Clinical trial NCT03978780: Erector Spinae Block vs. Placebo Block Study
Official title: Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Nerve Block
Regional Anesthesia
Neuromuscular Blockade
Keywords: Spinae fascial plane block
Breast surgery
interfascial plane block
erector spinae block
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acute postoperative pain at rest
timeFrame: 24 hours postoperatively
measure: Quality of postoperative recovery (QoR 15)
timeFrame: 24 hours post-surgery
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: 0, 6, 12, 18, 24 and 48 hours post-operatively
measure: Intraoperative opioid consumption
timeFrame: During the procedure
measure: Postoperative opioid consumption
timeFrame: 12,24,48 hours, 7 days postoperative
measure: Duration of phase I (PACU) and phase II (surgical day care, SDC) stay
timeFrame: From end of surgical procedure to 24 hours after surgery
measure: Opioid-related side effects
timeFrame: End of surgical procedure to 48 hours after surgery
measure: Persistent post surgical pain DN4 screening tool
timeFrame: 3 months post operatively
measure: Block-related complications
timeFrame: End of surgical procedure to 48 hours after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Richard Brull, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: