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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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16 December 2017 |
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Main ID: |
NCT03024697 |
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Date of registration:
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15/01/2017 |
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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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Single-shot Pectoral Plane(PECs) Block Versus Continuous Local Anaesthetic Infusion Analgesia or Both PECS Block and Local Anaesthetic Infusion After Breast Surgery: A Prospective Randomised, Double-blind Trial
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Scientific title:
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Single-shot Pectoral Plane (PECs) Blocks Versus Continuous Local Anaesthetic Infusion Analgesia or Both PECs Block and Local Anaesthetic Infusion After Non-ambulatory Breast Cancer Surgery: A Prospective, Randomised, Double-blind Trial |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03024697 |
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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: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Donal Buggy |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mater Misericordiae University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female
- Undergoing breast surgery, including wide local excision (WLE) and sentinel lymph node
biopsy (SLNB), mastectomy +- SLNB
Exclusion Criteria:
- Male
- Undergoing flap reconstruction breast surgery, implant surgery or bilateral breast
surgery
- Chronic pain syndrome
- Local anaesthetic allergy
- Contraindication to routine postoperative analgesia, e.g. paracetamol
- Contraindication to regional anaesthesia, i.e. localised infection
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anesthesia
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Breast Diseases
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Block
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Intervention(s)
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Procedure: Local Anaesthetic Wound Infusion Catheter
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Procedure: Pectoral Plane Block
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Primary Outcome(s)
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Area under curve of verbal rating score (VRS) of pain moving versus time
[Time Frame: VRS pain was measured at 1 hour, 4-6 hours, 10-14 hours, and 20-24 hours postoperatively]
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Secondary Outcome(s)
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Total postoperative opioid consumption
[Time Frame: Over first 24 postoperative hours]
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Postoperative sedation score
[Time Frame: Recorded at the following time points after surgery: 1 hour, 2-4 hours, 6-8 hours, 10-14 hours 20-24 hours]
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Postoperative nausea and vomiting
[Time Frame: Recorded at the following time points after surgery: 1 hour, 2-4 hours, 6-8 hours, 10-14 hours 20-24 hours]
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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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