Pain ManagementNCT04401007
Erector Spinae Plane (ESP) Block Volunteer Study
A study testing Erector Spinae Plane Block with 1.5% lidocaine in people with Pain Management, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Although erector spinae plane (ESP) block reportedly provides postoperative pain relieve, controversy remains regarding the accuracy and consistency of analgesic success following ESP block. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Erector Spinae Plane Block with 1.5% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jul 2021to 20 Nov 2023
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA 1 (normal healthy) volunteers
- 18 - 50 years of age
- 60- 100 kg weight
- English speaking
- female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate, females of child bearing potential must be willing to use medically acceptable birth control methods for a minimum of 2 weeks following the nerve block.
Who cannot join
- weight < 60 kg (limited by the maximum lidocaine dose 7 mg/kg)
- medical disorders (including bleeding disorders)
- any recreational drug use
- allergy to local anesthetic (lidocaine, bupivacaine, ropivacaine)
- contraindication to regional anesthetic block
- inability to provide informed consent
Show all 9Show fewer
- baseline abnormality of chest, abdominal and back sensation
- pregnancy / breast feeding
- individuals with mental health disorders (for example bipolar disorder or depression).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Volunteer Study to Determine the Anesthetic and Analgesic Effect of the Erector Spinae Plane (ESP) Block
Although erector spinae plane (ESP) block reportedly provides postoperative pain relieve, controversy remains regarding the accuracy and consistency of analgesic success following ESP block. The goal of this study is to determine the extent and duration of clinical neural blockade following an ESP injection with different local anesthetic doses.
Methods Twenty four healthy volunteers will be recruited, and each subject will make 2 separate visits to the study centre to undergo intervention and assessment. The 2 study visits will be separated by an interval of at least 2 weeks to ensure complete washout of any residual effects and a return to baseline status.
Read more
At each study visit, the subject will receive a unilateral ESP block with 1.5% lidocaine and 5 mcg/mL epinephrine. Two different local anesthetic volumes will be investigated: 20 mL (300 mg lidocaine) at one study visit and 30 mL (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit; or (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit.
There will be 2 study subgroups based on the vertebral level at which the ESP block is administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at the T4 transverse process (TP4) level in order to evaluate the anesthetic effect on the chest wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8 transverse process (TP8) level in order to evaluate the anesthetic effect on the abdominal wall. The first 10 volunteer subjects recruited will receive ESP blocks at the TP4 level and the subsequent 10 subjects will receive ESP blocks at the TP8 level.
Read the detailed description
Erector spinae plane (ESP) block is a new regional nerve block technique that involves a percutaneous injection of local anesthetic as a bolus through a needle or catheter into the fascial plane between the erector spinae muscle and the transverse processes in the upper or mid back. Injection at the level of the T4-5 transverse process is indicated for chest wall pain relief while injection at the T8-9 level is for abdominal wall pain control. This block aims to relieve postoperative pain but is not intended to provide anesthetic blockade for surgery. Preliminary case reports and some randomized controlled trials show encouraging analgesic effect of ESP block for breast surgery, rib fracture, thoracotomy, sternotomy, epigastric hernia repair, open abdominal surgery, laparoscopic abdominal surgery, radical retropubic prostatectomy and hip arthroplasty. Although effective, controversy remains regarding the accuracy and consistency of analgesic success following ESP block.
Currently, it is unclear whether block inconsistency is due to improper injection technique or the mechanism of action. Presumably, local anesthetic following an ESP block injection will find its way antero-medially through the costotransverse foramen and / or inter transverse ligaments to enter the thoracic paravertebral space or epidural space to block the ventral rami of the thoracic spinal nerves. It may also spread laterally to reach the neighbouring intercostal nerves.
At this time, it is unclear whether cadaver injection studies showing dye spread to these anatomical spaces can fully explain the observed clinical neural blockade. Also a number of cadaver studies show inconsistent and conflicting dye spread results, i.e., failure to reach the thoracic paravertebral space. Although some suggest that an ESP block also provides sympathetic blockade thus may provide visceral pain relief, no study has evaluated the validity of such a claim or the extent of sympathetic blockade.
The mechanisms of action for an ESP block are currently unclear. Although most case reports describe analgesic effects of ESP block for anterior chest and abdominal surgery presumably as a result of blockade of the ventral rami of the spinal nerves in the thoracic paravertebral spaces, it is more likely that local anesthetic injected in the ESP will reliably anesthetize the dorsal rami traversing the erector spinae muscle in the back. This is supported by preliminary clinical analgesic success of ESP block for thoracic spine surgery and lumbar spine surgery. The consistency of blocking the ventral and dorsal rami following an ESP block injection is unknown at this time.
Investigators' clinical experience further confirms that an ESP injection provides variable analgesic results and an objective sign of sensory anesthesia to pinprick or ice is not consistently evident. Currently no study has examined the optimal technique of ESP block injection, peak blood local anesthetic level after injection, the effect of spine movement (i.e., gliding movement of erector spinae muscle on the transverse processes) on neural blockade, and the consistency of this block technique. Also, most case reports on surgical patients did not report the onset, progression or resolution of ESP blockade or the extent of sensory and sympathetic blockade. From a clinical perspective, it would be very helpful to determine the extent and duration of clinical neural blockade following an ESP injection with different local anesthetic doses and such detailed examination is possible only in a carefully conducted volunteer study.
- Conditions
- Pain Management
- Being tested
- Erector Spinae Plane Block with 1.5% lidocaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block with 1.5% lidocaineOther
Erector spinae plane (ESP) block is a new regional nerve block technique that involves a percutaneous injection of local anesthetic as a bolus through a needle or catheter into the fascial plane between the erector spinae muscle and the transverse processes in the upper or mid back.
| Study group | Role | What they receive |
|---|---|---|
| Group 20/30 | Experimental | Two different local anesthetic volumes will be investigated: 20 mL of 1.5% lidocaine (300 mg lidocaine) at one study visit and 30 mL of 1.5% lidocaine (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit Receives: Other: Erector Spinae Plane Block with 1.5% lidocaine |
| Group 30/20 | Experimental | (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. This crossover design allows subjects to serve as their own control. Receives: Other: Erector Spinae Plane Block with 1.5% lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of sensory blockade Sensation to Pinprick of thoracic ventral rami
duration of ESP block Sensation to Pinprick
Measured: up to 10 hours
the duration of sensory blockade Sensation to Pinprick of thoracic dorsal rami
duration of ESP block Sensation to Pinprick
Measured: up to 10 hours
the duration of sensory blockade Sensation to temperature of thoracic ventral rami
duration of ESP block Sensation to different temperature
Measured: up to 10 hours
the duration of sensory blockade Sensation to temperature of thoracic dorsal rami
duration of ESP block Sensation to different temperature
Measured: up to 10 hours
Secondary outcomes (7)
To evaluate the onset of pinprick blockade of an ESP block injection
onset of ESP block on pinprick
Measured: up to 2 hours
To evaluate the onset of temperature blockade of an ESP block
onset of ESP block on temperature
Measured: up to 2 hours
To evaluate the regression of pinprick blockade of an ESP block injection
regression of the ESP block on pinprick
Measured: post-block 2-10 hours
To evaluate the regression of temperature blockade of an ESP block injection
regression of the ESP block on Skin Conductance
Measured: post-block 2-10 hours
To evaluate the success of blockade on Skin Conductance of an ESP block injection
post-block success of blockade on Skin Conductance
Measured: 0-2 hours
To evaluate the onset of blockade on Skin Conductance of an ESP block injection
the onset of blockade on Skin Conductance
Measured: post-block 0-2 hours
To evaluate the regression of blockade on Skin Conductance of an ESP block injection
the regression of blockade on Skin Conductance
Measured: post-block 2-10hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start28 Jul 2021
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Crossover
- Model description
- There will be 2 study subgroups based on the vertebral level at which the ESP block is administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at the T4 transverse process (TP4) level. Injection at the TP4 level will allow us to evaluate the anesthetic effect on the chest wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8 transverse process (TP8) level. Injection at the TP8 level will allow us to evaluate the anesthetic effect on the abdominal wall. The first 12 volunteer subjects recruited will receive ESP blocks at the TP4 level and the subsequent 12 subjects will receive ESP blocks at the TP8 level.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki Jinn Chin, MBBS, MMed,FRCPC, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401007
- Sponsor's protocol ID
- 19-5863.0
- Status last verified
- Jul 2026
- First submitted
- 11 May 2020
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Volunteer Study to Determine the Anesthetic and Analgesic Effect of the Erector Spinae Plane (ESP) Block
- ClinicalTrials.gov ID
- NCT04401007
- Acronym / sponsor ID
- 19-5863.0
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 26 May 2020 (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.
Although erector spinae plane (ESP) block reportedly provides postoperative pain relieve, controversy remains regarding the accuracy and consistency of analgesic success following ESP block. The goal of this study is to determine the extent and duration of clinical neural blockade following an ESP injection with different local anesthetic doses.
Methods Twenty four healthy volunteers will be recruited, and each subject will make 2 separate visits to the study centre to undergo intervention and assessment. The 2 study visits will be separated by an interval of at least 2 weeks to ensure complete washout of any residual effects and a return to baseline status.
At each study visit, the subject will receive a unilateral ESP block with 1.5% lidocaine and 5 mcg/mL epinephrine. Two different local anesthetic volumes will be investigated: 20 mL (300 mg lidocaine) at one study visit and 30 mL (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit; or (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit.
There will be 2 study subgroups based on the vertebral level at which the ESP block is administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at the T4 transverse process (TP4) level in order to evaluate the anesthetic effect on the chest wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8 transverse process (TP8) level in order to evaluate the anesthetic effect on the abdominal wall. The first 10 volunteer subjects recruited will receive ESP blocks at the TP4 level and the subsequent 10 subjects will receive ESP blocks at the TP8 level.
Detailed description
Erector spinae plane (ESP) block is a new regional nerve block technique that involves a percutaneous injection of local anesthetic as a bolus through a needle or catheter into the fascial plane between the erector spinae muscle and the transverse processes in the upper or mid back. Injection at the level of the T4-5 transverse process is indicated for chest wall pain relief while injection at the T8-9 level is for abdominal wall pain control. This block aims to relieve postoperative pain but is not intended to provide anesthetic blockade for surgery. Preliminary case reports and some randomized controlled trials show encouraging analgesic effect of ESP block for breast surgery, rib fracture, thoracotomy, sternotomy, epigastric hernia repair, open abdominal surgery, laparoscopic abdominal surgery, radical retropubic prostatectomy and hip arthroplasty. Although effective, controversy remains regarding the accuracy and consistency of analgesic success following ESP block.
Currently, it is unclear whether block inconsistency is due to improper injection technique or the mechanism of action. Presumably, local anesthetic following an ESP block injection will find its way antero-medially through the costotransverse foramen and / or inter transverse ligaments to enter the thoracic paravertebral space or epidural space to block the ventral rami of the thoracic spinal nerves. It may also spread laterally to reach the neighbouring intercostal nerves.
At this time, it is unclear whether cadaver injection studies showing dye spread to these anatomical spaces can fully explain the observed clinical neural blockade. Also a number of cadaver studies show inconsistent and conflicting dye spread results, i.e., failure to reach the thoracic paravertebral space. Although some suggest that an ESP block also provides sympathetic blockade thus may provide visceral pain relief, no study has evaluated the validity of such a claim or the extent of sympathetic blockade.
The mechanisms of action for an ESP block are currently unclear. Although most case reports describe analgesic effects of ESP block for anterior chest and abdominal surgery presumably as a result of blockade of the ventral rami of the spinal nerves in the thoracic paravertebral spaces, it is more likely that local anesthetic injected in the ESP will reliably anesthetize the dorsal rami traversing the erector spinae muscle in the back. This is supported by preliminary clinical analgesic success of ESP block for thoracic spine surgery and lumbar spine surgery. The consistency of blocking the ventral and dorsal rami following an ESP block injection is unknown at this time.
Investigators' clinical experience further confirms that an ESP injection provides variable analgesic results and an objective sign of sensory anesthesia to pinprick or ice is not consistently evident. Currently no study has examined the optimal technique of ESP block injection, peak blood local anesthetic level after injection, the effect of spine movement (i.e., gliding movement of erector spinae muscle on the transverse processes) on neural blockade, and the consistency of this block technique. Also, most case reports on surgical patients did not report the onset, progression or resolution of ESP blockade or the extent of sensory and sympathetic blockade. From a clinical perspective, it would be very helpful to determine the extent and duration of clinical neural blockade following an ESP injection with different local anesthetic doses and such detailed examination is possible only in a carefully conducted volunteer study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- There will be 2 study subgroups based on the vertebral level at which the ESP block is administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at the T4 transverse process (TP4) level. Injection at the TP4 level will allow us to evaluate the anesthetic effect on the chest wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8 transverse process (TP8) level. Injection at the TP8 level will allow us to evaluate the anesthetic effect on the abdominal wall. The first 12 volunteer subjects recruited will receive ESP blocks at the TP4 level and the subsequent 12 subjects will receive ESP blocks at the TP8 level.
| Arm | Type | Receives |
|---|---|---|
| Group 20/30 | Experimental | Other: Erector Spinae Plane Block with 1.5% lidocaineTwo different local anesthetic volumes will be investigated: 20 mL of 1.5% lidocaine (300 mg lidocaine) at one study visit and 30 mL of 1.5% lidocaine (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit |
| Group 30/20 | Experimental | Other: Erector Spinae Plane Block with 1.5% lidocaine(2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. This crossover design allows subjects to serve as their own control. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA 1 (normal healthy) volunteers
- 18 - 50 years of age
- 60- 100 kg weight
- English speaking
- female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate, females of child bearing potential must be willing to use medically acceptable birth control methods for a minimum of 2 weeks following the nerve block.
Key exclusion criteria (9 listed)
- weight < 60 kg (limited by the maximum lidocaine dose 7 mg/kg)
- medical disorders (including bleeding disorders)
- any recreational drug use
- allergy to local anesthetic (lidocaine, bupivacaine, ropivacaine)
- contraindication to regional anesthetic block
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 |
|---|---|---|
| Erector Spinae Plane Block with 1.5% lidocaineErector spinae plane (ESP) block is a new regional nerve block technique that involves a percutaneous injection of local anesthetic as a bolus through a needle or catheter into the fascial plane between the erector spinae muscle and the transverse processes in the upper or mid back. | Other | Group 20/30, Group 30/20 |
Primary outcome
the duration of sensory blockade Sensation to Pinprick of thoracic ventral rami
Time frame: up to 10 hours
duration of ESP block Sensation to Pinprick
the duration of sensory blockade Sensation to Pinprick of thoracic dorsal rami
Time frame: up to 10 hours
duration of ESP block Sensation to Pinprick
the duration of sensory blockade Sensation to temperature of thoracic ventral rami
Time frame: up to 10 hours
duration of ESP block Sensation to different temperature
the duration of sensory blockade Sensation to temperature of thoracic dorsal rami
Time frame: up to 10 hours
duration of ESP block Sensation to different temperature
7 secondary outcomes
To evaluate the onset of pinprick blockade of an ESP block injection
Time frame: up to 2 hours
To evaluate the onset of temperature blockade of an ESP block
Time frame: up to 2 hours
To evaluate the regression of pinprick blockade of an ESP block injection
Time frame: post-block 2-10 hours
To evaluate the regression of temperature blockade of an ESP block injection
Time frame: post-block 2-10 hours
To evaluate the success of blockade on Skin Conductance of an ESP block injection
Time frame: 0-2 hours
To evaluate the onset of blockade on Skin Conductance of an ESP block injection
Time frame: post-block 0-2 hours
To evaluate the regression of blockade on Skin Conductance of an ESP block injection
Time frame: post-block 2-10hours
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 31 Jul 2026.
- Individual participant dataSharing planned: No. No plan to share IPD with other researchers
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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.
Ki Jinn Chin, MBBS, MMed,FRCPC principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block with 1.5% lidocaine in people with Pain Management, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 9 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 31 Jul 2026. 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 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?
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?
the duration of sensory blockade Sensation to Pinprick of thoracic ventral rami (time frame: up to 10 hours). The study lists 4 primary outcomes in all. 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 31 Jul 2026.