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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 : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Women's College Hospital

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Official Title: The Ideal Analgesic Technique for Breast Cancer Surgery Involving the Axilla: A Randomized Comparison Between the Serratus and Erector Spinae Fascial Plane Blocks
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.

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.
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Mean opioid analgesic consumption [ Time Frame: 24 hours postoperative ]
    cumulative oral morphine equivalent after surgery

  3. Time to first analgesic request [ Time Frame: 24 hours postoperative ]
    The time when first patient need to take analgesic

  4. Opioid-related side effects [ Time Frame: End of surgical procedure to 7 days following surgery ]
    Risk of opioid-related side effects(nausea, vomiting, pruritis)

  5. 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

  6. 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

  7. Persistent post surgical pain [ Time Frame: 24 hours postoperative ]
    Satisfaction with pain management. Is prescribed pain medication enough?

  8. Risk of chronic pain [ Time Frame: 3 months postoperatively. ]
    Simple question requiring a yes or no response. Tingling, numbness, pain.



Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978780


Contacts
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Contact: Didem Bozak 416-323-6008 didem.bozak@wchospital.ca

Locations
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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
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Principal Investigator: Richard Brull, MD,FRCPC Women's College Hospital
Publications:
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Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT03978780    
Other Study ID Numbers: Serratus vs. ESP block
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women's College Hospital:
Spinae fascial plane block
Serratus plane block
Breast surgery
interfascial plane block
erector spinae block
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases