Morphine ConsumptionNCT04090099
Bilateral Erector Spina Block Versus Parasternal Block in Adult Heart Surgery
A study testing Erector spina plane block in people with Morphine Consumption and Pain, Postoperative, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial summary
Inadequate pain relief after cardiac surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. The use of special opioid-based analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention, respiratory depression and delayed tracheal extubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morphine Consumption, Pain, Postoperative
- What is being tested?
- Erector spina plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 17 Sep 2019to 15 May 2022
- 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
- Male and / or female patients
- Aged 18-65 years
- Patients who will have coronary artery surgery under cardiopulmonary baypass (changing one, two and three vessels) with normal left ventricular function,
- Valve diseases with normal left ventricular function,
- ASD (Atrial Septal Defect) cases for atrial septal defect closure
- Patients with valve + CABG without left ventricular dysfunction will be included in the study.
- Ejection- Fraction> 50-55
Who cannot join
- Emergency and repeat heart surgery cases
- Advanced left coronary artery disease and left ventricular dysfunction
- Receiving preoperative inotropic support therapy,
- With mitral stenosis with atrial tombus,
- With low cardiac out put syndrome,
- Need intra-aortic balloon pump during surgery,
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- Bleeding and coagulation disorder,
- Liver and kidney dysfunction,
- Patients with uncontrolled diabetes mellitus and coronary artery pulmonary disease,
- Opioid, analgesic and bupivacaine allergy,
- Patients with atrial fbrilation using anticoagulants
- Patients with cognitive dysfunction
- Patients who do not want to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kahramanmaras Sutcu Imam Univercity Faculty of edicine
Kahramanmaraş, Onikişubat, 251/A 46040
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, Onikişubat, 251/A 46040
About this study
Official title: Ultrasound-GTrialuided Bilateral Erector Spina Block Versus Parasternal Block in Adult Cardiac Surgery: A Prospective, Randomized, Controlled Study.
Inadequate pain relief after cardiac surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. The use of special opioid-based analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention, respiratory depression and delayed tracheal extubation. Regional anesthesia techniques such as pectoralis nerve block and serratus anterior block provide analgesia in the sternum and pain relief in the lateral / posterior chest Wall. Erector spinae (ESP) block, a new and simple myofascial block, provides wide multi-dermatomal sensory block. In the T5 spinous process, bilateral ESP block provides analgesia from T2 to T9 sensory level, resulting in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block may provide adequate analgesia for median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Median sternotomy incision and mediastinal tube regions are the major source of pain in patients undergoing cardiac surgery. The anterior and posterior branches of the intercostal nerves give nerves to the sternum. Parasternal local anesthetic infiltration around the sternum is effective in providing early postoperative analgesia and reducing opioid requirements and therefore has positive effects on healing. This simple and fast technique can be used even for anticoagulated patients.
Read the detailed description
99 patients will be included in the study. Group C (Control, n = 31), Group ES (Erector Spina, n = 31), Group PS (Parasternal Intercostal Block n = 31) will be randomized. Randomization was achieved by randomly assigning patients to computer-generated random numbers. It will be explained that patients can receive both intravenous analgesia treatment and both blocks that are thought to be done. Patients will be told to express the degree of postoperative pain in the preoperative preparation room using a numerical scoring scale (NRS) between 0 and 10 (no pain at 0, no pain at 10). The vascular access will be opened in the pre-operative preparation room and 2 mg demizolam will be made. All preoperative cardiac drugs, except antiplatelet and anticoagulants, will be continued until the morning of surgery.
Demographic structures, cardiopulmonary bypass time, aortic cross clamp time, surgical time, ejection / fraction values will be recorded.
Weight and height of patients will be recorded (BMI). Preoperative, blood group and typing, full hemogram, liver function tests, renal function tests, chest radiography, electrocardiography, 2D transthoracic echocardiography and coronary angiography will be done as routine investigations.
Platelet count, bleeding time, clotting time, prothrombin time, activated partial thromboplastin time will be checked in all patients.
Constructional blocks:
- ESP (Erector Spina Plane) Block Group
- 2. Parasternal Block Group
- Control Group The control group will not receive any Erector Spina block and Paravertebral Block. Only PCA (Patient Control Analgesia) and intravenous analgesic (Morphine) drug will be used.
The same surgical and anesthesia team will manage the patients. 6 channel ECG and non-invasive arterial pressure monitoring will be performed after the patients are admitted to the operation room. A peripheral intravenous line with a 16-gauge needle and a right radial artery with a 20-gauge needle will be performed. Blood will be taken for preoperative blood gas. Midazolam 0.01 (mg / kg), fentanyl (5-8 μg / kg) and rocuronium (0.6 mg / kg) will be used for induction of anesthesia. After anesthesia, central venous catheter and urinary catheter will be inserted. During general anesthesia Sevoflurane will be used in the air-oxygen mixture with a concentration of 50% oxygen. Normocapnic variation will be provided (PCO2 = 35-45). A rocuronium 0.6 mg / kg will be used every 30 minutes. All patients will undergo median sternotomy. Heparin 300-500 Units / kg to be administered. Activeted clotting time (ACT) will be kept> 400 throughout the procedure. Esophageal temperature will be monitored. The mean arterial pressure throughout the operation will be maintained above 60 mm Hg. Peroperative blood sample will be taken from the radial artery 3-5 minutes after the cross-clamp is removed. Heparin will be neutralized with protamine 1: 1.3. After the operation, patients will be transferred to the intensive care unit.
In the intensive care unit, patients will be extubated when the respiratory effort occurs, when the patient is awake, blood gas values are within normal range, body temperature is normal and hemodynamically stable. Morphine consumption by PCA and NRS scores will be monitored and recorded at 1, 3, 6, 12 and 24 hours after extübation. MAP (Mean arterial pressure), PH, PO2 (Blood gas) follow-ups will be recorded in the first blood gas, extubation and postoperative 1,2, 4,6,12, 24 hours.Paracetamol 1 g and Tramadol 1mg/kg intravenously will be administered to the patient if NRS> 3 when the patient is extubated.
If the patient's consciousness and hemodynamic status do not allow pain assessment, the patient will be excluded from the study. After the surgery, the investigator who evaluates NRS scores in the ICU will not know which group the patient is.
Oral feeding at postoperative hour, intensive care unit stay day, Side effects Nausea, Vomiting, Itching to be followed
- Conditions
- Morphine Consumption, Pain, Postoperative
- Being tested
- Erector spina plane block
- Keywords
- Erector Spinae Block, Parasternal block, Cardiac surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spina plane blockOther
While the patient is in the sitting position, an area containing 2 cm lateral of the T5 spinous process will be cleaned with povidone iodine. A high frequency ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle.
| Study group | Role | What they receive |
|---|---|---|
| Group C | No intervention | PCA (Patient controlled analgesia) and morphine consumption will be monitored in the postoperative period. |
| Group ES (Erector Spina Plane) | Active comparator | A high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle. A dose of 0.25% bupivacaine will be injected which is shown to spread both above and below the T5 level. The same process will be implemented on the other side. Receives: Other: Erector spina plane block |
| Group PS (Para Sternal Block) | Active comparator | Before the wire is inserted into the sternum, the sternotomy and mediastinal tube regions will be infiltrated with a mixture of bupivacaine and saline. Receives: Other: Erector spina plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption by PCA
Morphine consumption used in case of pain
Measured: Change from baseline 1 , 3, 6, 12 and 24 hours after extubation
Secondary outcomes (3)
Change Pain Scores
NRS (Numeric Rating scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Measured: Time Frame: 1 hour,3 hours, 6 hours, 12 hours, 24 hours after the extubation
Change Blood Gas
PH, PO2
Measured: Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,
Blood Pressure
mean arterial pressure mmHg
Measured: Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start17 Sep 2019
- Primary completion14 Oct 2021
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morphine ConsumptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Orak, Kahramanmaras Sutcu Imam University
- Investigators
- yavuz orak, md, Principal investigator, Kahramanmaraş Sutcu Imam University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090099
- Sponsor's protocol ID
- 2019/14-08
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2019
- Last updated
- 6 Feb 2024
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-GTrialuided Bilateral Erector Spina Block Versus Parasternal Block in Adult Cardiac Surgery: A Prospective, Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT04090099
- Acronym / sponsor ID
- 2019/14-08
- Conditions
- Morphine Consumption, Pain, Postoperative
- Keywords
- Erector Spinae Block, Parasternal block, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 16 Sep 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.
Inadequate pain relief after cardiac surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. The use of special opioid-based analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention, respiratory depression and delayed tracheal extubation. Regional anesthesia techniques such as pectoralis nerve block and serratus anterior block provide analgesia in the sternum and pain relief in the lateral / posterior chest Wall. Erector spinae (ESP) block, a new and simple myofascial block, provides wide multi-dermatomal sensory block. In the T5 spinous process, bilateral ESP block provides analgesia from T2 to T9 sensory level, resulting in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block may provide adequate analgesia for median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Median sternotomy incision and mediastinal tube regions are the major source of pain in patients undergoing cardiac surgery. The anterior and posterior branches of the intercostal nerves give nerves to the sternum. Parasternal local anesthetic infiltration around the sternum is effective in providing early postoperative analgesia and reducing opioid requirements and therefore has positive effects on healing. This simple and fast technique can be used even for anticoagulated patients.
Detailed description
99 patients will be included in the study. Group C (Control, n = 31), Group ES (Erector Spina, n = 31), Group PS (Parasternal Intercostal Block n = 31) will be randomized. Randomization was achieved by randomly assigning patients to computer-generated random numbers. It will be explained that patients can receive both intravenous analgesia treatment and both blocks that are thought to be done. Patients will be told to express the degree of postoperative pain in the preoperative preparation room using a numerical scoring scale (NRS) between 0 and 10 (no pain at 0, no pain at 10). The vascular access will be opened in the pre-operative preparation room and 2 mg demizolam will be made. All preoperative cardiac drugs, except antiplatelet and anticoagulants, will be continued until the morning of surgery.
Demographic structures, cardiopulmonary bypass time, aortic cross clamp time, surgical time, ejection / fraction values will be recorded.
Weight and height of patients will be recorded (BMI). Preoperative, blood group and typing, full hemogram, liver function tests, renal function tests, chest radiography, electrocardiography, 2D transthoracic echocardiography and coronary angiography will be done as routine investigations.
Platelet count, bleeding time, clotting time, prothrombin time, activated partial thromboplastin time will be checked in all patients.
Constructional blocks:
- ESP (Erector Spina Plane) Block Group
- 2. Parasternal Block Group
- Control Group The control group will not receive any Erector Spina block and Paravertebral Block. Only PCA (Patient Control Analgesia) and intravenous analgesic (Morphine) drug will be used.
The same surgical and anesthesia team will manage the patients. 6 channel ECG and non-invasive arterial pressure monitoring will be performed after the patients are admitted to the operation room. A peripheral intravenous line with a 16-gauge needle and a right radial artery with a 20-gauge needle will be performed. Blood will be taken for preoperative blood gas. Midazolam 0.01 (mg / kg), fentanyl (5-8 μg / kg) and rocuronium (0.6 mg / kg) will be used for induction of anesthesia. After anesthesia, central venous catheter and urinary catheter will be inserted. During general anesthesia Sevoflurane will be used in the air-oxygen mixture with a concentration of 50% oxygen. Normocapnic variation will be provided (PCO2 = 35-45). A rocuronium 0.6 mg / kg will be used every 30 minutes. All patients will undergo median sternotomy. Heparin 300-500 Units / kg to be administered. Activeted clotting time (ACT) will be kept> 400 throughout the procedure. Esophageal temperature will be monitored. The mean arterial pressure throughout the operation will be maintained above 60 mm Hg. Peroperative blood sample will be taken from the radial artery 3-5 minutes after the cross-clamp is removed. Heparin will be neutralized with protamine 1: 1.3. After the operation, patients will be transferred to the intensive care unit.
In the intensive care unit, patients will be extubated when the respiratory effort occurs, when the patient is awake, blood gas values are within normal range, body temperature is normal and hemodynamically stable. Morphine consumption by PCA and NRS scores will be monitored and recorded at 1, 3, 6, 12 and 24 hours after extübation. MAP (Mean arterial pressure), PH, PO2 (Blood gas) follow-ups will be recorded in the first blood gas, extubation and postoperative 1,2, 4,6,12, 24 hours.Paracetamol 1 g and Tramadol 1mg/kg intravenously will be administered to the patient if NRS> 3 when the patient is extubated.
If the patient's consciousness and hemodynamic status do not allow pain assessment, the patient will be excluded from the study. After the surgery, the investigator who evaluates NRS scores in the ICU will not know which group the patient is.
Oral feeding at postoperative hour, intensive care unit stay day, Side effects Nausea, Vomiting, Itching to be followed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –PCA (Patient controlled analgesia) and morphine consumption will be monitored in the postoperative period. |
| Group ES (Erector Spina Plane) | Active comparator | Other: Erector spina plane blockA high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle. A dose of 0.25% bupivacaine will be injected which is shown to spread both above and below the T5 level. The same process will be implemented on the other side. |
| Group PS (Para Sternal Block) | Active comparator | Other: Erector spina plane blockBefore the wire is inserted into the sternum, the sternotomy and mediastinal tube regions will be infiltrated with a mixture of bupivacaine and saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and / or female patients
- Aged 18-65 years
- Patients who will have coronary artery surgery under cardiopulmonary baypass (changing one, two and three vessels) with normal left ventricular function,
- Valve diseases with normal left ventricular function,
- ASD (Atrial Septal Defect) cases for atrial septal defect closure
Key exclusion criteria (13 listed)
- Emergency and repeat heart surgery cases
- Advanced left coronary artery disease and left ventricular dysfunction
- Receiving preoperative inotropic support therapy,
- With mitral stenosis with atrial tombus,
- With low cardiac out put syndrome,
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 spina plane blockWhile the patient is in the sitting position, an area containing 2 cm lateral of the T5 spinous process will be cleaned with povidone iodine. A high frequency ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle. | Other | Group ES (Erector Spina Plane), Group PS (Para Sternal Block) |
Primary outcome
Morphine consumption by PCA
Time frame: Change from baseline 1 , 3, 6, 12 and 24 hours after extubation
Morphine consumption used in case of pain
3 secondary outcomes
Change Pain Scores
Time frame: Time Frame: 1 hour,3 hours, 6 hours, 12 hours, 24 hours after the extubation
Change Blood Gas
Time frame: Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,
Blood Pressure
Time frame: Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after extübation ,
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 6 Feb 2024.
- 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.
yavuz orak, md principal investigator
Kahramanmaraş Sutcu Imam University Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spina plane block in people with Morphine Consumption and Pain, Postoperative, run by Kahramanmaras Sutcu Imam University at 2 sites 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 7 inclusion and 13 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 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Morphine consumption by PCA (time frame: Change from baseline 1 , 3, 6, 12 and 24 hours after extubation). 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 6 Feb 2024.