Morphine ConsumptionNCT06002867
Serratus Anterior Plan Block and Postoperative Pain in Patients Who Underwent Minimally Invasive Cardiac Surgery
A study testing SAPB (Serratus Anterior Plan) Block in people with Morphine Consumption and Pain, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Acute postoperative pain is defined as sudden onset pain that develops after stimulation due to surgical intervention. It is most severe in the first 24 hours after surgery and gradually decreases in severity and creates dissatisfaction in the patient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morphine Consumption, Pain
- What is being tested?
- SAPB (Serratus Anterior Plan) Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 10 Apr 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65,
- Coronary artery patients with normal left ventricular function and scheduled for elective coronary artery bypass surgery,
- Valve diseases for which elective valve replacement is planned with normal left ventricular function,
- Cases of ASD (Atrial Septal Defect) for atrial septal defect closure
- Patients who will have elective valve + coronary artery bypass without left ventricular dysfunction and patients who volunteer to participate in the study,
- No coagulation disorder
Show all 9Show fewer
- Patients with a platelet count of more than 100,000,
- Patients with good mental status,
- Patients with an ejection difference value (E/F) above 50% will be included in the study.
Who cannot join
- Cases that will require emergency and repeat heart surgery,
- With advanced left coronary artery disease and left ventricular dysfunction,
- Receiving preoperative inotropic support therapy for any reason,
- Mitral stenosis with atrial thrombus,
- Patients with low cardiac out put syndrome and E/F below 50%,
- Patients who need intra-aortic balloon pump during surgery,
Show all 13Show fewer
- Patients with bleeding and coagulation disorders,
- Patients with hepatic and renal dysfunction,
- Patients with Uncontrolled Diabetes Mellitus and Chronic Obstructive Pulmonary Disease,
- Patients allergic to opioids, analgesics and bupivacaine,
- Patients with atrial fibrillation using anticoagulants,
- Patients with cognitive dysfunction
- Patients who do not want to participate in the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, 46040
About this study
Official title: Investigation of the Effect of Serratus Anterior Plan Block on Postoperative Pain in Patients Who Underwent Minimally Invasive Cardiac Surgery.
Acute postoperative pain is defined as sudden onset pain that develops after stimulation due to surgical intervention. It is most severe in the first 24 hours after surgery and gradually decreases in severity and creates dissatisfaction in the patient. Postoperative pain that cannot be treated properly can cause various systemic effects, prolongation of hospital stay, decrease in patients' quality of life, and development of chronic pain. An increase in blood pressure, heart rate, cardiac irritability and systemic vascular resistance is observed with the sympathetic response due to pain. Increased myocardial workload and oxygen consumption may increase or trigger myocardial ischemia. Pulmonary dysfunction has an important place in the determination of mortality and morbidity after surgery and anesthesia.Especially in patients who have undergone thoracic surgery, pain limits the movements of the thoracic muscles, reducing functional residual capacity and vital capacity.This causes the development of atelectasis in the patient and the development of hypoxia and pneumonia due to the deterioration of the ventilation/perfusion ratio. Effective analgesia can be achieved in the postoperative period by administering a certain volume of local anesthetic between any two muscle planes using USG. In SAPB, a local anesthetic is injected between the serratus anterior muscle and the latissimus dorsi muscle to create sensory paresthesia in the thoracic wall. It is known to reduce pain scores in the postoperative period.
Serratus anterior plane block is a safe facial plane block performed under USG guidance.Depending on the application site of the block and the amount of local anesthetic administered, different numbers of intercostal nerves, long thoracic nerves and thoracodorsal nerves may be affected. The fact that Serratus anterior plane block (SAPB) is effective between T2-T9 dermatomes enables it to be used effectively in lateral thoracic wall surgeries.
Read the detailed description
Patients between the ages of 18-65 who will undergo minimally invasive cardiac surgery under elective conditions will be included in the study.
Patients will be randomized. The patients will be included in the study after they are informed about the study and their consent is obtained with the patient consent form. Patient groups will be divided into two groups as SAPB Group (n=20) and Control Group (n=20). All patients will be intubated with a double lumen endotracheal intubation tube in accordance with general anesthesia rules. Patients' age, weight, height, body mass index (BMI), additional disease, surgery, medications used, Ejection/Fraction, platelet count (x10/L), cardiopulmonary bypass time (min), aortic cross clamp time (min) , intraoperative remifentanil amount (mcq), intraoperative morphine dose (0.1 mg/kg), postoperative extubation time (min), post extubation, 1. hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour NRS (Numerical Rating Scale) pain score (between 0 and 10, no pain at 0, maximum pain at 10), extubation after, 1st hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour morphine consumption (Patient Controlled Analgesia), how many additional doses paracetamol was administered, how many additional doses were administered, additional analgesic need time (minutes), postoperative hemodynamic monitoring, 1st hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour PH, PO2 (oxygen pressure) ), MAP (mean arterial pressure), will be recorded. In addition, nausea, vomiting, itching, constipation, and the duration of intensive care hospitalization will also be recorded in the postoperative period. The patient will be told to express the degree of postoperative pain using the numerical scoring scale (NRS) before the operation. The patient will be informed about the PCA to be inserted in the postoperative period. After the surgical procedure is completed, serratus anterior plane block will be applied to the patients under the guidance of postoperative USG. After the surgery, the patients will be transferred to the cardiovascular surgery intensive care unit.
Serratus Anterior Plan (SAP) Block:
After the operation is completed, the block operation will be performed while intubated. The patient will be in the supine position.
The area where the procedure will be performed will be cleaned with povidone iodine. With a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath, using the 'in plane' technique using a 22-gauge, 80 mm insulated Quincke type needle, midaxillary line with the latissimus dorsi muscle and serratus at the level of the 4th and 5th ribs. After determining the fascia between the two muscles by imaging the muscle, the block needle will be advanced from caudal to cranial and 40 ml of 0.25% bupivacaine will be injected on the serratus muscle between the two muscles. No block will be applied to the control group. Only the PCA (Patient Control Analgesia) drug with Morphine will be used.
In the intensive care unit, the patients will be extubated after respiratory effort appears, when the patient is awake, blood gas values are within the normal range, body temperature is normal, and hemodynamically stable. When NRS is >3-4, patients will be instructed to press the PCA device. If the patient's consciousness and hemodynamic status do not allow for pain assessment, the patient will be excluded from the study.
- Conditions
- Morphine Consumption, Pain
- Being tested
- SAPB (Serratus Anterior Plan) Block
- Keywords
- Serratus anterior plan block, Postoperative Pain, Minimally Invasive Cardiac Surgery
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPB (Serratus Anterior Plan) BlockProcedure or surgery
The patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. Using a 22-gauge, 80 mm insulated Quincke needle with a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath, the latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs. After determining the fascia between the two muscles, the block needle will be advanced from caudal to cranial and 40 ml of 0.25% bupivacaine (local anesthetic) will be injected on the serratus muscle between the two muscles.
| Study group | Role | What they receive |
|---|---|---|
| Group SAPB (Serratus anterior plane block) | Active comparator | Active Comparator: Group SAPB (Serratus anterior plane block) After the operation is completed, the block operation will be performed while intubated. The patient will be in the supine position.
The area where the procedure will be performed will be cleaned with povidone iodine.
The latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs using a 22-gauge, 80 mm insulated Quincke type needle with the 'in plane' technique, accompanied by a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath. .
After the fascia between the two muscles is fixed, the block needle will be advanced from caudal to cranial and 40 ml (20 ml local anesthetic + 20 ml saline) 0.25% local anesthetic will be injected on the serratus muscle between the two muscles. Receives: Procedure: SAPB (Serratus Anterior Plan) Block |
| Group Control | No intervention | The action will not be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption by PCA (Patient Control Analgesia)
Morphine consumption used in case of pain
Measured: The change from baseline in the postoperative period at the 1, 2, 4, 8, 12 and 24th hour after extubation
Secondary outcomes (5)
pain (NRS)score
Change from baseline NRS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be
Measured: Change from baseline of NRS Score at 1,2, 4,,8, 12 and 24 hours after being extubated will be recorded.
PH
PH change after extubation
Measured: Change from baseline of PH at the 1, 2, 4, 8, 12 and 24th hour after extubation
PO2
PO2 change after extubation
Measured: Change from baseline of PO2 at the 1, 2,4 , 8, 12 and 24th hour after extubation
Mean Arterial Pressure (MAP)
MAP change after extubation
Measured: Change from baseline of MAP at the 1, 2, 4, 8, 12 and 24th hour after extubation
PCO2
PCO2 change after extubation
Measured: Change from baseline of PCO2 change at the 1, 2, 4, 8, 12 and 24th hour after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023
- Primary completion15 Feb 2024
- Study completion10 Apr 2024
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Grup SAPB Grup Control
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 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, Principal investigator, Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi, Anesteziyoloji ve Reanimasyon Bölümü
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002867
- Sponsor's protocol ID
- 2022/16-03
- Status last verified
- Apr 2024
- First submitted
- 31 May 2023
- Last updated
- 17 Apr 2024
- Results posted
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Serratus Anterior Plan Block on Postoperative Pain in Patients Who Underwent Minimally Invasive Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT06002867
- Acronym / sponsor ID
- 2022/16-03
- Conditions
- Morphine Consumption, Pain
- Keywords
- Serratus anterior plan block, Postoperative Pain, Minimally Invasive Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 21 Aug 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.
Acute postoperative pain is defined as sudden onset pain that develops after stimulation due to surgical intervention. It is most severe in the first 24 hours after surgery and gradually decreases in severity and creates dissatisfaction in the patient. Postoperative pain that cannot be treated properly can cause various systemic effects, prolongation of hospital stay, decrease in patients' quality of life, and development of chronic pain. An increase in blood pressure, heart rate, cardiac irritability and systemic vascular resistance is observed with the sympathetic response due to pain. Increased myocardial workload and oxygen consumption may increase or trigger myocardial ischemia. Pulmonary dysfunction has an important place in the determination of mortality and morbidity after surgery and anesthesia.Especially in patients who have undergone thoracic surgery, pain limits the movements of the thoracic muscles, reducing functional residual capacity and vital capacity.This causes the development of atelectasis in the patient and the development of hypoxia and pneumonia due to the deterioration of the ventilation/perfusion ratio. Effective analgesia can be achieved in the postoperative period by administering a certain volume of local anesthetic between any two muscle planes using USG. In SAPB, a local anesthetic is injected between the serratus anterior muscle and the latissimus dorsi muscle to create sensory paresthesia in the thoracic wall. It is known to reduce pain scores in the postoperative period.
Serratus anterior plane block is a safe facial plane block performed under USG guidance.Depending on the application site of the block and the amount of local anesthetic administered, different numbers of intercostal nerves, long thoracic nerves and thoracodorsal nerves may be affected. The fact that Serratus anterior plane block (SAPB) is effective between T2-T9 dermatomes enables it to be used effectively in lateral thoracic wall surgeries.
Detailed description
Patients between the ages of 18-65 who will undergo minimally invasive cardiac surgery under elective conditions will be included in the study.
Patients will be randomized. The patients will be included in the study after they are informed about the study and their consent is obtained with the patient consent form. Patient groups will be divided into two groups as SAPB Group (n=20) and Control Group (n=20). All patients will be intubated with a double lumen endotracheal intubation tube in accordance with general anesthesia rules. Patients' age, weight, height, body mass index (BMI), additional disease, surgery, medications used, Ejection/Fraction, platelet count (x10/L), cardiopulmonary bypass time (min), aortic cross clamp time (min) , intraoperative remifentanil amount (mcq), intraoperative morphine dose (0.1 mg/kg), postoperative extubation time (min), post extubation, 1. hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour NRS (Numerical Rating Scale) pain score (between 0 and 10, no pain at 0, maximum pain at 10), extubation after, 1st hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour morphine consumption (Patient Controlled Analgesia), how many additional doses paracetamol was administered, how many additional doses were administered, additional analgesic need time (minutes), postoperative hemodynamic monitoring, 1st hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour PH, PO2 (oxygen pressure) ), MAP (mean arterial pressure), will be recorded. In addition, nausea, vomiting, itching, constipation, and the duration of intensive care hospitalization will also be recorded in the postoperative period. The patient will be told to express the degree of postoperative pain using the numerical scoring scale (NRS) before the operation. The patient will be informed about the PCA to be inserted in the postoperative period. After the surgical procedure is completed, serratus anterior plane block will be applied to the patients under the guidance of postoperative USG. After the surgery, the patients will be transferred to the cardiovascular surgery intensive care unit.
Serratus Anterior Plan (SAP) Block:
After the operation is completed, the block operation will be performed while intubated. The patient will be in the supine position.
The area where the procedure will be performed will be cleaned with povidone iodine. With a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath, using the 'in plane' technique using a 22-gauge, 80 mm insulated Quincke type needle, midaxillary line with the latissimus dorsi muscle and serratus at the level of the 4th and 5th ribs. After determining the fascia between the two muscles by imaging the muscle, the block needle will be advanced from caudal to cranial and 40 ml of 0.25% bupivacaine will be injected on the serratus muscle between the two muscles. No block will be applied to the control group. Only the PCA (Patient Control Analgesia) drug with Morphine will be used.
In the intensive care unit, the patients will be extubated after respiratory effort appears, when the patient is awake, blood gas values are within the normal range, body temperature is normal, and hemodynamically stable. When NRS is >3-4, patients will be instructed to press the PCA device. If the patient's consciousness and hemodynamic status do not allow for pain assessment, the patient will be excluded from the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Grup SAPB Grup Control
| Arm | Type | Receives |
|---|---|---|
| Group SAPB (Serratus anterior plane block) | Active comparator | Procedure: SAPB (Serratus Anterior Plan) BlockActive Comparator: Group SAPB (Serratus anterior plane block) After the operation is completed, the block operation will be performed while intubated. The patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. The latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs using a 22-gauge, 80 mm insulated Quincke type needle with the 'in plane' technique, accompanied by a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath. . After the fascia between the two muscles is fixed, the block needle will be advanced from caudal to cranial and 40 ml (20 ml local anesthetic + 20 ml saline) 0.25% local anesthetic will be injected on the serratus muscle between the two muscles. |
| Group Control | No intervention | –The action will not be applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between the ages of 18-65,
- Coronary artery patients with normal left ventricular function and scheduled for elective coronary artery bypass surgery,
- Valve diseases for which elective valve replacement is planned with normal left ventricular function,
- Cases of ASD (Atrial Septal Defect) for atrial septal defect closure
- Patients who will have elective valve + coronary artery bypass without left ventricular dysfunction and patients who volunteer to participate in the study,
Key exclusion criteria (13 listed)
- Cases that will require emergency and repeat heart surgery,
- With advanced left coronary artery disease and left ventricular dysfunction,
- Receiving preoperative inotropic support therapy for any reason,
- Mitral stenosis with atrial thrombus,
- Patients with low cardiac out put syndrome and E/F below 50%,
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 |
|---|---|---|
| SAPB (Serratus Anterior Plan) BlockThe patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. Using a 22-gauge, 80 mm insulated Quincke needle with a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath, the latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs. After determining the fascia between the two muscles, the block needle will be advanced from caudal to cranial and 40 ml of 0.25% bupivacaine (local anesthetic) will be injected on the serratus muscle between the two muscles. | Procedure or surgery | Group SAPB (Serratus anterior plane block) |
Primary outcome
Morphine consumption by PCA (Patient Control Analgesia)
Time frame: The change from baseline in the postoperative period at the 1, 2, 4, 8, 12 and 24th hour after extubation
Morphine consumption used in case of pain
5 secondary outcomes
pain (NRS)score
Time frame: Change from baseline of NRS Score at 1,2, 4,,8, 12 and 24 hours after being extubated will be recorded.
PH
Time frame: Change from baseline of PH at the 1, 2, 4, 8, 12 and 24th hour after extubation
PO2
Time frame: Change from baseline of PO2 at the 1, 2,4 , 8, 12 and 24th hour after extubation
Mean Arterial Pressure (MAP)
Time frame: Change from baseline of MAP at the 1, 2, 4, 8, 12 and 24th hour after extubation
PCO2
Time frame: Change from baseline of PCO2 change at the 1, 2, 4, 8, 12 and 24th hour after extubation
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 17 Apr 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 principal investigator
Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi, Anesteziyoloji ve Reanimasyon Bölümü
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAPB (Serratus Anterior Plan) Block in people with Morphine Consumption and Pain, run by Kahramanmaras Sutcu Imam University 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 9 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 17 Apr 2024. 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?
Morphine consumption by PCA (Patient Control Analgesia) (time frame: The change from baseline in the postoperative period at the 1, 2, 4, 8, 12 and 24th hour 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 17 Apr 2024.