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Clinical Trials/NCT02623387
NCT02623387
Unknown
Not Applicable

A Prospective Randomized Controlled Trial of Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

University College Hospital Galway1 site in 1 country100 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Regional Anaesthesia
Sponsor
University College Hospital Galway
Enrollment
100
Locations
1
Primary Endpoint
Analgesia requirements in 24 hours post op.
Last Updated
10 years ago

Overview

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.

Detailed Description

Adequate pain control is important in breast cancer surgery. In addition to benefits to patients, effective pain management strategies also facilitate day case surgery. Regional anaesthetic techniques, and paravertebral blocks in particular, are valuable in this sphere. The conventional method of administering this block is blind and depends on anatomical landmarks for placement. Performing the block under US guidance provides real time imaging while advancing the needle. This might allow for a more accurate placement and hence a more effective block which would enhance pain relief and minimise complications.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
June 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University College Hospital Galway
Responsible Party
Principal Investigator
Principal Investigator

Deirdre Nally

Senior Registrar in General Surgery

University College Hospital Galway

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing resectional breast surgery
  • Benign or malignant indications for surgery

Exclusion Criteria

  • Previous spinal surgery
  • Severe coagulopathy
  • Allergies to local anaesthesia
  • Localised infection at site of injection

Outcomes

Primary Outcomes

Analgesia requirements in 24 hours post op.

Time Frame: 24hours

Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op

Secondary Outcomes

  • Pain Scores(1, 2 and 24 hours post operatively and 1 week post operatively)
  • Complications(Up to 2 weeks post operatively)
  • Patient satisfaction(Up to 2 weeks post operatively)

Study Sites (1)

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