Anesthesia, LocalNCT03807505
Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery
A study testing Interscalene brachial plexus nerve block and Erector spinae plane block in people with Anesthesia, Local and Phrenic Nerve Paralysis, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is the evaluation of erector spinae plane (ESP) blocks as an alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total shoulder arthroplasty procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Phrenic Nerve Paralysis, Upper Extremity Injury
- What is being tested?
- Interscalene brachial plexus nerve block and Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All adult patients (18 years and over) scheduled for rotator cuff surgery or total shoulder arthroplasty surgery requiring a nerve block as part of their anesthetic care
Who cannot join
- concomitant life-threatening injuries and other concomitant injuries causing significant pain.
- pregnancy,
- any condition impairing patient's ability to consent to participation in study
- an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder
- infection in the vicinity of the block, and patient refusal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Health Care (SHC)
Palo Alto, California, 94304
About this study
The goal of this study is the evaluation of erector spinae plane (ESP) blocks as an alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total shoulder arthroplasty procedures. Currently, single shot interscalene nerve blocks are performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for total shoulder arthroplasty surgeries. Erector spinae plane blocks are commonly used as part of the anesthetic plan for other surgeries, but less so for shoulder surgeries. The investigators would like to study whether an ESP block can provide similar pain control compared to an interscalene nerve block, with less risk of upper extremity motor block and phrenic nerve block.
- Being tested
- Interscalene brachial plexus nerve block, Erector spinae plane block
- Medical subject headings
- Arm Injuries, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus nerve blockProcedure or surgery
An interscalene brachial plexus nerve block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.
Erector spinae plane blockProcedure or surgery
An erector spinae plane block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene nerve block | Active comparator | Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot interscalene brachial plexus nerve block or an interscalene brachial plexus nerve catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively. Receives: Procedure: Interscalene brachial plexus nerve block |
| Erector Spinae Plane block | Active comparator | Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot erector spinae plane block or receive erector spinae plane catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively. Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diaphragmatic paresis or paralysis
Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery
Measured: Before block placement, and 30 minutes after catheter is bolused in recovery
Pain score
Pain scores for all patients will be recorded through the first 48 hours postoperatively using the Numeric Rating scale (ranging from 0 to 10, 0 is no pain and 10 is the worst imaginable pain).
Measured: 48 hours
Secondary outcomes (6)
Brachial plexus sensory exam change
Brachial plexus sensory exam change: dichotomous measurement (yes or no) for change in sensation over C5-C8 dermatomes
Measured: Before block placement, and 30 minutes after catheter is bolused in recovery
Brachial plexus motor exam change
Brachial plexus motor exam change: dichotomous measurement (yes or no) for change in finger extension, finger abduction and thumb opposition to resistance
Measured: Before block placement, and 30 minutes after catheter is bolused in recovery
Opioid Consumption
Opioid consumption in the recovery room and in the first 48 hours postoperatively will be recorded
Measured: 48 hours
Adverse effects
Patient-reported adverse effects (dichotomous measure, yes/no): dyspnea, Horner syndrome, hoarseness, difficulty participating in physical therapy due to block
Measured: 72 hours
Patient satisfaction
Patient satisfaction with the nerve block (dichotomous measure: yes/no)
Measured: 72 hours
Incentive spirometry volume change
Change in incentive spirometry volume from baseline (prior to block) to recovery room, and to postoperative day 1.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start13 Jun 2019
- Primary completion22 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Ho Ban Tsui, Stanford University
- Investigators
- Ban Tsui, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807505
- Sponsor's protocol ID
- 48351
- Status last verified
- Mar 2020
- First submitted
- 14 Dec 2018
- Last updated
- 5 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.
PubMed 18682410Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.
PubMed 29868941Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.
PubMed 29134518Sun LY, Basireddy S, Gerber LN, Lamano J, Costouros J, Cheung E, Boublik J, Horn JL, Tsui BCH. Continuous interscalene versus phrenic nerve-sparing high-thoracic erector spinae plane block for total shoulder arthroplasty: a randomized controlled trial. Can J Anaesth. 2022 May;69(5):614-623. doi: 10.1007/s12630-022-02216-1. Epub 2022 Mar 2.
PubMed 35237953
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery
- ClinicalTrials.gov ID
- NCT03807505
- Acronym / sponsor ID
- 48351
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Jan 2019 (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 goal of this study is the evaluation of erector spinae plane (ESP) blocks as an alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total shoulder arthroplasty procedures. Currently, single shot interscalene nerve blocks are performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for total shoulder arthroplasty surgeries. Erector spinae plane blocks are commonly used as part of the anesthetic plan for other surgeries, but less so for shoulder surgeries. The investigators would like to study whether an ESP block can provide similar pain control compared to an interscalene nerve block, with less risk of upper extremity motor block and phrenic nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene nerve block | Active comparator | Procedure: Interscalene brachial plexus nerve blockPatients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot interscalene brachial plexus nerve block or an interscalene brachial plexus nerve catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively. |
| Erector Spinae Plane block | Active comparator | Procedure: Erector spinae plane blockPatients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot erector spinae plane block or receive erector spinae plane catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (18 years and over) scheduled for rotator cuff surgery or total shoulder arthroplasty surgery requiring a nerve block as part of their anesthetic care
Key exclusion criteria (5 listed)
- concomitant life-threatening injuries and other concomitant injuries causing significant pain.
- pregnancy,
- any condition impairing patient's ability to consent to participation in study
- an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder
- infection in the vicinity of the block, and patient refusal.
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 |
|---|---|---|
| Interscalene brachial plexus nerve blockAn interscalene brachial plexus nerve block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit. | Procedure or surgery | Interscalene nerve block |
| Erector spinae plane blockAn erector spinae plane block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit. | Procedure or surgery | Erector Spinae Plane block |
Primary outcome
Incidence of diaphragmatic paresis or paralysis
Time frame: Before block placement, and 30 minutes after catheter is bolused in recovery
Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery
Pain score
Time frame: 48 hours
Pain scores for all patients will be recorded through the first 48 hours postoperatively using the Numeric Rating scale (ranging from 0 to 10, 0 is no pain and 10 is the worst imaginable pain).
6 secondary outcomes
Brachial plexus sensory exam change
Time frame: Before block placement, and 30 minutes after catheter is bolused in recovery
Brachial plexus motor exam change
Time frame: Before block placement, and 30 minutes after catheter is bolused in recovery
Opioid Consumption
Time frame: 48 hours
Adverse effects
Time frame: 72 hours
Patient satisfaction
Time frame: 72 hours
Incentive spirometry volume change
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Background: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Background: PubMed 18682410Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.
- Background: PubMed 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Background: PubMed 29868941Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.
- Background: PubMed 29134518Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.
- Derived from this study: PubMed 35237953Sun LY, Basireddy S, Gerber LN, Lamano J, Costouros J, Cheung E, Boublik J, Horn JL, Tsui BCH. Continuous interscalene versus phrenic nerve-sparing high-thoracic erector spinae plane block for total shoulder arthroplasty: a randomized controlled trial. Can J Anaesth. 2022 May;69(5):614-623. doi: 10.1007/s12630-022-02216-1. Epub 2022 Mar 2.
- 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.
Ban Tsui, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene brachial plexus nerve block and Erector spinae plane block in people with Anesthesia, Local and Phrenic Nerve Paralysis, run by Stanford University 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 1 inclusion and 5 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 5 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of diaphragmatic paresis or paralysis (time frame: Before block placement, and 30 minutes after catheter is bolused in recovery). The study lists 2 primary outcomes in all. 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 NCT03807505, which also lists 6 linked publications.
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 5 Mar 2020.