with the instructions to let us know when it starts to be less comfortable-and to stop us before it hurts. That is the maximum comfortable current. The stimulator will be then set to deliver the minimum threshold amplitude and turned off for surgery. The pulse generator of the RELAY has a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). The investigators will maximize frequency, minimize pulse duration, and have participants adjust the amplitude following surgery, as needed.
Local anesthetic (10 mL of lidocaine 2% with epinephrine) will be injected with negative aspiration every 3 mL and resulting sensory block confirmed to ensure accurate catheter tip placement. Following block confirmation (sensory deficits in the expected nerve distributions), the RELAY will be affixed with both surgical adhesive (2-Octyl 2-cyanoacrylate) at the entry site and a chlorohexidine-impregnated occlusive dressing [research specific]. Subsequently, 10 mL of bupivacaine 0.5% with epinephrine will be injected negative aspiration every 3 mL along with a supplemental single-injection saphenous nerve block for foot/ankle surgery.
Intraoperatively, surgeons will be permitted to infiltrate the surgical area with long-acting local anesthetic as their common practice dictates.
Postoperatively, the stimulators will be connected to participants' phones and turned on. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be provided per standard UC San Diego protocol. After 7 days, participants themselves or their caretaker will remove the occlusive dressing and withdraw the catheter (and integrated electrodes) with gentle traction and rotation at home. The devices are single-use and disposable.
- Being tested
- Experimental Treatment
- Medical subject headings
- Rotator Cuff Injuries, Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental TreatmentDevice
Also called percutaneous peripheral nerve stimulation
Percutaneous peripheral nerve stimulation with a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). If the same pattern holds for the RELAY device as for previously tested peripheral nerve stimulators, we will maximize frequency, minimize pulse duration, and have participants adjust the amplitude, as needed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7. Receives: Device: Experimental Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Pain Intensity 1st Week
The median of 5 daily "average" pain intensity scores for Days 1-4 and 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst)
Measured: Days 1-4 and 7
Secondary outcomes (11)
Cumulative Opioid Use 1st Week
The cumulative opioid use measured in oxycodone equivalents during the first 7 days following surgery
Measured: The first 7 days following surgery
Brief Pain Inventory (Interference Sub Scale) Day 3
The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale; (2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include solely the interference subscale with a minimum score of 0 (optimal outcome) and maximum score of 70 (worst possible outcome).
Measured: Postoperative day 3
Brief Pain Inventory (Interference Sub Scale) Day 7
The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale; (2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include solely the interference subscale with a minimum score of 0 (optimal outcome) and maximum score of 70 (worst possible outcome).
Measured: Postoperative day 7
Worst Daily Pain Intensity 1st Week
The median of 5 daily "worst" (maximum) pain intensity scores for Days 1-4 and 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst)
Measured: Days 1-4 and 7
Awakenings Due to Pain 1st Week
Cumulative number of nightly awakenings due to pain
Measured: Collected on postoperative days 1, 2, 3, 4, and 7
Average Daily Pain Intensity Day 7
The "average" pain intensity score on Day 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst)
Measured: Day 7
Worst (Maximum) Daily Pain Intensity Day 7
The "worst" pain intensity score on Day 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst)
Measured: Day 7
Opioid Consumption Day 7
The cumulative opioid use from the previous 24 hours measured in oxycodone equivalents as recorded on Day 7
Measured: Day 7
Daily "Average" Pain Intensity
The "average" pain intensity score on each postoperative day as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst)
Measured: postoperative Days 1, 2, 3, 4, 7, 8 and 14
Daily "Worst" Pain Intensity
The "worst" pain intensity score on each postoperative day as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst)
Measured: postoperative Days 1, 2, 3, 4, 7, 8 and 14
Daily Opioid Consumption
The cumulative opioid use from the previous 24 hours measured in oxycodone equivalents as recorded on Days 1-4, 7, 8, and 14
Measured: postoperative Days 1, 2, 3, 4, 7, 8 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start20 Mar 2025
- Primary completion12 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- A series of participants all receiving active treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Gate Science
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, MD, Ms, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818708
- Sponsor's protocol ID
- RELAY Feasibility
- Status last verified
- Oct 2025
- First submitted
- 7 Feb 2025
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ilfeld BM, Said ET, Park BH, Sinha SK, Leek B, Meunier MJ, Foran IM, Hurvitz A, Kent WT, Schwartz AK, Abdullah B, Alkabalan R, Lau N, Finneran JJ. Percutaneous analgesic device enabling both local anesthetic delivery and electrical stimulation (neuromodulation) of peripheral nerves: a pilot feasibility study (case series). Reg Anesth Pain Med. 2026 May 5;51(5):498-503. doi: 10.1136/rapm-2025-107029.
PubMed 41005804
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blinded, Sham-Controlled Study Evaluating the Efficacy and Safety of RELAY, a Device Enabling Both Local Anesthetic Delivery and Neuromodulation Following Shoulder or Foot Surgery: Single Arm Training Run-In Phase
- ClinicalTrials.gov ID
- NCT06818708
- Acronym / sponsor ID
- RELAY Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Gate Science
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to prepare for a randomized clinical trial investigating the use of the RELAY device to provide postoperative analgesia.
This feasibility study will be a series of participants all receiving both local anesthetic and electric current via a single device (RELAY, Gate Science, Moultonborough, New Hampshire). The purpose will be to optimize the insertion approach and stimulation administration during the first 7 days following foot and shoulder surgery as well as training the clinical investigators.
Detailed description
Specific Aim: To determine the feasibility and optimize the protocol for the RELAY device following foot and shoulder surgery to prepare for the subsequent randomized, controlled pilot study.
For individuals of childbearing potential, a sample of urine will be collected before any study interventions to confirm a non-pregnant state (this is standard procedure for all surgical patients). The RELAY device combines a catheter-over-needle to permit ultrasound-guided percutaneous insertion with the tip adjacent to a peripheral nerve or plexus, followed by needle removal which leaves the catheter in situ to deliver a bolus of local anesthetic (if desired) and subsequent perineural local anesthetic infusion (if desired). The catheter also has 3 integrated electrodes to enable neuromodulation using the integrated pulse generator and battery.
Participants will have standard external monitors placed and oxygen delivered by facemask or nasal cannula. The peripheral nerve block site(s) will be cleansed with chlorhexidine gluconate and isopropyl alcohol. Intravenous sedation/analgesia with midazolam and/or fentanyl will be titrated for patient comfort as is standard for peripheral nerve block administration. The nerves treated will include the sciatic proximal to the popliteal crease for foot surgery and the brachial plexus for shoulder surgery. The target nerve(s) will be visualized with ultrasound using a transverse cross-sectional (short axis) view and a skin wheal of local anesthetic will be raised inferior to the transducer to anesthetize the skin and then the track towards the target. The RELAY with the integrated needle will be inserted adjacent to the target nerve with an in-plane approach. Dextrose 5% in water (1-20 mL) will be injected via the needle to open a space around the target nerve(s), the catheter advanced, and the needle subsequently withdrawn.
Electrical current will be introduced with increasing intensity via each of the anode electrodes to optimize participant's perceived stimulation (control provided by the Gate Keeper app from an investigator's phone or tablet). Accurate lead placement will be confirmed with subject reports of comfortable sensations over the surgical site without eliciting muscle contractions. The minimum threshold and maximum comfortable amplitudes will be determined along with the optimal frequency, pulse duration, and anode/cathode. Starting from the lowest possible current the investigators increase the current until the participant states that they feel a "buzzing" sensation (some describe it as a "comfortable massage"). That is the minimal sensed current. The investigators then continue increasing with the instructions to let us know when it starts to be less comfortable-and to stop us before it hurts. That is the maximum comfortable current. The stimulator will be then set to deliver the minimum threshold amplitude and turned off for surgery. The pulse generator of the RELAY has a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). The investigators will maximize frequency, minimize pulse duration, and have participants adjust the amplitude following surgery, as needed.
Local anesthetic (10 mL of lidocaine 2% with epinephrine) will be injected with negative aspiration every 3 mL and resulting sensory block confirmed to ensure accurate catheter tip placement. Following block confirmation (sensory deficits in the expected nerve distributions), the RELAY will be affixed with both surgical adhesive (2-Octyl 2-cyanoacrylate) at the entry site and a chlorohexidine-impregnated occlusive dressing [research specific]. Subsequently, 10 mL of bupivacaine 0.5% with epinephrine will be injected negative aspiration every 3 mL along with a supplemental single-injection saphenous nerve block for foot/ankle surgery.
Intraoperatively, surgeons will be permitted to infiltrate the surgical area with long-acting local anesthetic as their common practice dictates.
Postoperatively, the stimulators will be connected to participants' phones and turned on. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be provided per standard UC San Diego protocol. After 7 days, participants themselves or their caretaker will remove the occlusive dressing and withdraw the catheter (and integrated electrodes) with gentle traction and rotation at home. The devices are single-use and disposable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A series of participants all receiving active treatment
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Device: Experimental TreatmentRELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participants of at least 18 years of age
- Undergoing a rotator cuff repair, total shoulder arthroplasty, ankle arthroplasty/arthrodesis, or foot surgery anticipated to result in moderate-to-severe pain for at least one week
- Planned single-injection peripheral nerve block(s)
- An Android or Apple smartphone able to download the Gate Keeper controller app
Key exclusion criteria (16 listed)
- Chronic opioid or tramadol use (daily within prior 2 weeks and duration > 4 weeks)
- Neuro-muscular deficit of the surgical limb
- Compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk of infection
- Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap
- History of bleeding disorder
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 |
|---|---|---|
| Experimental TreatmentAlso: percutaneous peripheral nerve stimulationPercutaneous peripheral nerve stimulation with a frequency between 1-250 Hz, a pulse duration of 1-200 µs, and a current of 0.001-10 mA (1-10,000 µA). If the same pattern holds for the RELAY device as for previously tested peripheral nerve stimulators, we will maximize frequency, minimize pulse duration, and have participants adjust the amplitude, as needed. | Device | Experimental Treatment |
Primary outcome
Average Daily Pain Intensity 1st Week
Time frame: Days 1-4 and 7
The median of 5 daily "average" pain intensity scores for Days 1-4 and 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst)
11 secondary outcomes
Cumulative Opioid Use 1st Week
Time frame: The first 7 days following surgery
Brief Pain Inventory (Interference Sub Scale) Day 3
Time frame: Postoperative day 3
Brief Pain Inventory (Interference Sub Scale) Day 7
Time frame: Postoperative day 7
Worst Daily Pain Intensity 1st Week
Time frame: Days 1-4 and 7
Awakenings Due to Pain 1st Week
Time frame: Collected on postoperative days 1, 2, 3, 4, and 7
Average Daily Pain Intensity Day 7
Time frame: Day 7
Worst (Maximum) Daily Pain Intensity Day 7
Time frame: Day 7
Opioid Consumption Day 7
Time frame: Day 7
Daily "Average" Pain Intensity
Time frame: postoperative Days 1, 2, 3, 4, 7, 8 and 14
Daily "Worst" Pain Intensity
Time frame: postoperative Days 1, 2, 3, 4, 7, 8 and 14
Daily Opioid Consumption
Time frame: postoperative Days 1, 2, 3, 4, 7, 8 and 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41005804Ilfeld BM, Said ET, Park BH, Sinha SK, Leek B, Meunier MJ, Foran IM, Hurvitz A, Kent WT, Schwartz AK, Abdullah B, Alkabalan R, Lau N, Finneran JJ. Percutaneous analgesic device enabling both local anesthetic delivery and electrical stimulation (neuromodulation) of peripheral nerves: a pilot feasibility study (case series). Reg Anesth Pain Med. 2026 May 5;51(5):498-503. doi: 10.1136/rapm-2025-107029.
- article containing the resultsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Brian M Ilfeld, MD, Ms principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Treatment in people with Rotator Cuff Injuries and Shoulder Disease, run by University of California, San Diego at 1 site in United States.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Pain Intensity 1st Week (time frame: Days 1-4 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06818708, which also lists 1 linked publication.
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 18 Nov 2025.