Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

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

The aim of this study is to compare conventional and ultrasound guided paravertebral blocks to with respect to efficacy, patient satisfaction and complication rates.

Study Overview

• Status: Unknown
• Conditions: Mastectomy; Regional Anaesthesia; Breast-Conserving Surgery
• Intervention / Treatment: Procedure: Ultrasound guided paravertebral block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co. Galway
    • Galway, Co. Galway, Ireland
      • Recruiting
      • University Hospital Galway
      • Contact: Deirdre Nally, MCh; Phone Number: 00353860874690; Email: deirdrenally@rcsi.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Paravertebral Block; Patients receiving a conventional paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered using anatomical landmarks	Procedure: Ultrasound guided paravertebral block; 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.; Other Names: US paravertebral block
Active Comparator: Ultrasound Guided Paravertebral Block; Patients receiving paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered under ultrasound guidance	Procedure: Ultrasound guided paravertebral block; 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.; Other Names: US paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia requirements in 24 hours post op.	Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op	24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Measured on Visual Analogue Scale or Verbal Numerical Rating Scale at 1, 2 and 24 hours post operatively and 1 week	1, 2 and 24 hours post operatively and 1 week post operatively
Patient satisfaction	Satisfaction Questionnaire; SF 36 Questionnaire	Up to 2 weeks post operatively
Complications	Any complication of the procedure experienced	Up to 2 weeks post operatively

Collaborators and Investigators

• Sponsor: University College Hospital Galway

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: November 26, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: paravertebral block
• Other Study ID Numbers: UHG15