[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100360872":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Women's College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","PLACEBO_COMPARATOR","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.",[13],"Procedure: Placebo Block",{"label":15,"type":16,"description":17,"interventionNames":18},"Erector spinae plane (ESP) block group","EXPERIMENTAL","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.",[19],"Procedure: Erector spinae plane block",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[9],[32],{"name":33,"affiliation":5,"role":34},"Richard Brull, MD,FRCPC","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Didem Bozak","CONTACT","416-323-6008","didem.bozak@wchospital.ca",[42],{"facility":5,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Toronto","Ontario","M5S 1B2","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-79.39864,43.70643,{"lat":52,"lon":51},[55,60],{"name":56,"role":38,"phone":57,"phoneExt":58,"email":59},"Richard Brull, MD","416-323-6400","4239","richard.brull@wchospital.ca",{"name":37,"role":38,"phone":57,"phoneExt":61,"email":40},"6008",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100360872","erector-spinae-block-vs-placebo-block-study-100360872",false,"NCT03978780","Erector Spinae Block vs. Placebo Block Study","Quality of Recovery Scores Following Erector Spinae Block vs. Sham Block in Ambulatory Breast Cancer Surgery: A Randomised Controlled Trial","Inclusion Criteria:\n\n* ASA classification: I-III\n* BMI \\\u003C 35 kg\u002Fm2\n* Day surgery procedure\n\nExclusion Criteria:\n\n* Prior ipsilateral breast surgery, excluding lumpectomy\n* Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest\n* Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases\n* Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe \u002F poorly controlled asthma)\n* Contraindication to regional anaesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)\n* Patient refusal\n* Chronic pain disorder\n* Chronic opioid use (≥30 mg oxycodone \u002F day)\n* Contraindication (or allergy) to a component of multi-modal analgesia protocol\n* Allergy to amide local anaesthetics used in nerve blocks\n* Contraindications to any of the components of the standardized general anaesthesia\n* Significant psychiatric disorder that would preclude objective study assessment\n* Pregnancy\u002F women with nursing infants\n* Unable to provide informed consent\n* Unable to speak and read English","ALL","18 Years","65 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"NA","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\u002Fdischarge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.",[82,83,84,85],"Breast Cancer","Nerve Block","Regional Anesthesia","Neuromuscular Blockade",[87,88,89,90],"Spinae fascial plane block","Breast surgery","interfascial plane block","erector spinae block","NOT_YET_RECRUITING","2025-07-14",{"date":94,"type":95},"2025-07-16","ACTUAL",{"date":97,"type":76},"2026-06",{"date":99,"type":76},"2028-01",{"name":5,"class":6},1]