Regional AnaesthesiaNCT02623387
Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery
A study testing Ultrasound guided paravertebral block in people with Regional Anaesthesia and Mastectomy, run by University College Hospital Galway at 1 site in Ireland.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Regional Anaesthesia, Mastectomy, Breast-Conserving Surgery
- What is being tested?
- Ultrasound guided paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing resectional breast surgery
- Benign or malignant indications for surgery
Who cannot join
- Previous spinal surgery
- Severe coagulopathy
- Allergies to local anaesthesia
- Localised infection at site of injection
Trial locations and contacts
1 site in 1 country.
Deirdre Nally, MCh contact
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Galway
Galway, Co. Galway
Deirdre Nally, MCh, 00353860874690, deirdrenally@rcsi.ie
About this study
Official title: 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.
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.
- Conditions
- Regional Anaesthesia, Mastectomy, Breast-Conserving Surgery
- Being tested
- Ultrasound guided paravertebral block
- Keywords
- paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided paravertebral blockProcedure or surgery
Also called US 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Paravertebral Block | Active comparator | Patients receiving a conventional paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered using anatomical landmarks Receives: Procedure: Ultrasound guided paravertebral block |
| Ultrasound Guided Paravertebral Block | Active comparator | Patients receiving paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered under ultrasound guidance Receives: Procedure: Ultrasound guided paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia requirements in 24 hours post op.
Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op
Measured: 24hours
Secondary outcomes (3)
Pain Scores
Measured on Visual Analogue Scale or Verbal Numerical Rating Scale at 1, 2 and 24 hours post operatively and 1 week
Measured: 1, 2 and 24 hours post operatively and 1 week post operatively
Patient satisfaction
- Satisfaction Questionnaire
- SF 36 Questionnaire
Measured: Up to 2 weeks post operatively
Complications
Any complication of the procedure experienced
Measured: Up to 2 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deirdre Nally, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623387
- Sponsor's protocol ID
- UHG15
- Status last verified
- Dec 2015
- First submitted
- 26 Nov 2015
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery
- ClinicalTrials.gov ID
- NCT02623387
- Acronym / sponsor ID
- UHG15
- Conditions
- Regional Anaesthesia, Mastectomy, Breast-Conserving Surgery
- Keywords
- paravertebral block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Paravertebral Block | Active comparator | Procedure: Ultrasound guided paravertebral blockPatients receiving a conventional paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered using anatomical landmarks |
| Ultrasound Guided Paravertebral Block | Active comparator | Procedure: Ultrasound guided paravertebral blockPatients receiving paravertebral block of dilute local anaesthetic (eg. 5ml of 0.5% bupivacaine or similar) administered under ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing resectional breast surgery
- Benign or malignant indications for surgery
Key exclusion criteria (4 listed)
- Previous spinal surgery
- Severe coagulopathy
- Allergies to local anaesthesia
- Localised infection at site of injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided paravertebral blockAlso: US paravertebral blockParavertebral 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. | Procedure or surgery | Standard Paravertebral Block, Ultrasound Guided Paravertebral Block |
Primary outcome
Analgesia requirements in 24 hours post op.
Time frame: 24hours
Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op
3 secondary outcomes
Pain Scores
Time frame: 1, 2 and 24 hours post operatively and 1 week post operatively
Patient satisfaction
Time frame: Up to 2 weeks post operatively
Complications
Time frame: Up to 2 weeks post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deirdre Nally, MCh contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided paravertebral block in people with Regional Anaesthesia and Mastectomy, run by University College Hospital Galway at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deirdre Nally, MCh (deirdrenally@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia requirements in 24 hours post op. (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.