Heart Valve DiseasesNCT05702151
ESP Block in Robotic Cardiac Surgery
A study testing ESP Block and Morphine injection in people with Heart Valve Diseases and Postoperative Pain, Acute, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Control group will receive standard of care pain management with acetaminophen and morphine in PCA pump, and the intervention group will receive an erector spinae plane block with a continous infusion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases, Postoperative Pain, Acute, Analgesia
- What is being tested?
- ESP Block and Morphine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 22 Dec 2022to Jun 2024
- 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
- Robotic Cardiac Surgery
- Accepts to participate
Who cannot join
- Use of other regional anesthesia technics
- Presence of chronic Pain
- Psychiatric pathology, drug abuse
- Allergy or intolerance to local anesthetics
Trial locations and contacts
1 site in 1 country.
Ricard Navarro, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Jorge Aliaga Medina, MD
Ricard Navarro, PhD
About this study
Official title: Erector Spinae Plane Block in Robotic Cardiac Surgery
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Control group will receive standard of care pain management with acetaminophen and morphine in PCA pump, and the intervention group will receive an erector spinae plane block with a continous infusion of local anesthetic.
At 3 months the patients will be contacted to assess for pain and ask them for they life quality.
Read the detailed description
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Before the surgery and after checking eligibility criteria and exclusion criteria the patients will be asked to enroll to the study. If the agree to participate, they will sign de informed consent and fill the EQL 5D-5L questionnaire.
The day of the surgery, the perioperative process will be performed as usual unless the interventions detailed in this description.
Patients will be transferred to the surgical area, enter to the operating room, monitored and general anesthesia will be performed.
Standard postoperative analgesia group will receive a at the end of the surgery a bolus of IV morphine 0,05mg/kg, followed with infusion of IV morphine 0,25mg/h in Patient Controlled Analgesia protocol (extra bolus on demand of 1mg with lockout interval 20 minutes), and paracetamol 1g every 8 hours.
The experimental group will receive the standard analgesia and an ESP Block. In this group, after the induction of general anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an ipsilateral Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed in this plane.
An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room.
Both groups of patients will emerge from anesthesia in the operative room or at the intensive care unit in the first 6 postoperative hours if possible. After the surgery they will be transfered to the intensive care unit where vital signs will be monitored continuously.
The pain intensity and the total required opioid dose will be registered at 12, 24 and 48 postoperative hours. After acute phase of postoperative pain and typically until chest drainages are retired, the ESP catheter and the IV morphine will be withdrawn. After discharge by usual criteria, 3 months after the surgery patients will be contacted by telephone. Quality of life, pain and if present, its characteristics will be assessed.
- Conditions
- Heart Valve Diseases, Postoperative Pain, Acute, Analgesia
- Being tested
- ESP Block, Morphine injection
- Keywords
- Robotic Cardiac Surgery, ESP Block, Postoperative Pain, Heart Valve disease
- Medical subject headings
- Heart Valve Diseases, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP BlockProcedure or surgery
Also called Erector spinae Plane Block
After induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed. Ropivacaine 0.2% infusion at a 10ml/h rate is started during the surgery.
Morphine injectionDrug
Also called Intravenous opioid infusion analgesia and paracetamol
Intravenous morphine infusion 50mcg/kg/h with Patient Controlled Analgesia extra bolus on demand (1mg bolus with 20 minutes lockout time), and paracetamol 1g every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Morphine infusion | Active comparator | IV morphine 50mcg/kg/h infusion with Patient Controlled Analgesia extra bolus on demand of 1mg (lockout interval 20 minutes), and paracetamol 1g every 8 hours. Receives: Drug: Morphine injection |
| ESP Block analgesia | Experimental | After induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed.
An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. Patient Controlled Analgesia pump will be connected with 1mg IV morphine bolus on demand, and paracetamol 1g every 8 hours, is also delivered. Receives: Procedure: ESP Block; Drug: Morphine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated opioid dose 12h
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Measured: 12 postoperative hours
Accumulated opioid dose 24h
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Measured: 24 ostoperative hours
Accumulated opioid dose 48h
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Measured: 48 postoperative hours
Visual Analogic Scale 12h
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Measured: 12 postoperative hours
Visual Analogic Scale 24h
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Measured: 24 postoperative hours
Visual Analogic Scale 48h
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Measured: 48 postoperative hours
Secondary outcomes (3)
EQ 5-Dimensions 5-Levels
Quality of Life measure with EQ 5D 5L scale, created by the Euro QL group and used to measure life quality, its a scale describing 5 dimensions of life (Mobility, Self care, General activity, pain and discomfort, anxiety and depression) in 5 levels of comfort/discomfort (Score of 1 in each dimensions describes the most comfort). It can be expressed separately or by combining them into an index generated with a standard calculator provided by the EQL group.
Measured: Preoperative and 3 months after surgery
Brief Pain Scale
Pain presence and its characteristics 3 months after surgery described by the brief pain scale. This standard scale describes the pain intensity from 1 to 10 (being 10 the most intense pain) and and DN4 scale will be performed.
Measured: 3 months after surgery
Neuropathic pain assessment
When pain is present, assessment for neuropathic pain characteristics will be assessed using the Douleur neuropathique 4 (DN4) scale, spanish version. This scale assess 10 characteristics of pain, with a maximum score of 10, minimum of 0. Interpreted as positive (neuropathic pain likely) with a score of 7 or more.
Measured: 3 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start22 Dec 2022
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Open Clinical Trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702151
- Sponsor's protocol ID
- ESProbot001
- Status last verified
- Nov 2022
- First submitted
- 19 Dec 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD, unless requested
Publications
Rovira Canudas I. [Postoperatory analgesia for minimally invasive cardiac surgery: which is the ideal technique?]. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):467-9. doi: 10.1016/j.redar.2012.07.010. Epub 2012 Sep 12. No abstract available. Spanish.
PubMed 22980395Freise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4.
PubMed 22058144D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.
PubMed 29169795Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block in Robotic Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05702151
- Acronym / sponsor ID
- ESProbot001
- Conditions
- Heart Valve Diseases, Postoperative Pain, Acute, Analgesia
- Keywords
- Robotic Cardiac Surgery, ESP Block, Postoperative Pain, Heart Valve disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Jan 2023 (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.
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Control group will receive standard of care pain management with acetaminophen and morphine in PCA pump, and the intervention group will receive an erector spinae plane block with a continous infusion of local anesthetic.
At 3 months the patients will be contacted to assess for pain and ask them for they life quality.
Detailed description
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Before the surgery and after checking eligibility criteria and exclusion criteria the patients will be asked to enroll to the study. If the agree to participate, they will sign de informed consent and fill the EQL 5D-5L questionnaire.
The day of the surgery, the perioperative process will be performed as usual unless the interventions detailed in this description.
Patients will be transferred to the surgical area, enter to the operating room, monitored and general anesthesia will be performed.
Standard postoperative analgesia group will receive a at the end of the surgery a bolus of IV morphine 0,05mg/kg, followed with infusion of IV morphine 0,25mg/h in Patient Controlled Analgesia protocol (extra bolus on demand of 1mg with lockout interval 20 minutes), and paracetamol 1g every 8 hours.
The experimental group will receive the standard analgesia and an ESP Block. In this group, after the induction of general anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an ipsilateral Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed in this plane.
An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room.
Both groups of patients will emerge from anesthesia in the operative room or at the intensive care unit in the first 6 postoperative hours if possible. After the surgery they will be transfered to the intensive care unit where vital signs will be monitored continuously.
The pain intensity and the total required opioid dose will be registered at 12, 24 and 48 postoperative hours. After acute phase of postoperative pain and typically until chest drainages are retired, the ESP catheter and the IV morphine will be withdrawn. After discharge by usual criteria, 3 months after the surgery patients will be contacted by telephone. Quality of life, pain and if present, its characteristics will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Open Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Morphine infusion | Active comparator | Drug: Morphine injectionIV morphine 50mcg/kg/h infusion with Patient Controlled Analgesia extra bolus on demand of 1mg (lockout interval 20 minutes), and paracetamol 1g every 8 hours. |
| ESP Block analgesia | Experimental | Procedure: ESP Block, Drug: Morphine injectionAfter induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed. An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. Patient Controlled Analgesia pump will be connected with 1mg IV morphine bolus on demand, and paracetamol 1g every 8 hours, is also delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Robotic Cardiac Surgery
- Accepts to participate
Key exclusion criteria (4 listed)
- Use of other regional anesthesia technics
- Presence of chronic Pain
- Psychiatric pathology, drug abuse
- Allergy or intolerance to local anesthetics
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 |
|---|---|---|
| ESP BlockAlso: Erector spinae Plane BlockAfter induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed. Ropivacaine 0.2% infusion at a 10ml/h rate is started during the surgery. | Procedure or surgery | ESP Block analgesia |
| Morphine injectionAlso: Intravenous opioid infusion analgesia and paracetamolIntravenous morphine infusion 50mcg/kg/h with Patient Controlled Analgesia extra bolus on demand (1mg bolus with 20 minutes lockout time), and paracetamol 1g every 8 hours. | Drug | ESP Block analgesia, Morphine infusion |
Primary outcome
Accumulated opioid dose 12h
Time frame: 12 postoperative hours
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Accumulated opioid dose 24h
Time frame: 24 ostoperative hours
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Accumulated opioid dose 48h
Time frame: 48 postoperative hours
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Visual Analogic Scale 12h
Time frame: 12 postoperative hours
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Visual Analogic Scale 24h
Time frame: 24 postoperative hours
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Visual Analogic Scale 48h
Time frame: 48 postoperative hours
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
3 secondary outcomes
EQ 5-Dimensions 5-Levels
Time frame: Preoperative and 3 months after surgery
Brief Pain Scale
Time frame: 3 months after surgery
Neuropathic pain assessment
Time frame: 3 postoperative months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 22980395Rovira Canudas I. [Postoperatory analgesia for minimally invasive cardiac surgery: which is the ideal technique?]. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):467-9. doi: 10.1016/j.redar.2012.07.010. Epub 2012 Sep 12. No abstract available. Spanish.
- Background: PubMed 22058144Freise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4.
- Background: PubMed 29169795D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Individual participant dataSharing planned: No. There is no plan to share the IPD, unless requested
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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.
Ricard Navarro, PhD 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 ESP Block and Morphine injection in people with Heart Valve Diseases and Postoperative Pain, Acute, 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 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 27 Jan 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 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 Jorge Aliaga, MD (932275400 ext. 5558, aliaga@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulated opioid dose 12h (time frame: 12 postoperative hours). The study lists 6 primary outcomes in all. 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 NCT05702151, which also lists 5 linked publications.
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 27 Jan 2023; AzTrials last refreshed its copy on 3 Nov 2026.