Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

Not Applicable

• Conditions: Breast-Conserving Surgery; Mastectomy; Regional Anaesthesia
• Interventions: Procedure: Ultrasound guided paravertebral block

• Registration Number: NCT02623387
• Lead Sponsor: University College Hospital Galway

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-11-26
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-04
• Last Update Submitted: 2015-12-04
• Study First Posted: 2015-12-07
• Last Update Posted: 2015-12-07
• Primary Completion: 2016-01
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Paravertebral Block	Ultrasound guided paravertebral block	Patients receiving paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered under ultrasound guidance
Standard Paravertebral Block	Ultrasound guided paravertebral block	Patients receiving a conventional paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered using anatomical landmarks

Primary Outcome Measures

Name	Time	Method
Analgesia requirements in 24 hours post op.	24hours	Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Galway; 🇮🇪 Galway, Co. Galway, Ireland