Pain, PostoperativeESPNCT04011501
Erector Spinae Plane Block for Minimal Invasive Cardiac Surgery (Heart-Port).
A study testing Continuous Erector spinae block in people with Pain, Postoperative and Heart Valve Diseases, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Minimally invasive cardiac surgery is performed through a right thoracotomy, the pain management of this surgery is of great importance. Regional techniques such as thoracic epidural anesthesia or paravertebral block are excellent techniques for the management of postoperative pain in thoracic surgery but they have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Heart Valve Diseases
- What is being tested?
- Continuous Erector spinae block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 7 May 2019to 1 Oct 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing minimally invasive cardiac surgery
- Acceptance to participate in the study
- ASA physical status II-IV
- Age > 18 years
Who cannot join
- Refusal to participate in the study
- Allergy to local anesthetics
- History of substance abuse
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, 0836
Xavier Sala-Blanch, MD, 34626353609, xavi.sala.blanch@gmail.com
About this study
Minimally invasive cardiac surgery is performed through a right thoracotomy, the pain management of this surgery is of great importance. Regional techniques such as thoracic epidural anesthesia or paravertebral block are excellent techniques for the management of postoperative pain in thoracic surgery but they have disadvantages that make it difficult to use in this surgery. On the one hand, anticoagulation in these patients increases the risk of complications related to the use of neuraxial techniques and, on the other hand, the technical difficulty of paravertebral block.
The erector of the spine block is a technically simple block and with a low risk of associated complications.
The aim of the study is to evaluate the feasibility and benefits in the relationship of postoperative pain management in patients undergoing minimally invasive cardiac surgery when using continuous unilateral blockade of the erector in a small cohort of patients.
Read the detailed description
An observational study of a series of 20 cases will be carried out based on the casuistry of minimally invasive cardiac surgery of the investigator's center. The performance of analgesic blockade called ESP with catheter placement for continuous analgesia, at the level of the 6th thoracic vertebra in adult patients, ASA physical status I-III, which will undergo minimally invasive cardiac surgery, will be part of the multimodal analgesia strategy.
After compliance with the inclusion criteria, with the acceptance and signature of the informed consent by the participating patients, the following procedure will be followed:
- Patients will be routinely assessed by an anesthesiologist of the service, later they will enter the operating room, where the vital signs will be monitored and the usual anesthetic technique will be used for minimally invasive cardiac surgery, that is, general anesthesia.
- The erector block of the spine and the catheter installation for continuous analgesia will be performed in the operating room, after induction of general anesthesia. Patients will be placed in the left lateral decubitus position, and under sterile technique with asepsis of the thoracolumbar area, erector spine block and catheter placement will be performed for continuous analgesia prior to the surgical procedure. The spinal erector musculature will be located at the level of the transverse process of the 6th left thoracic vertebra.Initially a volume of 20 ml of Levobupivacaine 0.25% will be administered. Subsequently a 22G (Gauge) catheter will be introduced and fixed 10-12 cm from the skin. The surgery will begin according to the usual practice. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution.
- During and after the surgery, the intravenous analgesic protocols already established by the anesthesiology service will be used, so that the realization of the blocking in the plane of the erector musculature will not modify the prescribed analgesic or rescue regimens employees for minimally invasive cardiac surgery, these include the use of an opioid pump on demand by the patient. After the surgery, the intensity of postoperative pain during the first 48 hours will be observed and recorded by the Acute Pain Unit of the Anaesthesiology Service, blind to the study objectives, following its usual practice and assessment.
- Researchers will record those variables aimed at evaluating the intensity of acute postoperative pain after minimally invasive cardiac surgery after performing spinal erector block and catheter placement for continuous analgesia in the study period, such as NRS (Numeric rating scale), Paired intravenous analgesia and opioid use.
These results will be included, anonymously, in an Excel database made for this purpose for further analysis. The variables will be recorded in a single intervention
- Conditions
- Pain, Postoperative, Heart Valve Diseases
- Being tested
- Continuous Erector spinae block
- Keywords
- erector spinae plane block, thoracic surgery, cardiac surgical procedures, pain, postoperative
- Medical subject headings
- Pain, Postoperative, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Erector spinae blockProcedure or surgery
Erector spine block and catheter placement will be performed for continuous analgesia prior to the surgical procedure.A initial bolus of 20 ml of Levobupivacaine 0.25% will be administered. Subsequently a 22G catheter will be introduced. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution.
| Study group | Role | What they receive |
|---|---|---|
| Continuous unilateral ESP block | Experimental | Erector spine block and catheter placement will be performed for continuous analgesia on this group of patients undergoing minimally invasive cardiac surgery. Initially a volume of 20 ml of Levobupivacaine 0.25% will be administered and subsequently a 22G catheter will be introduced and fixed 10-12 cm from the skin. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution. Receives: Procedure: Continuous Erector spinae block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of postoperative analgesia
Post operative pain scores will be recorded with a NRS(numerical rating scala) from 0 to 10 ( 0=no pain, 10= pain as bad as can be) worst score at 12 hrs, 24 hrs and 48 hrs period will be scored.
Measured: up to 48 hours
Morphine consumption
total morphine consumption in milligrams at 12 hrs, 24 hrs and 48 hrs will be scored.
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start7 May 2019
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Sala-Blanch, Hospital Clinic of Barcelona
- Investigators
- Xavier Sala-Blanch, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011501
- Sponsor's protocol ID
- HCB/2019/0377
- Acronym
- ESP
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Minimal Invasive Cardiac Surgery (Heart-Port).
- ClinicalTrials.gov ID
- NCT04011501
- Acronym / sponsor ID
- ESP / HCB/2019/0377
- Conditions
- Pain, Postoperative, Heart Valve Diseases
- Keywords
- erector spinae plane block, thoracic surgery, cardiac surgical procedures, pain, postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 8 Jul 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.
Minimally invasive cardiac surgery is performed through a right thoracotomy, the pain management of this surgery is of great importance. Regional techniques such as thoracic epidural anesthesia or paravertebral block are excellent techniques for the management of postoperative pain in thoracic surgery but they have disadvantages that make it difficult to use in this surgery. On the one hand, anticoagulation in these patients increases the risk of complications related to the use of neuraxial techniques and, on the other hand, the technical difficulty of paravertebral block.
The erector of the spine block is a technically simple block and with a low risk of associated complications.
The aim of the study is to evaluate the feasibility and benefits in the relationship of postoperative pain management in patients undergoing minimally invasive cardiac surgery when using continuous unilateral blockade of the erector in a small cohort of patients.
Detailed description
An observational study of a series of 20 cases will be carried out based on the casuistry of minimally invasive cardiac surgery of the investigator's center. The performance of analgesic blockade called ESP with catheter placement for continuous analgesia, at the level of the 6th thoracic vertebra in adult patients, ASA physical status I-III, which will undergo minimally invasive cardiac surgery, will be part of the multimodal analgesia strategy.
After compliance with the inclusion criteria, with the acceptance and signature of the informed consent by the participating patients, the following procedure will be followed:
- Patients will be routinely assessed by an anesthesiologist of the service, later they will enter the operating room, where the vital signs will be monitored and the usual anesthetic technique will be used for minimally invasive cardiac surgery, that is, general anesthesia.
- The erector block of the spine and the catheter installation for continuous analgesia will be performed in the operating room, after induction of general anesthesia. Patients will be placed in the left lateral decubitus position, and under sterile technique with asepsis of the thoracolumbar area, erector spine block and catheter placement will be performed for continuous analgesia prior to the surgical procedure. The spinal erector musculature will be located at the level of the transverse process of the 6th left thoracic vertebra.Initially a volume of 20 ml of Levobupivacaine 0.25% will be administered. Subsequently a 22G (Gauge) catheter will be introduced and fixed 10-12 cm from the skin. The surgery will begin according to the usual practice. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution.
- During and after the surgery, the intravenous analgesic protocols already established by the anesthesiology service will be used, so that the realization of the blocking in the plane of the erector musculature will not modify the prescribed analgesic or rescue regimens employees for minimally invasive cardiac surgery, these include the use of an opioid pump on demand by the patient. After the surgery, the intensity of postoperative pain during the first 48 hours will be observed and recorded by the Acute Pain Unit of the Anaesthesiology Service, blind to the study objectives, following its usual practice and assessment.
- Researchers will record those variables aimed at evaluating the intensity of acute postoperative pain after minimally invasive cardiac surgery after performing spinal erector block and catheter placement for continuous analgesia in the study period, such as NRS (Numeric rating scale), Paired intravenous analgesia and opioid use.
These results will be included, anonymously, in an Excel database made for this purpose for further analysis. The variables will be recorded in a single intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous unilateral ESP block | Experimental | Procedure: Continuous Erector spinae blockErector spine block and catheter placement will be performed for continuous analgesia on this group of patients undergoing minimally invasive cardiac surgery. Initially a volume of 20 ml of Levobupivacaine 0.25% will be administered and subsequently a 22G catheter will be introduced and fixed 10-12 cm from the skin. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects undergoing minimally invasive cardiac surgery
- Acceptance to participate in the study
- ASA physical status II-IV
- Age > 18 years
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Allergy to local anesthetics
- History of substance abuse
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 |
|---|---|---|
| Continuous Erector spinae blockErector spine block and catheter placement will be performed for continuous analgesia prior to the surgical procedure.A initial bolus of 20 ml of Levobupivacaine 0.25% will be administered. Subsequently a 22G catheter will be introduced. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution. | Procedure or surgery | Continuous unilateral ESP block |
Primary outcome
Assesment of postoperative analgesia
Time frame: up to 48 hours
Post operative pain scores will be recorded with a NRS(numerical rating scala) from 0 to 10 ( 0=no pain, 10= pain as bad as can be) worst score at 12 hrs, 24 hrs and 48 hrs period will be scored.
Morphine consumption
Time frame: up to 48 hours
total morphine consumption in milligrams at 12 hrs, 24 hrs and 48 hrs will be scored.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Xavier Sala-Blanch, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Erector spinae block in people with Pain, Postoperative and Heart Valve Diseases, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Jul 2019. 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 Spain. 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 Xavier Sala-Blanch, MD (346263536009, xavi.sala.blanch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of postoperative analgesia (time frame: up to 48 hours). The study lists 2 primary outcomes in all. 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 12 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.