Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery
A Prospective Randomized Controlled Trial of Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery
1 other identifier
interventional
100
1 country
1
Brief Summary
The aim of this study is to compare conventional and ultrasound guided paravertebral blocks to with respect to efficacy, patient satisfaction and complication rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 26, 2015
CompletedFirst Posted
Study publicly available on registry
December 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedDecember 7, 2015
December 1, 2015
7 months
November 26, 2015
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analgesia requirements in 24 hours post op.
Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op
24hours
Secondary Outcomes (3)
Pain Scores
1, 2 and 24 hours post operatively and 1 week post operatively
Patient satisfaction
Up to 2 weeks post operatively
Complications
Up to 2 weeks post operatively
Study Arms (2)
Standard Paravertebral Block
ACTIVE COMPARATORPatients receiving a conventional paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered using anatomical landmarks
Ultrasound Guided Paravertebral Block
ACTIVE COMPARATORPatients receiving paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered under ultrasound guidance
Interventions
Paravertebral blocks is a regional anaesthetic technique in which thoracic spinal nerves are inhibited for post operative analgesia in patients undergoing breast surgery. The site of injection can be determined using anatomical landmarks (standard) or using ultrasound guidance.
Eligibility Criteria
You may qualify if:
- Patients undergoing resectional breast surgery
- Benign or malignant indications for surgery
You may not qualify if:
- Previous spinal surgery
- Severe coagulopathy
- Allergies to local anaesthesia
- Localised infection at site of injection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Galway
Galway, Co. Galway, Ireland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Registrar in General Surgery
Study Record Dates
First Submitted
November 26, 2015
First Posted
December 7, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Study Completion
June 1, 2016
Last Updated
December 7, 2015
Record last verified: 2015-12