Pain, ChronicNCT03831581
Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
A study testing Erector Spinae Plane Block in people with Pain, Chronic and Pain, Postoperative, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Chronic, Pain, Postoperative
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2018to 31 Oct 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years, in the acute / chronic pain service that presents pain in the thoracic region and / or upper hemiabdomen.
Who cannot join
- Women in pregnancy
- Patients with less than 50 Kg of weight
- Dissent of informed consent
Trial locations and contacts
1 site in 1 country.
Colombia1 site
hospital universitario San Vicente Fundacion
Medellín, Antioquia
About this study
Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block
Read the detailed description
Interventional study that evaluate dermatomal distribution with pinprick and cold, and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5% at the thoracic level in patients with pain in the thorax and upper abdomen.
- Conditions
- Pain, Chronic, Pain, Postoperative
- Being tested
- Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane, Erector Spinae Plane Block
- Medical subject headings
- Chronic Pain, Pain, Postoperative
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
In patients with chest pain, ultrasound-guided Erector Spinae Plane Block block was performed at T5 transverse process in the cephalo-caudal direction with Tuohy 18 gauge needle in plane until the needle tip was located in the interfascial plane between the transverse process and the erector spinae muscles, 20 ml of bupivacaine 0.5% was administered and a catheter was inserted if indicated.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Patients with chest pain or upper abdomen underwent Erector Spinae Plane Block guided by ultrasound, bupivacaine 0.5% 20 ml was administered in the interfascial plane between the transverse process of T5 and the erector muscles of the spine, 60 minutes after dermatomes distribution was evaluated with pinprick and cold. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatomes with sensitive block
Number (average) of dermatomes with sensitive block with pinprick and cold achieved at 60 minutes after the Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5%. Also, observe the distribution pattern.
Measured: 60 minutes
Secondary outcomes (7)
weight
weight in kilograms and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Measured: 60 minutes
Adverse events
Frequency of adverse events (hypotension, pneumothorax, neurological deficit, bradycardia) after the Erector Spinae Plane (ESP) block.
Measured: 60 minutes and 24 hours
Success rate
Success rate (Blocking of at least 2 continuous dermatomes at the puncture site measured with pinprick and cold)
Measured: 60 minutes and 24 hours
Degree of satisfaction
Degree of satisfaction evaluated with the Likert scale of 4 points (1 dissatisfied, 2 slightly dissatisfied, 3 slightly satisfied, 4 satisfied).
Measured: 60 minutes and 24 hours
Visual Analogue Scale (VAS)
Change From Baseline in Pain Scores on the Visual analogue scale (VAS) from 1 to 10 at 60 minutes and 24 hours after the ESP block.
Measured: 60 minutes and 24 hours
Height
Height in meters and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Measured: 60 minutes
Age
Age in years and its correlation with the main result The variables were grouped in means (standard deviation) for continuous variables and frequencies (percentages) for categorical variables.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Jan 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies 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
- Model description
- Assignment interventional
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Cadavid, Study chair, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831581
- Sponsor's protocol ID
- UdeA1003
- Status last verified
- Nov 2018
- First submitted
- 14 Jan 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only final results of research
Publications
Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.
PubMed 32517405
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
- ClinicalTrials.gov ID
- NCT03831581
- Acronym / sponsor ID
- UdeA1003
- Conditions
- Pain, Chronic, Pain, Postoperative
- Keywords
- Erector Spinae Plane, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 6 Feb 2019 (actual)
- 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.
Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block
Detailed description
Interventional study that evaluate dermatomal distribution with pinprick and cold, and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5% at the thoracic level in patients with pain in the thorax and upper abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assignment interventional
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane BlockPatients with chest pain or upper abdomen underwent Erector Spinae Plane Block guided by ultrasound, bupivacaine 0.5% 20 ml was administered in the interfascial plane between the transverse process of T5 and the erector muscles of the spine, 60 minutes after dermatomes distribution was evaluated with pinprick and cold. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years, in the acute / chronic pain service that presents pain in the thoracic region and / or upper hemiabdomen.
Key exclusion criteria (3 listed)
- Women in pregnancy
- Patients with less than 50 Kg of weight
- Dissent of informed consent
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 BlockIn patients with chest pain, ultrasound-guided Erector Spinae Plane Block block was performed at T5 transverse process in the cephalo-caudal direction with Tuohy 18 gauge needle in plane until the needle tip was located in the interfascial plane between the transverse process and the erector spinae muscles, 20 ml of bupivacaine 0.5% was administered and a catheter was inserted if indicated. | Procedure or surgery | Erector Spinae Plane Block |
Primary outcome
Dermatomes with sensitive block
Time frame: 60 minutes
Number (average) of dermatomes with sensitive block with pinprick and cold achieved at 60 minutes after the Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5%. Also, observe the distribution pattern.
7 secondary outcomes
weight
Time frame: 60 minutes
Adverse events
Time frame: 60 minutes and 24 hours
Success rate
Time frame: 60 minutes and 24 hours
Degree of satisfaction
Time frame: 60 minutes and 24 hours
Visual Analogue Scale (VAS)
Time frame: 60 minutes and 24 hours
Height
Time frame: 60 minutes
Age
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 32517405Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.
- Individual participant dataSharing planned: No. Only final results of research
Related trials for Pain, Chronic
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Adriana Cadavid study chair
Universidad de Antioquia
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 in people with Pain, Chronic and Pain, Postoperative, run by Universidad de Antioquia at 1 site in Colombia.
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 1 inclusion and 3 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 24 May 2023. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dermatomes with sensitive block (time frame: 60 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 NCT03831581, which also lists 1 linked publication.
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 24 May 2023.