Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Nerve Block Regional Anesthesia Neuromuscular Blockade | Procedure: Erector spinae plane block Procedure: Placebo Block | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
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. |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Blinded for patient, assessor, anesthesiologist in the operating room |
Primary Purpose: | Treatment |
Official Title: | Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled Trial |
Estimated Study Start Date : | May 3, 2021 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | August 2023 |
Arm | Intervention/treatment |
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Placebo Comparator: Control Group
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.
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Procedure: 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.
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Experimental: Erector spinae plane (ESP) block group
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.
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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.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Didem Bozak | 416-323-6008 | didem.bozak@wchospital.ca |
Canada, Ontario | |
Women's College Hospital | |
Toronto, Ontario, Canada, M5S 1B2 | |
Contact: Richard Brull, MD 416-323-6400 ext 4239 richard.brull@wchospital.ca | |
Contact: Didem Bozak 416-323-6400 ext 6008 didem.bozak@wchospital.ca |
Principal Investigator: | Richard Brull, MD,FRCPC | Women's College Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | March 25, 2019 | ||||
First Posted Date ICMJE | June 7, 2019 | ||||
Last Update Posted Date | April 2, 2021 | ||||
Estimated Study Start Date ICMJE | May 3, 2021 | ||||
Estimated Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Post-operative pain scores [ Time Frame: 24 hours postoperative ] The patient's level of pain in the postoperative period will be evaluated by the use of a Visual Analogue Scale (VAS).Range between 0-10.The mean of these scores at the 4 different time points will be calculated.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Erector Spinae Block vs. Placebo Block Study | ||||
Official Title ICMJE | Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled Trial | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment 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. Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Blinded for patient, assessor, anesthesiologist in the operating room Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE |
130 | ||||
Estimated Study Completion Date ICMJE | August 2023 | ||||
Estimated Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03978780 | ||||
Other Study ID Numbers ICMJE | 2020-0052-B | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Women's College Hospital | ||||
Study Sponsor ICMJE | Women's College Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Women's College Hospital | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |