Surgery StressNCT04924335
The Effects of Erector Spinae Plane (ESP) Block on Surgery-related Stress Response in Cardiac Surgery With ERAS
A study testing Erector spinae plane block in people with Surgery Stress, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Surgery-induced pain reveals its own metabolic and inflammatory responses, resulting in a further increase in noxious pathways that are already occurring. Even though it is difficult to distinguish whether the metabolic and inflammatory responses are pain-induced or surgical-induced, it is clear that pain can cause a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery Stress
- 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
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Aug 2021
- 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
- Adult patients who will undergo open-heart surgery with ERAS protocol
Who cannot join
- Emergency surgeries
- Patients with allergic reactions to anesthesia and analgesia drugs to be used
- Patients who do not want to participate in the study voluntarily
- Severe systemic disease (kidney, liver, pulmonary, endocrine)
- Substance abuse history
- History of chronic pain
Show all 9Show fewer
- Psychiatric problems and communication difficulties
- Patients who need revision due to hemostasis in the postoperative period
- Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital
Ankara, Select State/Province, 06800
About this study
Official title: Ultrasound-guided Erector Spinae Plane (ESP) Block Attenuates Surgery-related Stress Response in Cardiac Surgery Patients Undergoing Enhanced Recovery After Surgery (ERAS) Program
Surgery-induced pain reveals its own metabolic and inflammatory responses, resulting in a further increase in noxious pathways that are already occurring. Even though it is difficult to distinguish whether the metabolic and inflammatory responses are pain-induced or surgical-induced, it is clear that pain can cause a response. This study aims to investigate the effects of erector spinae plane block on surgery-related stress response with enhanced recovery after cardiac surgery protocol.
Read the detailed description
The Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) program includes a perioperative multimodal, opioid-sparing pain management plan as an essential component of any comprehensive program. A multimodal pain management plan is nonopioid systemic analgesic agents, regional and local anesthetic techniques, and judicious use of opioids. This study aims to examine inflammatory and hematological parameters in patients who underwent cardiac surgery with ERAS, with and without preoperative bilateral erector spinae plane block (ESP). For this purpose, the presence of an obstacle ESP block application in the preoperative period will be investigated in patients who are prepared for cardiac surgery according to ERAS principles, and the patient's group will be determined accordingly. An analgesia protocol that does not include a regional technique will be applied to the patient in cases such as the patient's refusal to allow preoperative block and the presence of a situation that does not allow blockage in the block area. The perioperative characteristics of ERAS patients with and without ESP block will be examined, intraoperative lactate, and preop-postoperative hemogram-albumin-C reactive protein parameters will be recorded.
ERAS patients with ESP block: After preparation in accordance with the ERAS protocol, ultrasound-guided bilateral ESP block will be performed with 20 ml of 0.025% bupivacaine at T5-7 levels in patients taken to the operating room in the preoperative period, and will be administered intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.
ERAS patients without ESP block: After preparation according to the ERAS protocol, patients will be administered lidocaine, ketamine, paracetamol, and intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.
- Conditions
- Surgery Stress
- Being tested
- Erector spinae plane block
- Keywords
- erector spinae plane block, cardiac surgery, enhanced recovery after surgery program, lactate, stress response, c reactive protein
- Medical subject headings
- Fractures, Stress
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
Preoperative ultrasound-guided bilateral erector spinae plane block with 20 ml 0.025% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| ESP group | Active comparator | ESP group patients will be performed ultrasound-guided erector spinae plane block with 20 ml 0.025% Bupivacaine, preoperatively and will receive ERAS cardiac anesthesia protocol Receives: Procedure: Erector spinae plane block |
| Conventional group | No intervention | The conventional group will receive ERAS cardiac anesthesia protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal measurements- after anesthesia induction
After induction of anesthesia, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Measured: After anesthesia induction, an average of 5 minutes
Basal measurements- after anesthesia induction
After induction of anesthesia, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.
Measured: After anesthesia induction, an average of 5 minutes
Second measurements- after cardiopulmonary bypass initiation
After cardiopulmonary bypass initiation, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Measured: After cardiopulmonary bypass inititation, an average of 5 minutes
Second measurements- after cardiopulmonary bypass initiation
After cardiopulmonary bypass initiation, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.
Measured: After cardiopulmonary bypass inititation, an average of 5 minutes
Third measurements- during cardiopulmonary bypass, at lowest temperature
During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Measured: During cardiopulmonary bypass, an average of 10 minutes
Third measurements- during cardiopulmonary bypass, at lowest temperature
During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.
Measured: During cardiopulmonary bypass, an average of 10 minutes
Fourth measurements- end of cardiopulmonary bypass
At the end of cardiopulmonary bypass, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Measured: At the end of cardiopulmonary bypass, an average of 10 minutes
Fourth measurements- end of cardiopulmonary bypass
At the end of cardiopulmonary bypass, blood gas analysis will be performed and hemoglobin level (g(dL) will be recorded.
Measured: At the end of cardiopulmonary bypass, an average of 10 minutes
Fifth measurements- end of surgery
At the end of surgery, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Measured: At the end of surgery, an average of 20 minutes
Fifth measurements- end of surgery
At the end of surgery, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.
Measured: At the end of surgery, an average of 20 minutes
Secondary outcomes (5)
Preoperative complete blood count
Preoperative complete blood count will be evaluated and recorded.
Measured: The day before surgery, 24 hours
Preoperative albumin
Preoperative albumin levels will be evaluated and recorded.
Measured: The day before surgery, 24 hours
Postoperative C reactive protein
Postoperative C reactive protein levels will be evaluated and recorded.
Measured: 6 hours after surgery
Postoperative complete blood count
Postoperative complete blood count will be evaluated and recorded.
Measured: 6 hours after surgery
Postoperative albumin
Postoperative albumin levels will be evaluated and recorded.
Measured: 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery StressStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Balci, Ankara City Hospital Bilkent
- Investigators
- Serdar Günaydın, Professor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924335
- Sponsor's protocol ID
- MH2.2
- Status last verified
- Aug 2021
- First submitted
- 22 May 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Erector Spinae Plane (ESP) Block Attenuates Surgery-related Stress Response in Cardiac Surgery Patients Undergoing Enhanced Recovery After Surgery (ERAS) Program
- ClinicalTrials.gov ID
- NCT04924335
- Acronym / sponsor ID
- MH2.2
- Conditions
- Surgery Stress
- Keywords
- erector spinae plane block, cardiac surgery, enhanced recovery after surgery program, lactate, stress response, c reactive protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 14 Jun 2021 (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.
Surgery-induced pain reveals its own metabolic and inflammatory responses, resulting in a further increase in noxious pathways that are already occurring. Even though it is difficult to distinguish whether the metabolic and inflammatory responses are pain-induced or surgical-induced, it is clear that pain can cause a response. This study aims to investigate the effects of erector spinae plane block on surgery-related stress response with enhanced recovery after cardiac surgery protocol.
Detailed description
The Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) program includes a perioperative multimodal, opioid-sparing pain management plan as an essential component of any comprehensive program. A multimodal pain management plan is nonopioid systemic analgesic agents, regional and local anesthetic techniques, and judicious use of opioids. This study aims to examine inflammatory and hematological parameters in patients who underwent cardiac surgery with ERAS, with and without preoperative bilateral erector spinae plane block (ESP). For this purpose, the presence of an obstacle ESP block application in the preoperative period will be investigated in patients who are prepared for cardiac surgery according to ERAS principles, and the patient's group will be determined accordingly. An analgesia protocol that does not include a regional technique will be applied to the patient in cases such as the patient's refusal to allow preoperative block and the presence of a situation that does not allow blockage in the block area. The perioperative characteristics of ERAS patients with and without ESP block will be examined, intraoperative lactate, and preop-postoperative hemogram-albumin-C reactive protein parameters will be recorded.
ERAS patients with ESP block: After preparation in accordance with the ERAS protocol, ultrasound-guided bilateral ESP block will be performed with 20 ml of 0.025% bupivacaine at T5-7 levels in patients taken to the operating room in the preoperative period, and will be administered intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.
ERAS patients without ESP block: After preparation according to the ERAS protocol, patients will be administered lidocaine, ketamine, paracetamol, and intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP group | Active comparator | Procedure: Erector spinae plane blockESP group patients will be performed ultrasound-guided erector spinae plane block with 20 ml 0.025% Bupivacaine, preoperatively and will receive ERAS cardiac anesthesia protocol |
| Conventional group | No intervention | –The conventional group will receive ERAS cardiac anesthesia protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who will undergo open-heart surgery with ERAS protocol
Key exclusion criteria (9 listed)
- Emergency surgeries
- Patients with allergic reactions to anesthesia and analgesia drugs to be used
- Patients who do not want to participate in the study voluntarily
- Severe systemic disease (kidney, liver, pulmonary, endocrine)
- Substance abuse history
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 blockPreoperative ultrasound-guided bilateral erector spinae plane block with 20 ml 0.025% bupivacaine. | Procedure or surgery | ESP group |
Primary outcome
Basal measurements- after anesthesia induction
Time frame: After anesthesia induction, an average of 5 minutes
After induction of anesthesia, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Basal measurements- after anesthesia induction
Time frame: After anesthesia induction, an average of 5 minutes
After induction of anesthesia, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.
Second measurements- after cardiopulmonary bypass initiation
Time frame: After cardiopulmonary bypass inititation, an average of 5 minutes
After cardiopulmonary bypass initiation, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Second measurements- after cardiopulmonary bypass initiation
Time frame: After cardiopulmonary bypass inititation, an average of 5 minutes
After cardiopulmonary bypass initiation, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.
Third measurements- during cardiopulmonary bypass, at lowest temperature
Time frame: During cardiopulmonary bypass, an average of 10 minutes
During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Third measurements- during cardiopulmonary bypass, at lowest temperature
Time frame: During cardiopulmonary bypass, an average of 10 minutes
During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.
Fourth measurements- end of cardiopulmonary bypass
Time frame: At the end of cardiopulmonary bypass, an average of 10 minutes
At the end of cardiopulmonary bypass, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Fourth measurements- end of cardiopulmonary bypass
Time frame: At the end of cardiopulmonary bypass, an average of 10 minutes
At the end of cardiopulmonary bypass, blood gas analysis will be performed and hemoglobin level (g(dL) will be recorded.
Fifth measurements- end of surgery
Time frame: At the end of surgery, an average of 20 minutes
At the end of surgery, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Fifth measurements- end of surgery
Time frame: At the end of surgery, an average of 20 minutes
At the end of surgery, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.
5 secondary outcomes
Preoperative complete blood count
Time frame: The day before surgery, 24 hours
Preoperative albumin
Time frame: The day before surgery, 24 hours
Postoperative C reactive protein
Time frame: 6 hours after surgery
Postoperative complete blood count
Time frame: 6 hours after surgery
Postoperative albumin
Time frame: 6 hours after surgery
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 20 Aug 2021.
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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.
Serdar Günaydın, Professor principal investigator
Ankara City Hospital Bilkent
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 Surgery Stress, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 9 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 20 Aug 2021. 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 Turkey (Türkiye). 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?
Basal measurements- after anesthesia induction (time frame: After anesthesia induction, an average of 5 minutes). The study lists 10 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 20 Aug 2021.