Serratus vs. Erector Spinae Fascial Plane Block for Breast and Axillary Surgery
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|ClinicalTrials.gov Identifier: NCT03978780|
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Nerve Block Regional Anesthesia Neuromuscular Blockade||Procedure: Serratus Block Procedure: Erector spinae plane block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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)|
|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|
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.
- 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)
- 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.
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
|Contact: Didem Bozakemail@example.com|
|Principal Investigator:||Richard Brull, MD,FRCPC||Women's College Hospital|