ClinicalTrials.gg
Status unknownNCT02623387Updated Dec 7, 2015

Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

An interventional study of Ultrasound guided paravertebral block in Regional Anaesthesia, Mastectomy and Breast-Conserving Surgery, sponsored by University College Hospital Galway. Status unknown at 1 site in Ireland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-07.

Sponsored by University College Hospital Galway · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Regional Anaesthesia
  • Mastectomy
  • Breast-Conserving Surgery

Keywords

  • paravertebral block
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In context

Lead sponsor

University College Hospital Galway is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureUltrasound 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.

    Also known as: US paravertebral block

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What researchers measure

Primary outcomes

  1. Analgesia requirements in 24 hours post op.

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

    Time frame: 24hours

Secondary outcomes

  1. Pain Scores

    Measured on Visual Analogue Scale or Verbal Numerical Rating Scale at 1, 2 and 24 hours post operatively and 1 week

    Time frame: 1, 2 and 24 hours post operatively and 1 week post operatively

  2. Patient satisfaction

    1. Satisfaction Questionnaire 2. SF 36 Questionnaire

    Time frame: Up to 2 weeks post operatively

  3. Complications

    Any complication of the procedure experienced

    Time frame: Up to 2 weeks post operatively

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Study locations

1 of 1 sites recruiting
  • University Hospital Galway
    Galway, Co. Galway, Ireland
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02623387
Lead sponsor
University College Hospital Galway
Responsible party
Deirdre Nally (Senior Registrar in General Surgery, University College Hospital Galway) — Principal investigator
First posted
Dec 7, 2015
Start date
Jun 2015
Primary completion
Jan 2016 (estimated)
Completion
Jun 2016 (estimated)
Last update
Dec 7, 2015

Study contacts

Deirdre Nally, MCh
Contact
deirdrenally@rcsi.ie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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