Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Regional Anaesthesia, Mastectomy, Breast-Conserving Surgery

Intervention / Treatment
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* Procedure: Ultrasound guided paravertebral block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Paravertebral Block<br>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<br>* 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.<br>* Other names: US paravertebral block;|
| Active Comparator: Ultrasound Guided Paravertebral Block<br>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<br>* 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.<br>* Other names: US paravertebral block;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paravertebral block