Postoperative Pain, AcuteNCT05653570
Electrical Stimulation for Erector Spinae Plane Catheter Insertion
A study testing Electrical stimulation and Ultrasound in people with Postoperative Pain, Acute and Shoulder Pain, run by Stanford University.
Trial summary
The erector spinae plane (ESP) block has been studied for analgesia in shoulder surgery as a phrenic nerve-sparing alternative. However, successful ESP catheter placement appears multifactorial, with failure mechanisms including lamination, plane collapse, or catheter overcoiling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Acute, Shoulder Pain
- What is being tested?
- Electrical stimulation and Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Nov 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
- elective total or total reverse shoulder arthroplasty
Who cannot join
- inability to provide consent
- history of active opioid use
- emergency procedures
- shoulder arthroscopy
- partial shoulder replacement
- shoulder resurfacing
- any revision shoulder surgery
- any indwelling deep brain stimulator, pacemaker, and/or other neurostimulators
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Electrical Stimulation for Erector Spinae Plane Catheter Insertion: A Randomized Controlled Trial
The erector spinae plane (ESP) block has been studied for analgesia in shoulder surgery as a phrenic nerve-sparing alternative. However, successful ESP catheter placement appears multifactorial, with failure mechanisms including lamination, plane collapse, or catheter overcoiling. Electrical stimulation (ES) is a common technique used in regional anesthesia to detect possible intraneural placement. ES of the erector spinae muscle complex may objectively guide proper interfascial catheter placement and improve local anesthetic spread. The primary goal of this study is to establish if ESP catheter placement with the addition of ES to ultrasound (US) guidance facilitates accurate catheter placement. This study will further characterize postoperative analgesia and the incidence of brachial plexus stimulation for patients who receive ES-assisted ESP catheter placement.
- Conditions
- Postoperative Pain, Acute, Shoulder Pain
- Being tested
- Electrical stimulation, Ultrasound
- Keywords
- erector spinae plane, electrical stimulation
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationDiagnostic test
Electrical stimulation will be used to confirm needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.
UltrasoundDiagnostic test
Ultrasound guidance will be used to visualize needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guidance Only | Active comparator | Not described Receives: Diagnostic Test: Ultrasound |
| Electrical stimulation and Ultrasound Guidance | Experimental | Not described Receives: Diagnostic Test: Electrical stimulation; Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with erector spinae muscle stimulation via stimulating catheter
Successful erector spinae plane needle and catheter insertion means that the needle/catheter is deep to the myofascia of the erector spinae muscle complex and superficial to the intertransverse ligaments / transverse process. Thus, any stimulation of the catheter after its placement in the erector spinae muscle complex seen under ultrasound or perceived by the patient will be documented as catheter placement failure. No visualized or perceived stimulation of the erector spinae muscle complex will be documented as catheter placement success.
Measured: Immediately after catheter placement (up to 5 minutes to assess)
Secondary outcomes (12)
Time to perform erector spinae plane catheter
Time for catheter placement will begin when the US probe first touches the patient and end when the inner stimulating catheter hub meets the skin. If no visual identification of the target erector spinae plane (US) and no evoked motor respoinse (US+ES) is achieved within 10 minutes, the placement will be considered a failure, and the primary end point will be recorded as 10 minutes. If a catheter cannot be placed per protocol within 20 minutes, the placement will be considered a failure, and the primary endpoint will be recorded as 20 minutes. In such cases, the subject will have a catheter placement attempt using the alternative method. Subjects who do not have a catheter placed as per their randomized group protocol will be removed from further study.
Measured: During catheter placement (up to 20 minutes)
Worst pain score ratings in the postanesthesia care unit (PACU)
As soon as the patient is able to respond verbally in the PACU, the subject will be asked to rate their pain on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
Measured: as soon as patient can respond in PACU (up to 1 hour)
Highest and lowest vertebral level of sensory change after local anesthetic bolus
We will administer cold spray (name, manufacturer location) 3 cm lateral to the spinous process from C1 to T12, and document the highest and lowest dermatomal levels of when the patient detects a difference in temperature sensation compared to the contralateral side.
Measured: preoperatively, 30 minutes after local anesthetic bolus
Incidence of brachial plexus or intercostal stimulation via stimulating catheter before local anesthetic bolus
Prior to local anesthetic bolus, any perceived stimulation of an intercostal muscle or in the distribution of the brachial plexus on the operative side, including but not limited to twitching of or warmth of skin overlying the deltoid, biceps, triceps, supraspinatus, infraspinatus, pectoralis major/minor, and teres major/minor, will be documented.
Measured: preoperatively, prior to local anesthetic bolus (up to 5 minutes)
Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus
30 minutes after local anesthetic bolus, any perceived stimulation of an intercostal muscle or in the distribution of the brachial plexus on the operative side, including but not limited to twitching of or warmth of skin overlying the deltoid, biceps, triceps, supraspinatus, infraspinatus, pectoralis major/minor, and teres major/minor, will be documented.
Measured: preoperatively, 30 minutes after local anesthetic bolus
Opioid consumption in the PACU
The subject's total opioid administration in the PACU will be documented and converted to oral morphine milliequivalents (MME).
Measured: from admission to discharge from the PACU (average approximately 2 hours)
Opioid consumption on postoperative day (POD) 1
The subject's total opioid administration on POD1 will be documented and converted to oral morphine milliequivalents (MME).
Measured: POD1 (24 hours)
Opioid consumption on postoperative day (POD) 2
The subject's total opioid administration on POD2 will be documented and converted to oral morphine milliequivalents (MME).
Measured: POD2 (24 hours)
Opioid consumption on postoperative day (POD) 3
The subject's total opioid administration on POD3 will be documented and converted to oral morphine milliequivalents (MME).
Measured: POD3 (24 hours)
Average postoperative pain on postoperative day (POD) 1
The subject's average postoperative pain score ratings will be calculated on POD 1. Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
Measured: POD1 (24 hours)
Average postoperative pain on postoperative day (POD) 2
The subject's average postoperative pain score ratings will be calculated on POD 2 Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
Measured: POD2 (24 hours)
Average postoperative pain on postoperative day (POD) 3
The subject's average postoperative pain score ratings will be calculated on POD 3 Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
Measured: POD3 (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Boublik, Stanford University
- Investigators
- Jan Boublik, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653570
- Sponsor's protocol ID
- 68478
- Status last verified
- Nov 2024
- First submitted
- 8 Dec 2022
- Last updated
- 21 Apr 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 21 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation for Erector Spinae Plane Catheter Insertion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05653570
- Acronym / sponsor ID
- 68478
- Conditions
- Postoperative Pain, Acute, Shoulder Pain
- Keywords
- erector spinae plane, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Dec 2022 (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.
The erector spinae plane (ESP) block has been studied for analgesia in shoulder surgery as a phrenic nerve-sparing alternative. However, successful ESP catheter placement appears multifactorial, with failure mechanisms including lamination, plane collapse, or catheter overcoiling. Electrical stimulation (ES) is a common technique used in regional anesthesia to detect possible intraneural placement. ES of the erector spinae muscle complex may objectively guide proper interfascial catheter placement and improve local anesthetic spread. The primary goal of this study is to establish if ESP catheter placement with the addition of ES to ultrasound (US) guidance facilitates accurate catheter placement. This study will further characterize postoperative analgesia and the incidence of brachial plexus stimulation for patients who receive ES-assisted ESP catheter placement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guidance Only | Active comparator | Diagnostic Test: Ultrasound |
| Electrical stimulation and Ultrasound Guidance | Experimental | Diagnostic Test: Electrical stimulation, Diagnostic Test: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective total or total reverse shoulder arthroplasty
Key exclusion criteria (8 listed)
- inability to provide consent
- history of active opioid use
- emergency procedures
- shoulder arthroscopy
- partial shoulder replacement
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 |
|---|---|---|
| Electrical stimulationElectrical stimulation will be used to confirm needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process. | Diagnostic test | Electrical stimulation and Ultrasound Guidance |
| UltrasoundUltrasound guidance will be used to visualize needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process. | Diagnostic test | Electrical stimulation and Ultrasound Guidance, Ultrasound Guidance Only |
Primary outcome
Number of patients with erector spinae muscle stimulation via stimulating catheter
Time frame: Immediately after catheter placement (up to 5 minutes to assess)
Successful erector spinae plane needle and catheter insertion means that the needle/catheter is deep to the myofascia of the erector spinae muscle complex and superficial to the intertransverse ligaments / transverse process. Thus, any stimulation of the catheter after its placement in the erector spinae muscle complex seen under ultrasound or perceived by the patient will be documented as catheter placement failure. No visualized or perceived stimulation of the erector spinae muscle complex will be documented as catheter placement success.
12 secondary outcomes
Time to perform erector spinae plane catheter
Time frame: During catheter placement (up to 20 minutes)
Worst pain score ratings in the postanesthesia care unit (PACU)
Time frame: as soon as patient can respond in PACU (up to 1 hour)
Highest and lowest vertebral level of sensory change after local anesthetic bolus
Time frame: preoperatively, 30 minutes after local anesthetic bolus
Incidence of brachial plexus or intercostal stimulation via stimulating catheter before local anesthetic bolus
Time frame: preoperatively, prior to local anesthetic bolus (up to 5 minutes)
Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus
Time frame: preoperatively, 30 minutes after local anesthetic bolus
Opioid consumption in the PACU
Time frame: from admission to discharge from the PACU (average approximately 2 hours)
Opioid consumption on postoperative day (POD) 1
Time frame: POD1 (24 hours)
Opioid consumption on postoperative day (POD) 2
Time frame: POD2 (24 hours)
Opioid consumption on postoperative day (POD) 3
Time frame: POD3 (24 hours)
Average postoperative pain on postoperative day (POD) 1
Time frame: POD1 (24 hours)
Average postoperative pain on postoperative day (POD) 2
Time frame: POD2 (24 hours)
Average postoperative pain on postoperative day (POD) 3
Time frame: POD3 (24 hours)
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 21 Apr 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.
Jan Boublik, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation and Ultrasound in people with Postoperative Pain, Acute and Shoulder Pain, run by Stanford University.
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 1 inclusion and 8 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 21 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jan Boublik, MD ((917) 617-6261, jboublik@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with erector spinae muscle stimulation via stimulating catheter (time frame: Immediately after catheter placement (up to 5 minutes to assess)). 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 21 Apr 2025.