Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
48 participants
INTERVENTIONAL
2019-12-01
2024-01-01
Brief Summary
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Detailed Description
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The PECS block is a recognized effective anaesthetic technique used for both intraoperative and postoperative pain control in adult breast surgery, chest wall procedures as well as one case report for CIED implantation and a small series in paediatric cardiac surgery. The advantages of the PECS block in these surgical procedures includes improved analgesia and reduced opioid use.
The investigators plan to conduct an RCT with two groups.
Group 1 will receive a PECS block (using 0.8 ml/kg of 0.25% bupivacaine with epinephrine 1: 200000 divided in two equal volumes between the two planes) by the anaesthesiologist and local infiltration (up to 0.2 ml/kg of 0.25% bupivacaine with epinephrine 1:200000) by the surgeon.
Group 2 will receive local infiltration (up to 0.8 ml/kg 0.25 % bupivacaine with epinephrine 1:200000) by the surgeon alone.
Both groups will be given opioids as rescue analgesics as deemed necessary during their procedure and as rescue analgesia postoperatively, so that no patient will have untreated pain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PECS block
A PECS block of 0.25 % bupivacaine with epinephrine 1:200000 (below the toxic dose limit of 3 mg/kg) in divided doses to cover the fascial planes identified in PECS I and PECS II. At the completion of surgery, the wound will be infiltrated with up to 0.2 ml/kg of 0.25 % bupivacaine into the wound.
Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration
The anesthesiologist will administer bupivacaine 0.25% with epinephrine 1:200000 by PECS block after induction of anesthesia before surgical incision. The EP cardiologist will also administer bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
Infiltration
At the completion of surgery, the EP cardiologist will infiltrate the wound with up to 0.8 ml/kg of 0.25 % bupivacaine with epinephrine 1:200000.
Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only
The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
Interventions
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Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration
The anesthesiologist will administer bupivacaine 0.25% with epinephrine 1:200000 by PECS block after induction of anesthesia before surgical incision. The EP cardiologist will also administer bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only
The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* No parental or patient consent
* Allergy to bupivacaine
* Pregnancy or lactation
* Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
3 Years
18 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Katherine Taylor
Associate Professor
Principal Investigators
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Katherine Taylor
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Froyshteter AB, Bhalla T, Tobias JD, Cambier GS, Mckee CT. Pectoralis blocks for insertion of an implantable cardioverter defibrillator in two patients with Duchenne muscular dystrophy. Saudi J Anaesth. 2018 Apr-Jun;12(2):324-327. doi: 10.4103/sja.SJA_624_17.
Fujiwara A, Komasawa N, Minami T. Pectoral nerves (PECS) and intercostal nerve block for cardiac resynchronization therapy device implantation. Springerplus. 2014 Aug 5;3:409. doi: 10.1186/2193-1801-3-409. eCollection 2014.
Al Ja'bari A, Robertson M, El-Boghdadly K, Albrecht E. A randomised controlled trial of the pectoral nerves-2 (PECS-2) block for radical mastectomy. Anaesthesia. 2019 Oct;74(10):1277-1281. doi: 10.1111/anae.14769. Epub 2019 Jul 4.
Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
Amir A, Jolin S, Amberg S, Nordstrom S. Implementation of Pecs I and Pecs II Blocks as Part of Opioid-Sparing Approach to Breast Surgery. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):544-5. doi: 10.1097/AAP.0000000000000401. No abstract available.
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
Kumar KN, Kalyane RN, Singh NG, Nagaraja PS, Krishna M, Babu B, Varadaraju R, Sathish N, Manjunatha N. Efficacy of bilateral pectoralis nerve block for ultrafast tracking and postoperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):333-338. doi: 10.4103/aca.ACA_15_18.
Other Identifiers
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1000065122
Identifier Type: -
Identifier Source: org_study_id
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