Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Serratus vs. Erector Spinae Fascial Plane Block for Breast and Axillary Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03978780
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Women's College Hospital

Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date October 6, 2020
Estimated Study Start Date  ICMJE January 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
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.(0, 6 , 12, and 24 hours postoperatively)
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: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serratus vs. Erector Spinae Fascial Plane Block for Breast and Axillary Surgery
Official Title  ICMJE The Ideal Analgesic Technique for Breast Cancer Surgery Involving the Axilla: A Randomized Comparison Between the Serratus and Erector Spinae Fascial Plane Blocks
Brief Summary Both serratus plane and erector spinae fascial plane blocks are described to produce local anesthetic spread to the nerves innervating the axilla. Investigators think that the serratus plane block is more reliable for blocking axillary innervation. Investigators hypothesized that the serratus plane block provides superior postoperative analgesia for breast surgery involving the axilla.
Detailed Description The serratus anterior block provides postoperative analgesia for breast and axillary surgery. The axilla is an anatomical area with complex innervation and significant contribution to postoperative pain. Injection of local anesthetics in the serratus muscle fascial plane results in blocking the intercostal nerves T2-T6 that innervate the breast, as well as the long thoracic, thoracodorsal and medial and lateral pectoral nerves, which innervate the axilla. Recently, the erector spinae plane block has been described. The block has been proposed as an effective and reliable technique for blocking the innervation of the breast, as well as the brachial plexus rami that innervate the axilla. As such, both blocks purportedly provide pain relief to the axilla. Investigators aimed to compare these two blocks to identify the technique that provides superior postoperative analgesia for breast surgeries involving the axilla.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, parallel group, blinded for patient, assessor, anesthesiologist in the operating room
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Nerve Block
  • Regional Anesthesia
  • Neuromuscular Blockade
Intervention  ICMJE
  • Procedure: Serratus Block
    50-90mm mm 22G insulated block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the serratus muscle.
  • 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 T3 transverse process.
Study Arms  ICMJE
  • Experimental: Serratus Plane Block

    The target fascial plane superficial to the serratus anterior (superficial) muscle will be identified and the path of the block needle will be determined. After local anaesthetic infiltration of the skin with 1% lidocaine, a 50-90mm mm 22G insulated block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the serratus muscle. Once the tip is verified in the correct position, 0.4 ml/kg (max. 30 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.

    In patients randomised to the serratus plane block group, using ultrasound guidance a sham subcutaneous injection of 0.5ml sterile normal saline injection will be performed at the same site of the ESP block to stimulate a real block procedure.

    Intervention: Procedure: Serratus Block
  • Experimental: Erector spinae plane block
    The interfascial plane deep to the erector spinae muscle will be identified and the path of the needle determined. The path of the needle will be visualised to target the area between the erector spinae muscle and the T3 transverse process. 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 T3 transverse process. Once the needle tip is in the correct position, 0.4 ml/kg (max. 30 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. After injection, patients will be closely monitored until they are transferred to the OR.
    Intervention: Procedure: Erector spinae plane block
Publications *

*   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 6, 2020)
70
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
130
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ASA classification I-III
  2. BMI < 35 kg/m2
  3. Having outpatient unilateral breast cancer surgery that involves the axilla.

Exclusion Criteria:

  1. Prior ipsilateral breast surgery, excluding lumpectomy.
  2. Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
  3. Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases
  4. Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)
  5. Contraindication to regional anaesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)
  6. Patient refusal
  7. Chronic pain disorder
  8. Chronic opioid use (≥30 mg oxycodone / day)
  9. Contraindication (or allergy) to a component of multi-modal analgesia protocol
  10. Allergy to amide local anaesthetics used in nerve blocks
  11. Contraindications to any of the components of the standardized general anaesthesia
  12. Significant psychiatric disorder that would preclude objective study assessment
  13. Pregnancy
  14. 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 Serratus vs. ESP block
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 October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP