Erector Spinae Block vs. Placebo Block Study

NCT03978780 | Not Yet Recruiting

• 1 other identifier: 2021-0048-B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer; Nerve Block; Regional Anesthesia; Neuromuscular Blockade

Keywords

Spinae fascial plane block; Breast surgery; interfascial plane block; erector spinae block

Outcome Measures

Primary Outcomes (2)

• 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

  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 \[excellent\])

  24 hours post-surgery

Secondary Outcomes (7)

• Postoperative pain scores

  0, 6, 12, 18, 24 and 48 hours post-operatively

• Intraoperative opioid consumption

  During the procedure

• Postoperative opioid consumption

  12,24,48 hours, 7 days postoperative

• Duration of phase I (PACU) and phase II (surgical day care, SDC) stay

  From end of surgical procedure to 24 hours after surgery

• Opioid-related side effects

  End of surgical procedure to 48 hours after surgery

Study Arms (2)

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.

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.

Procedure: Erector spinae plane block

Interventions

Erector spinae plane block PROCEDURE

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.

Erector spinae plane (ESP) block group

Placebo Block PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA classification: I-III
• BMI \< 35 kg/m2
• Day surgery procedure

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard Brull, MD,FRCPC

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didem Bozak

CONTACT

416-323-6008; didem.bozak@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded for patient, assessor, anesthesiologist in the operating room
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: June 7, 2019
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

CA (1)