Cardiac SurgeryESPCATHEARTNCT03541837
Erector Spinae Plane Block and Pain Management in Cardiac Surgery
A study testing Ropivacaine in people with Cardiac Surgery and Adult, run by Vinmec Healthcare System at 1 site in Vietnam.
Trial summary
Evaluation of the benefit effects of Peri-Operative analgesia by Continuous Bilateral Erector Spinae Plane block(ESP) for Open Cardiac Surgery: A case series prospective study with a comparison a retrospective case series (Before and after) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Surgery, Adult
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Oct 2017to 1 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent signed
- Open heart surgery
- Hemodynamic stable after anesthesia induction No variation more than 20% of blood pressure
Who cannot join
- refusal by patient
- Unstable hemodynamic after induction
- Failure of ESP catheter insertion Must have 2 ESP catheter well inserted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Thoracic Erector Spinae Plane Blocks Within an Enhanced Recovery Program Decreases Opioids Consumption and Improves Patient Postoperative Rehabilitation After Open Cardiac Surgery: A Controlled Before-After Study
Evaluation of the benefit effects of Peri-Operative analgesia by Continuous Bilateral Erector Spinae Plane block(ESP) for Open Cardiac Surgery: A case series prospective study with a comparison a retrospective case series (Before and after)
Read the detailed description
After Patient's information and consent from the Ethical committee of VinMec Healthcare (#06/2017/HDD-VMEC) the anesthesia team will perform to all adult patients for open heart surgery after the anesthesia induction a bilateral insertion of an Erector Spinae Plane Block catheter under ultrasound guidance The Block performance :
Patient in right lateral decubitus. The anesthesiologist will use an high-frequency linear ultrasound transducer sagitally at T4 level to identify the lateral extremity of the T4 transverse process (Logic E GE USE). After inserting in plane a Tuohy needle 80 mm 18G the anesthesiologist will locate the tip of the needle and confirm by hydrodissection the inter-fascial space between the inter-transverse ligament anteriorly and the fascia of the Erector Spinae Muscle posteriorly . He will insert under ultrasound vision a catheter (Perifix B.Braun Germany) . The anesthesiologist check the right position of the catheter with a dextrose 5% injection = 2mL under ultrasound vision and see the spread of the Dextrose between in the inter-fascial space. This procedure will be bilateral. The catheter will have a yellow label on the Huer®-Lock connector to identify clearly that it is regional analgesia catheter to prevent any errors in these patients will a lot of catheters.
After this control an induction dose of Ropivacaine (0.5%) 0.25mL/Kg is injected in each catheter ( Loading dose).
8 h after a automatic infusion of Ropivacaine (0.2%) will be infused throw the 2 ESP catheters the infusion regimen will be Intermittent automatic bolus every 6h. on each catheter. The bolus on the second catheter will be delayed by 1 hour to minor the maximal plasmatic concentration.
Volume of the bolus:
For 40 to 50 kg patient the volume of intermittent automatic bolus will be 6 mL/ 6H/ Side For 50 to 60 kg patient the volume of intermittent automatic bolus will be 8 mL / 6H/ Side For 60 to 70 kg patient the volume of intermittent automatic bolus will be 10 mL / 6H/ Side For a 70 kg and > 1.70 m Patient the volume of intermittent automatic bolus will be 12 mL / 6H/ Side
If the block extension is not enough additional bolus by clinician only of 8 mL maximum 3 per day and 1 hour after the last automatic bolus delivered
If the analgesia is not efficient after 1 additional bolus the catheters will be removed and we will prescribe the classical IV analgesia as before.
The regional analgesia will be up to 4 hours after mediastinal drain removal and a maximum of 76h. after catheter incision
A Bi Daily inspection of the catheters insertion points will be done. If redness around puncture point the catheters will be removed and shift to classical IV analgesia to prevent any infection.
The criteria studied will be:
Consumption of opioids at 48h Variation of Blood pressure during sternotomy Level of pain at rest and mob after the surgery Time to extubate the patient Early mobilisation after surgery the quality of thorax expansion Level of pain 1 month after the surgery and limited activity at one month
The control group was an historical group of twenty consecutive patients, operated by the same surgeons from June 8th 2017 and August 1th 2017 and matched with the studied group, in which data were noted just before the introduction of ESB in the ERAS program. All data from the control group come from the centralized computer network of patient records at Vinmec University Hospital.
- Conditions
- Cardiac Surgery, Adult
- Being tested
- Ropivacaine
- Keywords
- Bilateral ESP Catheter, Open heart surgery, opioid free post op analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called ESP catheter
ESP catheter
| Study group | Role | What they receive |
|---|---|---|
| peri operative analgesia | Other | Post operative regional analgesia by Erector Spinae bilateral catheters with infusion of ropivacaine Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Opioids consumption
Total dose of morphine used in post operative in mg of Morphine
Measured: 48h.
Secondary outcomes (3)
Acute post op pain
VAS Visual analogically scale from 0 to 10 at rest and Thorax mobilisation
Measured: 1 hour after extubation
Pain at one month after surgery
VAS Visual analogically scale from 0 to 10 at rest and mobilisation
Measured: One month exactly = 30 days after date of surgery
Peri operative sufentanil consumption
Total dose of sufentanil in msg/kg
Measured: from induction anesthesia to last point of the skin (end of surgery) Time unit Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start20 Oct 2017
- Primary completion25 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective series case compared to a before group of consecutive patients
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vinmec Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huyen vu, Study chair, VINMEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541837
- Sponsor's protocol ID
- VINMEC HS
- Acronym
- ESPCATHEART
- Status last verified
- May 2018
- First submitted
- 12 Mar 2018
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: excel sheet
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Thoracic Erector Spinae Plane Blocks Within an Enhanced Recovery Program Decreases Opioids Consumption and Improves Patient Postoperative Rehabilitation After Open Cardiac Surgery: A Controlled Before-After Study
- ClinicalTrials.gov ID
- NCT03541837
- Acronym / sponsor ID
- ESPCATHEART / VINMEC HS
- Conditions
- Cardiac Surgery, Adult
- Keywords
- Bilateral ESP Catheter, Open heart surgery, opioid free post op analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vinmec Healthcare SystemUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 25 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 31 May 2018 (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.
Evaluation of the benefit effects of Peri-Operative analgesia by Continuous Bilateral Erector Spinae Plane block(ESP) for Open Cardiac Surgery: A case series prospective study with a comparison a retrospective case series (Before and after)
Detailed description
After Patient's information and consent from the Ethical committee of VinMec Healthcare (#06/2017/HDD-VMEC) the anesthesia team will perform to all adult patients for open heart surgery after the anesthesia induction a bilateral insertion of an Erector Spinae Plane Block catheter under ultrasound guidance The Block performance :
Patient in right lateral decubitus. The anesthesiologist will use an high-frequency linear ultrasound transducer sagitally at T4 level to identify the lateral extremity of the T4 transverse process (Logic E GE USE). After inserting in plane a Tuohy needle 80 mm 18G the anesthesiologist will locate the tip of the needle and confirm by hydrodissection the inter-fascial space between the inter-transverse ligament anteriorly and the fascia of the Erector Spinae Muscle posteriorly . He will insert under ultrasound vision a catheter (Perifix B.Braun Germany) . The anesthesiologist check the right position of the catheter with a dextrose 5% injection = 2mL under ultrasound vision and see the spread of the Dextrose between in the inter-fascial space. This procedure will be bilateral. The catheter will have a yellow label on the Huer®-Lock connector to identify clearly that it is regional analgesia catheter to prevent any errors in these patients will a lot of catheters.
After this control an induction dose of Ropivacaine (0.5%) 0.25mL/Kg is injected in each catheter ( Loading dose).
8 h after a automatic infusion of Ropivacaine (0.2%) will be infused throw the 2 ESP catheters the infusion regimen will be Intermittent automatic bolus every 6h. on each catheter. The bolus on the second catheter will be delayed by 1 hour to minor the maximal plasmatic concentration.
Volume of the bolus:
For 40 to 50 kg patient the volume of intermittent automatic bolus will be 6 mL/ 6H/ Side For 50 to 60 kg patient the volume of intermittent automatic bolus will be 8 mL / 6H/ Side For 60 to 70 kg patient the volume of intermittent automatic bolus will be 10 mL / 6H/ Side For a 70 kg and > 1.70 m Patient the volume of intermittent automatic bolus will be 12 mL / 6H/ Side
If the block extension is not enough additional bolus by clinician only of 8 mL maximum 3 per day and 1 hour after the last automatic bolus delivered
If the analgesia is not efficient after 1 additional bolus the catheters will be removed and we will prescribe the classical IV analgesia as before.
The regional analgesia will be up to 4 hours after mediastinal drain removal and a maximum of 76h. after catheter incision
A Bi Daily inspection of the catheters insertion points will be done. If redness around puncture point the catheters will be removed and shift to classical IV analgesia to prevent any infection.
The criteria studied will be:
Consumption of opioids at 48h Variation of Blood pressure during sternotomy Level of pain at rest and mob after the surgery Time to extubate the patient Early mobilisation after surgery the quality of thorax expansion Level of pain 1 month after the surgery and limited activity at one month
The control group was an historical group of twenty consecutive patients, operated by the same surgeons from June 8th 2017 and August 1th 2017 and matched with the studied group, in which data were noted just before the introduction of ESB in the ERAS program. All data from the control group come from the centralized computer network of patient records at Vinmec University Hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective series case compared to a before group of consecutive patients
| Arm | Type | Receives |
|---|---|---|
| peri operative analgesia | Other | Drug: RopivacainePost operative regional analgesia by Erector Spinae bilateral catheters with infusion of ropivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consent signed
- Open heart surgery
- Hemodynamic stable after anesthesia induction No variation more than 20% of blood pressure
Key exclusion criteria (3 listed)
- refusal by patient
- Unstable hemodynamic after induction
- Failure of ESP catheter insertion Must have 2 ESP catheter well inserted
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 |
|---|---|---|
| RopivacaineAlso: ESP catheterESP catheter | Drug | peri operative analgesia |
Primary outcome
Post operative Opioids consumption
Time frame: 48h.
Total dose of morphine used in post operative in mg of Morphine
3 secondary outcomes
Acute post op pain
Time frame: 1 hour after extubation
Pain at one month after surgery
Time frame: One month exactly = 30 days after date of surgery
Peri operative sufentanil consumption
Time frame: from induction anesthesia to last point of the skin (end of surgery) Time unit Hour
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 31 May 2018.
- Individual participant dataSharing planned: Yes. excel sheet
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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.
huyen vu study chair
VINMEC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Cardiac Surgery and Adult, run by Vinmec Healthcare System at 1 site in Vietnam.
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 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 31 May 2018. 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 Vietnam. 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?
Post operative Opioids consumption (time frame: 48h.). 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 31 May 2018.