Anesthesia, ConductionNCT04928794

Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy

A study testing Erector Spinae Plane Block and Paravertebral Block in people with Anesthesia, Conduction, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Anesthesia, Conduction
What is being tested?: Erector Spinae Plane Block and Paravertebral Block
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 19 May 2021to 23 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Adult female patients having bilateral mastectomy surgery at University of New Mexico Outpatient Surgical and Imaging Services (OSIS) facility
Age >18 years
Consenting to regional anesthesia for postoperative pain control

Who cannot join

Age <18 years
Unable to consent
Using anticoagulant medication or have a bleeding disorder
Pregnancy
Inability to speak English for consent process

Trial locations and contacts

1 site in 1 country.

United States1 site

University of New Mexico Outpatient Surgical and Imaging Services
Albuquerque, New Mexico, 87102

Other trials in United States

About this study

Official title: Dermatomal Spread of Paravertebral and Erector Spinae Plane Nerve Blocks as Compared by Thermal Imaging

This is a one-armed trial of two regional anesthesia (peripheral nerve block) techniques to provide postoperative analgesia after bilateral mastectomy. The two techniques are paravertebral block and erector spinae plane (ESP) block. Patients will serve as their own controls, with one block technique applied on one side of the body and the other technique contralaterally. Anatomical distribution of block effectiveness will be assessed with thermal imaging, and this distribution will be visually compared between the two techniques.

Conditions: Anesthesia, Conduction
Being tested: Erector Spinae Plane Block, Paravertebral Block
Keywords: Paravertebral nerve block, Erector Spinae Plane block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Erector Spinae Plane BlockProcedure or surgery
Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles
Paravertebral BlockProcedure or surgery
Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae

Study groups in NCT04928794
Study group	Role	What they receive
Peripheral Nerve Block with 2 Techniques	Other	Not described Receives: Procedure: Erector Spinae Plane Block; Procedure: Paravertebral Block

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin Temperature Increase From Baseline
Thermography-measured increase in temperature of skin affected by nerve block
Measured: 30 minutes

Secondary outcomes (1)

Average Skin Temperature
Thermography-measured temperature of skin affected by nerve block
Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 202123 Aug 2021

First posted16 Jun 2021
Study start19 May 2021
Primary completion23 Aug 2021
Study completion23 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anesthesia, ConductionStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04928794
Sponsor's protocol ID: 21-104 Billstrand
Status last verified: Oct 2024
First submitted: 26 May 2021
Last updated: 21 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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All Anesthesia, Conduction trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dermatomal Spread of Paravertebral and Erector Spinae Plane Nerve Blocks as Compared by Thermal Imaging
ClinicalTrials.gov ID: NCT04928794
Acronym / sponsor ID: 21-104 Billstrand
Conditions: Anesthesia, Conduction
Keywords: Paravertebral nerve block, Erector Spinae Plane block
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of New MexicoUniversity, hospital or other
Study start: 19 May 2021 (actual)
Primary completion: 23 Aug 2021 (actual)
Study completion: 23 Aug 2021 (actual)
First posted: 16 Jun 2021 (actual)
Results: Posted 21 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Peripheral Nerve Block with 2 Techniques	Other	Procedure: Erector Spinae Plane Block, Procedure: Paravertebral Block

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult female patients having bilateral mastectomy surgery at University of New Mexico Outpatient Surgical and Imaging Services (OSIS) facility
Age >18 years
Consenting to regional anesthesia for postoperative pain control

Key exclusion criteria (5 listed)

Age <18 years
Unable to consent
Using anticoagulant medication or have a bleeding disorder
Pregnancy
Inability to speak English for consent process

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
Erector Spinae Plane BlockRegional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles	Procedure or surgery	Peripheral Nerve Block with 2 Techniques
Paravertebral BlockRegional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae	Procedure or surgery	Peripheral Nerve Block with 2 Techniques

Primary outcome

Skin Temperature Increase From Baseline
Time frame: 30 minutes
Thermography-measured increase in temperature of skin affected by nerve block

1 secondary outcome

Average Skin Temperature
Time frame: 30 minutes

Results and safety

Results posted to the registry on 21 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erector Spinae Plane Block	8	8
Paravertebral Block	8	8

Primary outcome: Skin Temperature Increase From Baseline

Time frame: 30 minutes. Mean (Standard Deviation). Unit: degrees C

Measure	Erector Spinae Plane Block Side n = 8	Paravertebral Block Side n = 8
Value	1.9 (0.8)	2.3 (0.9)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: One day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erector Spinae Plane Block	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Paravertebral Block	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Anesthesia, Conduction

Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
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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.

Mary Billstrand, MD principal investigator

University of New Mexico

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane Block and Paravertebral Block in people with Anesthesia, Conduction, run by University of New Mexico at 1 site in United States.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 21 Oct 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin Temperature Increase From Baseline (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04928794.

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 21 Oct 2024.