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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02741232 |
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Date of registration:
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13/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery
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Scientific title:
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Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02741232 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA 1 to 3 inclusively
- breast cancer surgery with or without axillary dissection
Exclusion Criteria:
- any contraindication to the pectoral nerve block (coagulopathy, infection, pre-
existing neuropathy, local anesthetic allergy and refusal of local anesthesia)
- refusal to participate in the study
- patient with dementia
- preoperative breast pain
- preoperative opioid consumption
- breast reconstructive surgery
- bilateral surgery
- pregnant patient
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Mastectomy
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Nerve Block
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Intervention(s)
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Drug: Lidocaine 1% with epinephrine 1/400000
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Other: sham block
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Primary Outcome(s)
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Intraoperative remifentanil consumption for the first 30 minutes of surgery
[Time Frame: 30 minutes]
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Secondary Outcome(s)
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Total intraoperative sevoflurane consumption
[Time Frame: 2 hours]
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Postoperative nausea and vomiting evaluation
[Time Frame: 30 minutes]
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Total intraoperative remifentanil consumption
[Time Frame: 2 hours]
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Postoperative pain evaluation
[Time Frame: 30 minutes]
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Postoperative opioid consumption
[Time Frame: 1 hour]
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Total time in the recovery room
[Time Frame: 60 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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