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Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

NCT ID: NCT02623387

Last Updated: 2015-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-06-30

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.

Conditions

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Regional Anaesthesia Mastectomy Breast-Conserving Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ultrasound guided paravertebral block

Intervention Type PROCEDURE

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.

Ultrasound Guided Paravertebral Block

Patients receiving paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered under ultrasound guidance

Group Type ACTIVE_COMPARATOR

Ultrasound guided paravertebral block

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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US paravertebral block

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University College Hospital Galway

OTHER

Sponsor Role lead

Responsible Party

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Deirdre Nally

Senior Registrar in General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Galway

Galway, Co. Galway, Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Deirdre Nally, MCh

Role: CONTACT

[email protected]

Facility Contacts

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Deirdre Nally, MCh

Role: primary

[email protected]
00353860874690

Other Identifiers

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UHG15

Identifier Type: -

Identifier Source: org_study_id