Erector Spinae Block vs. Placebo Block Study

Breast Cancer Clinical Trial

Official title:

Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03978780
• Other study ID #: 2021-0048-B
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Women's College Hospital
• Contact: Didem Bozak
• Phone: 416-323-6008
• Email: didem.bozak[@]wchospital.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Nerve Block
• Neuromuscular Blockade
• Regional Anesthesia

Intervention

Procedure:
• Erector spinae plane block
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 Block
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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. — View Citation

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2. — View Citation

Mazzinari G, Rovira L, Casasempere A, Ortega J, Cort L, Esparza-Minana JM, Belaouchi M. Interfascial block at the serratus muscle plane versus conventional analgesia in breast surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):52-58. doi: 10.1136/rapm-2018-000004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Postoperative pain scores	VAS scale where 0 corresponds to no pain, and 10 corresponds to worst pain imaginable	0, 6, 12, 18, 24 and 48 hours post-operatively
Secondary	Intraoperative opioid consumption	Cumulative oral morphine equivalent after surgery	During the procedure
Secondary	Postoperative opioid consumption	Cumulative oral morphine equivalent after surgery	12,24,48 hours, 7 days postoperative
Secondary	Duration of phase I (PACU) and phase II (surgical day care, SDC) stay	How fast is the recovery is-expressed in minutes	From end of surgical procedure to 24 hours after surgery
Secondary	Opioid-related side effects	Risk of opioid-related side effects(nausea, vomiting, pruritis)	End of surgical procedure to 48 hours after surgery
Secondary	Persistent post surgical pain DN4 screening tool	Satisfaction with pain management. Is prescribed pain medication enough?	3 months post operatively
Secondary	Block-related complications	bruising at injection site, numbness over lateral chest, weakness of shoulder or arm, pain/swelling at injection site	End of surgical procedure to 48 hours after surgery