4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Erector Spinae Block vs. Placebo Block Study

Erector Spinae Block vs. Placebo Block Study

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Nerve Block Regional Anesthesia Neuromuscular Blockade Procedure: Erector spinae plane block Procedure: Placebo Block Not Applicable

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
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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.
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.

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.
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.

Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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])


Secondary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: 0, 6, 12, 18, 24 and 48 hours post-operatively ]
    VAS scale where 0 corresponds to no pain, and 10 corresponds to worst pain imaginable

  2. Intraoperative opioid consumption [ Time Frame: During the procedure ]
    Cumulative oral morphine equivalent after surgery

  3. Postoperative opioid consumption [ Time Frame: 12,24,48 hours, 7 days postoperative ]
    Cumulative oral morphine equivalent after surgery

  4. 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 ]
    How fast is the recovery is-expressed in minutes

  5. Opioid-related side effects [ Time Frame: End of surgical procedure to 48 hours after surgery ]
    Risk of opioid-related side effects(nausea, vomiting, pruritis)

  6. Persistent post surgical pain DN4 screening tool [ Time Frame: 3 months post operatively ]
    Satisfaction with pain management. Is prescribed pain medication enough?

  7. Block-related complications [ Time Frame: End of surgical procedure to 48 hours after surgery ]
    bruising at injection site, numbness over lateral chest, weakness of shoulder or arm, pain/swelling at injection site


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Didem Bozak 416-323-6008 didem.bozak@wchospital.ca

Locations
Layout table for location information
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   
Sponsors and Collaborators
Women's College Hospital
Investigators
Layout table for investigator information
Principal Investigator: Richard Brull, MD,FRCPC Women's College Hospital
Tracking Information
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
 (submitted: March 30, 2021)
  • 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])
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2021)
  • Postoperative pain scores [ Time Frame: 0, 6, 12, 18, 24 and 48 hours post-operatively ]
    VAS scale where 0 corresponds to no pain, and 10 corresponds to worst pain imaginable
  • Intraoperative opioid consumption [ Time Frame: During the procedure ]
    Cumulative oral morphine equivalent after surgery
  • Postoperative opioid consumption [ Time Frame: 12,24,48 hours, 7 days postoperative ]
    Cumulative oral morphine equivalent after surgery
  • 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 ]
    How fast is the recovery is-expressed in minutes
  • Opioid-related side effects [ Time Frame: End of surgical procedure to 48 hours after surgery ]
    Risk of opioid-related side effects(nausea, vomiting, pruritis)
  • Persistent post surgical pain DN4 screening tool [ Time Frame: 3 months post operatively ]
    Satisfaction with pain management. Is prescribed pain medication enough?
  • Block-related complications [ Time Frame: End of surgical procedure to 48 hours after surgery ]
    bruising at injection site, numbness over lateral chest, weakness of shoulder or arm, pain/swelling at injection site
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Sensory and motor block onset assesment-pinprick sensation test [ Time Frame: End of surgical procedure until 24 hours post-op ]
    Extent of dermatomal sensory block in the nerves involved will be performed
  • Mean opioid analgesic consumption [ Time Frame: 24 hours postoperative ]
    Cumulative oral morphine equivalent after surgery
  • Time to first analgesic request [ Time Frame: 24 hours postoperative ]
    The time when first patient need to take analgesic
  • Opioid-related side effects [ Time Frame: End of surgical procedure to 7 days following surgery ]
    Risk of opioid-related side effects(nausea, vomiting, pruritis)
  • Block-related complications [ Time Frame: End of surgical procedure to 7 days following surgery ]
    Presence/absence of block-related side effects such as bruising, infection, systemic toxicity, persistent numbness or shoulder weakness
  • Quality of recovery at 24 hours: questionnaire (0-10, where 0 = none of the time [poor] and 10 = all of the time [excellent]) [ Time Frame: Discharge from hospital until 24 hours post-op ]
    Completion of questionnaire (QoR) done by patient
  • Persistent post surgical pain [ Time Frame: 24 hours postoperative ]
    Satisfaction with pain management. Is prescribed pain medication enough?
  • Risk of chronic pain [ Time Frame: 3 months postoperatively. ]
    Simple question requiring a yes or no response. Tingling, numbness, pain.
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.

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
Condition  ICMJE
  • Breast Cancer
  • Nerve Block
  • Regional Anesthesia
  • Neuromuscular Blockade
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Placebo Block
  • 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.
    Intervention: Procedure: Erector spinae plane block
Publications *
  • 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.
  • Mazzinari G, Rovira L, Casasempere A, Ortega J, Cort L, Esparza-Miñana 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.
  • 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.
  • Gürkan Y, Aksu C, Kuş A, Yörükoğlu UH, Kılıç 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2021)
60
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Didem Bozak 416-323-6008 didem.bozak@wchospital.ca
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Richard Brull, MD,FRCPC Women's College Hospital
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

治疗医院