Breast CancerNCT03978780
Erector Spinae Block vs. Placebo Block Study
A study testing Erector spinae plane block in people with Breast Cancer and Nerve Block, run by Women's College Hospital at 1 site in Canada.
Trial summary
Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Nerve Block, Regional Anesthesia
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2026to Jan 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA classification: I-III
- BMI < 35 kg/m2
- Day surgery procedure
Who cannot join
- Prior ipsilateral breast surgery, excluding lumpectomy
- Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
- Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases
- Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)
- Contraindication to regional anaesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)
- Patient refusal
Show all 15Show fewer
- Chronic pain disorder
- Chronic opioid use (≥30 mg oxycodone / day)
- Contraindication (or allergy) to a component of multi-modal analgesia protocol
- Allergy to amide local anaesthetics used in nerve blocks
- Contraindications to any of the components of the standardized general anaesthesia
- Significant psychiatric disorder that would preclude objective study assessment
- Pregnancy/ women with nursing infants
- Unable to provide informed consent
- Unable to speak and read English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Women's College Hospital
Toronto, Ontario, M5S 1B2
Richard Brull, MD, 416-323-6400 ext. 4239, richard.brull@wchospital.ca
Didem Bozak, 416-323-6400 ext. 6008, didem.bozak@wchospital.ca
About this study
Official title: Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled Trial
Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. It enhances multi-modal analgesia regimes while being opioid sparing, reducing incidence of post-operative nausea and vomiting and allowing earlier mobilisation/discharge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.
Read the detailed description
The ultrasound-guided erector spinae plane (ESP) block has been recently described for the successful management of thoracic neuropathic pain. The erector spinae muscle is formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anaesthetic in the fascial plane, deep to the erector spinae muscle, at the tip of the transverse process of the vertebra. Indirect access to the paravertebral space is gained providing analgesia without the risk of needle injury to structures in close proximity. Cadaveric studies have shown both ventral and dorsal rami of thoracic spinal nerves are affected when local anaesthetic is injected deep to the erector spinae muscle. The erector spinae muscle extends along the thoracolumbar spine allowing extensive cranio-caudal spread. The ventral ramus (intercostal nerve) is divided into the anterior and lateral branches. Its terminal branches provide the sensory innervation of the entire anterolateral wall. The dorsal ramus is divided into 2 terminal branches and it gives the sensory innervation to the posterior wall. Anterior spread of the local anaesthetic to the paravertebral space through the costotransverse foramina and the intertransverse complex provides both visceral and somatic analgesia.
While recent evidence supports statistically significant reductions in pain and opioid consumption among patients who receive an ESP block compared to systemic analgesia alone, the clinical significance of these differences are questionable the effect of ESP block on the patients' quality of recovery following ambulatory breast cancer surgery remains unclear.
Therefore, our objective is to determine whether or not the addition of an ESP block provides both superior analgesia and quality of recovery in patients undergoing ambulatory breast cancer surgery compared to systemic analgesia alone. We hypothesis that patients who received a preoperative ESP block will afford superior postoperative analgesia and improve the quality of recovery over the first 24 hours following surgery compared to those who receive a sham block for their ambulatory breast cancer surgery.
- Being tested
- Erector spinae plane block, Placebo Block
- Keywords
- Spinae fascial plane block, Breast surgery, interfascial plane block, erector spinae block
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed.
Placebo BlockProcedure or surgery
Patients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block under ultrasound guidance to stimulate a real block procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block (see above) under ultrasound guidance to stimulate a real block procedure. Receives: Procedure: Placebo Block |
| Erector spinae plane (ESP) block group | Experimental | Local anaesthetic infiltration utilising 1% lidocaine will occur, and an 80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed. Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperative pain at rest
Following breast surgery, measured as an area under the curve (AUC) of rest pain scores VAS scale where 0 corresponds to no pain, and 10 corresponds to worst pain imaginable
Measured: 24 hours postoperatively
Quality of postoperative recovery (QoR 15)
Quality of recovery at 24 hours: questionnaire (0-10, where 0 = none of the time [poor] and 10 = all of the time [excellent])
Measured: 24 hours post-surgery
Secondary outcomes (7)
Postoperative pain scores
VAS scale where 0 corresponds to no pain, and 10 corresponds to worst pain imaginable
Measured: 0, 6, 12, 18, 24 and 48 hours post-operatively
Intraoperative opioid consumption
Cumulative oral morphine equivalent after surgery
Measured: During the procedure
Postoperative opioid consumption
Cumulative oral morphine equivalent after surgery
Measured: 12,24,48 hours, 7 days postoperative
Duration of phase I (PACU) and phase II (surgical day care, SDC) stay
How fast is the recovery is-expressed in minutes
Measured: From end of surgical procedure to 24 hours after surgery
Opioid-related side effects
Risk of opioid-related side effects(nausea, vomiting, pruritis)
Measured: End of surgical procedure to 48 hours after surgery
Persistent post surgical pain DN4 screening tool
Satisfaction with pain management. Is prescribed pain medication enough?
Measured: 3 months post operatively
Block-related complications
bruising at injection site, numbness over lateral chest, weakness of shoulder or arm, pain/swelling at injection site
Measured: End of surgical procedure to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a prospective, double-blinded, randomised controlled trial conducted at Women's College Hospital. The study will enroll patients undergoing unilateral breast cancer surgery involving sentinel lymph node biopsy, axillary lymph node dissection and total axillary lymph node clearance. After obtaining written informed consent from eligible patients, study participants will be randomly assigned to one of two groups, the Erector spinae block group and the Control group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD,FRCPC, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978780
- Sponsor's protocol ID
- 2021-0048-B
- Status last verified
- Jul 2025
- First submitted
- 25 Mar 2019
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03978780
- Acronym / sponsor ID
- 2021-0048-B
- Keywords
- Spinae fascial plane block, Breast surgery, interfascial plane block, erector spinae block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Jun 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.
Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. It enhances multi-modal analgesia regimes while being opioid sparing, reducing incidence of post-operative nausea and vomiting and allowing earlier mobilisation/discharge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.
Detailed description
The ultrasound-guided erector spinae plane (ESP) block has been recently described for the successful management of thoracic neuropathic pain. The erector spinae muscle is formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anaesthetic in the fascial plane, deep to the erector spinae muscle, at the tip of the transverse process of the vertebra. Indirect access to the paravertebral space is gained providing analgesia without the risk of needle injury to structures in close proximity. Cadaveric studies have shown both ventral and dorsal rami of thoracic spinal nerves are affected when local anaesthetic is injected deep to the erector spinae muscle. The erector spinae muscle extends along the thoracolumbar spine allowing extensive cranio-caudal spread. The ventral ramus (intercostal nerve) is divided into the anterior and lateral branches. Its terminal branches provide the sensory innervation of the entire anterolateral wall. The dorsal ramus is divided into 2 terminal branches and it gives the sensory innervation to the posterior wall. Anterior spread of the local anaesthetic to the paravertebral space through the costotransverse foramina and the intertransverse complex provides both visceral and somatic analgesia.
While recent evidence supports statistically significant reductions in pain and opioid consumption among patients who receive an ESP block compared to systemic analgesia alone, the clinical significance of these differences are questionable the effect of ESP block on the patients' quality of recovery following ambulatory breast cancer surgery remains unclear.
Therefore, our objective is to determine whether or not the addition of an ESP block provides both superior analgesia and quality of recovery in patients undergoing ambulatory breast cancer surgery compared to systemic analgesia alone. We hypothesis that patients who received a preoperative ESP block will afford superior postoperative analgesia and improve the quality of recovery over the first 24 hours following surgery compared to those who receive a sham block for their ambulatory breast cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a prospective, double-blinded, randomised controlled trial conducted at Women's College Hospital. The study will enroll patients undergoing unilateral breast cancer surgery involving sentinel lymph node biopsy, axillary lymph node dissection and total axillary lymph node clearance. After obtaining written informed consent from eligible patients, study participants will be randomly assigned to one of two groups, the Erector spinae block group and the Control group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Procedure: Placebo BlockPatients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block (see above) under ultrasound guidance to stimulate a real block procedure. |
| Erector spinae plane (ESP) block group | Experimental | Procedure: Erector spinae plane blockLocal anaesthetic infiltration utilising 1% lidocaine will occur, and an 80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA classification: I-III
- BMI < 35 kg/m2
- Day surgery procedure
Key exclusion criteria (15 listed)
- Prior ipsilateral breast surgery, excluding lumpectomy
- Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
- Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases
- Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)
- Contraindication to regional anaesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)
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 block80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed. | Procedure or surgery | Erector spinae plane (ESP) block group |
| Placebo BlockPatients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block under ultrasound guidance to stimulate a real block procedure. | Procedure or surgery | Control Group |
Primary outcome
Acute postoperative pain at rest
Time frame: 24 hours postoperatively
Following breast surgery, measured as an area under the curve (AUC) of rest pain scores VAS scale where 0 corresponds to no pain, and 10 corresponds to worst pain imaginable
Quality of postoperative recovery (QoR 15)
Time frame: 24 hours post-surgery
Quality of recovery at 24 hours: questionnaire (0-10, where 0 = none of the time [poor] and 10 = all of the time [excellent])
7 secondary outcomes
Postoperative pain scores
Time frame: 0, 6, 12, 18, 24 and 48 hours post-operatively
Intraoperative opioid consumption
Time frame: During the procedure
Postoperative opioid consumption
Time frame: 12,24,48 hours, 7 days postoperative
Duration of phase I (PACU) and phase II (surgical day care, SDC) stay
Time frame: From end of surgical procedure to 24 hours after surgery
Opioid-related side effects
Time frame: End of surgical procedure to 48 hours after surgery
Persistent post surgical pain DN4 screening tool
Time frame: 3 months post operatively
Block-related complications
Time frame: End of surgical procedure to 48 hours after surgery
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 16 Jul 2025.
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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.
Richard Brull, MD,FRCPC principal investigator
Women's College Hospital
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 in people with Breast Cancer and Nerve Block, run by Women's College Hospital 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 3 inclusion and 15 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 16 Jul 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 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. Some participants in this study may receive a placebo. 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 Didem Bozak (416-323-6008, didem.bozak@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperative pain at rest (time frame: 24 hours postoperatively). 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?
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 16 Jul 2025.