Nerve BlockNCT06709625
Comparison of Erector Spinae Plane Block and Transversus Thoracic Muscle Plane Block in Coronary Artery Surgery
A study testing Transversus thoracis plane block and Erector spina plane block (ESP) in people with Nerve Block and Coronary Artery Bypass, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The main objective of this study is to evaluate postoperative pain intensity comparatively between erector spinae plane block and transversus thoracic muscle plane block in patients undergoing open coronary artery surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nerve Block, Coronary Artery Bypass, Anesthesia and Analgesia
- What is being tested?
- Transversus thoracis plane block and Erector spina plane block (ESP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 who will undergo elective coronary artery surgery in TR Ankara City Hospital cardiovascular surgery operating room will be included in the study.
Who cannot join
- Exclusion criteria for patients aged 18-80 who will undergo isolated coronary artery bypass surgery
- Non-coronary artery surgery cases
- Re-operations
- Low EF (<40%)
- psychiatric illness
- Those who have contraindications for block (infection at the block site, etc.)
- Patients who do not or cannot give consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06530
About this study
Official title: Comparison of the Effects of Erector Spinae Plane Block and Transversus Thoracis Muscle Plane Block on Postoperative Recovery in Patients Undergoing Coronary Artery Surgery
The main objective of this study is to evaluate postoperative pain intensity comparatively between erector spinae plane block and transversus thoracic muscle plane block in patients undergoing open coronary artery surgery. The primary question it aims to address is which of these two regional techniques causes less postoperative pain.
Read the detailed description
Primary aim in this study is to evaluate the postoperative pain severity of erector spina plane block in comparison with transversus thorasis muscle plane block in patients undergoing open coronary artery surgery. Secondary aim is to retrospectively evaluate the analgesic requirements, complications, extubation times, mortality and morbidity of these patients.
The study will be designed as a prospective randomized controlled trial. After ethics committee approval is obtained, the regional anesthesia method to be applied to 60 patients who are planned to undergo coronary artery surgery in the TR Ministry of Health Ankara City Hospital Cardiovascular Surgery Operating Room and who do not have exclusion criteria will be determined according to the closed envelope method, erector spina plan and transversus thorasis muscle plan (two groups) and will be reported to the anesthesiologist.
Patients who will undergo bilateral erector spinae plane block will be taken to the operating room non-premedicated. In the operating room, after ASA monitoring, intra-arterial, BIS, NIRS monitoring, anesthesia induction with propofol 1-3 mg/kg, fentanyl 2 µg/kg and rocuronium 0.6 mg/kg, endotracheal intubation will be performed, central vein catheterization, urinary catheter and nasopharyngeal temperature probe will be placed. . After the patient is placed in the prone position by the same experienced researcher, appropriate sterilization conditions for the skin and equipment are provided, the USG probe will be fixed on the transverse process in the area where the block is desired, and a 22 gauge 80 mm block needle will be placed parallel to the longitudinal axis. The bone structure will be reached by viewing the needle with an in plane technique at an angle of approximately 45 degrees and advancing it to the posterior of the transverse process. When the needle tip is in the appropriate position under the erector spinae muscle, intermittent aspiration will be performed to confirm that there is no vascular puncture. Following negative aspiration, saline is administered and local anesthetic injection is applied after the erector spinae muscle is seen to be separated from the transverse process. For TTP, the same experienced practitioner places the USG probe, which should be placed approximately 2-3 cm lateral to the sternal border, under the same sterile conditions. The T4-T5 intercostal space will then be identified under ultrasound guidance in a parasagittal view, and the nerve block needle is inserted in-plane into the catheter. The needle is then directed into the transversus thoracic muscle plane between this muscle and the internal intercostal muscle. Here, the local anesthetic solution will be given, taking care to aspirate before each injection to avoid intravascular and intrapleural administration.
Anesthesia will be maintained with propofol/oxygen/air mixture and remifentanil 1 mcg/kg/hour. If systolic arterial blood pressure or heart rate increases more than 20% above baseline in response to surgical stimuli, additional fentanyl 2 µg/kg increments will be administered.
IV tramadol PCA bolus 10mg will be prepared for each patient with a lock-in time of 20 minutes and its use will be explained to the patients in the preoperative period. The total dose of madol used will be monitored.
At the end of the surgery, patients will be taken to intensive care and monitored on a mechanical ventilator. According to standard ICU policy, extubation will be performed at the earliest clinically appropriate time. Patients will be monitored in intensive care for 24 hours after extubation. In the ICU, VAS and BPS will be used to evaluate pain. When VAS is greater than 4 and BPS is greater than 3, additional analgesia will be given.
Induction and maintenance anesthetic drugs and dosages, analgesic drugs and dosages (15mg/kg every 8 hours after routine paracetamol, analgesic need with PCA device, total doses, before and after anesthesia induction, after skin incision, after sternotomy, after 30 hours after leaving CPB Minutes later and after closing the sternum, heart rate (beats/min) and systolic arterial pressure (mmHg) will be measured. 0, 4, 8, 12, 24 hours after postoperative extubation, respiratory rate (respiratory rate/min) and from ICU arrival to endotracheal extubation. Extubation time (minutes) defined as the time from extubation to first rescue analgesia (hours), pain problems: time from extubation to first rescue analgesia (hours), VAS and BPS scores at 0, 4, 8, 12, 24 hours after extubation, postoperative pain at rest and sternal Complications associated with the non-pain block will be recorded.
Sample size calculation was performed using MedCalc 15.8 (MedCalc Software bvba, Ostend, Belgium). It was determined that a minimum 60 patient (30+30) was sufficient for 90% (1-β) power.
- Being tested
- Transversus thoracis plane block, Erector spina plane block (ESP)
- Keywords
- Erector spina plane block, Transversus thoracic plane block, Cardiothoracic surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus thoracis plane blockProcedure or surgery
Transversus thoracis plane block will be applied to provide postoperative analgesia.
Erector spina plane block (ESP)Procedure or surgery
Erector spina plane block will be applied to provide postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Group of patients who underwent erector spinae plane block | Active comparator | 20 ml %0.25 bupivacaine solution will be given under the erector spinae muscle under USG guidance in the prone position and intraoperative and postoperative data will be recorded. Receives: Procedure: Erector spina plane block (ESP) |
| Group of patients who undervent transversus thoracic plane block | Active comparator | 20ml %0.25 bupivacaine solution will be given between the transversus thoracis muscle and the internal intercostal muscle under USG guidance in the supin position and intraoperative and postoperative data will be recorded. Receives: Procedure: Transversus thoracis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.
VAS values will be recorded
Measured: postoperatively 0, 4, 8, 12 and 24 hours
To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.
BPS values will be recorded
Measured: postoperatively 0, 4, 8, 12 and 24 hours
To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.
Rescue analgesic dosages will be recorded
Measured: postoperatively 0, 4, 8, 12 and 24 hours
To evaluate the effects of erector spinae plane block on postoperative hemonidamy in patients undergoing open coronary artery surgery, in comparison with transversus thoracis muscle plane block.
Systolic arterial pressure will be recorded
Measured: postoperatively 0, 4, 8, 12 and 24 hours
Secondary outcomes (7)
Determine the incidence of block-related adverse events
Measured: Neurological or cardiovascular events occurring within the first 30 minutes after block application will be monitored to evaluate local anesthesia toxicity.
Determine the incidence of block-related adverse events
Measured: Chest wall hematoma and pneumothorax are diagnosed by USG after block and before skin incision within the first 24 hours after block applications
To record the incidence of other side effects due to opioid administration
t will be questioned whether there is itching or not
Measured: Postoperatively 0, 2, 4, 8, 12, 24 hours
To record the incidence of other side effects due to opioid administration
t will be questioned whether there is nausea or not
Measured: Postoperatively 0, 2, 4, 8, 12, 24 hours
To record the incidence of other side effects due to opioid administration
t will be questioned whether there is vomiting or not
Measured: Postoperatively 0, 2, 4, 8, 12, 24 hours
Evaluation of intraoperative hemodynamic changes between two blocks
Measured: Heart rate (beats/min) will be measured before and 1minute later after anesthesia induction, 1minute later after skin incision, 1minute later after sternotomy, 30 minutes after weaning from CPB, and 1minute later after sternum closure.
Evaluation of intraoperative hemodynamic changes between two blocks
Systolic arterial pressure (mmHg) will be measured before and after anesthesia induction, after skin incision, after sternotomy, 30 minutes after weaning from CPB, and after sternum closure.
Measured: Before and 1minute later after anesthesia induction, 1minute later after skin incision, 1minute later after sternotomy, 30 minutes after weaning from CPB, and 1minute later after sternum closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Sep 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nevriye Salman, Principal investigator, ankara bilkent city hospital, anesthesiology and reanimation clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709625
- Sponsor's protocol ID
- NigarAltindag1
- Status last verified
- Nov 2024
- First submitted
- 12 Feb 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
PubMed 28564673Zubrzycki M, Liebold A, Skrabal C, Reinelt H, Ziegler M, Perdas E, Zubrzycka M. Assessment and pathophysiology of pain in cardiac surgery. J Pain Res. 2018 Aug 24;11:1599-1611. doi: 10.2147/JPR.S162067. eCollection 2018.
PubMed 30197534Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
PubMed 10927999Barr LF, Boss MJ, Mazzeffi MA, Taylor BS, Salenger R. Postoperative Multimodal Analgesia in Cardiac Surgery. Crit Care Clin. 2020 Oct;36(4):631-651. doi: 10.1016/j.ccc.2020.06.003. Epub 2020 Aug 12.
PubMed 32892818Cosarcan SK, Sezer OA, Gurkahraman S, Ercelen O. Regional analgesia techniques for effective recovery from coronary artery bypass surgeries: a retrospective study involving the experience of a single center. J Cardiothorac Surg. 2022 Jul 6;17(1):170. doi: 10.1186/s13019-022-01923-6.
PubMed 35794614Gregory AJ, Grant MC, Manning MW, Cheung AT, Ender J, Sander M, Zarbock A, Stoppe C, Meineri M, Grocott HP, Ghadimi K, Gutsche JT, Patel PA, Denault A, Shaw A, Fletcher N, Levy JH. Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) Recommendations: An Important First Step-But There Is Much Work to Be Done. J Cardiothorac Vasc Anesth. 2020 Jan;34(1):39-47. doi: 10.1053/j.jvca.2019.09.002. Epub 2019 Sep 7. No abstract available.
PubMed 31570245King M, Stambulic T, Hassan SMA, Norman PA, Derry K, Payne DM, El Diasty M. Median sternotomy pain after cardiac surgery: To block, or not? A systematic review and meta-analysis. J Card Surg. 2022 Nov;37(11):3729-3742. doi: 10.1111/jocs.16882. Epub 2022 Sep 13.
PubMed 36098374Cogan J. Pain management after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Sep;14(3):201-4. doi: 10.1177/1089253210378401.
PubMed 20705642Ritter MJ, Christensen JM, Yalamuri SM. Regional Anesthesia for Cardiac Surgery: A Review of Fascial Plane Blocks and Their Uses. Adv Anesth. 2021 Dec;39:215-240. doi: 10.1016/j.aan.2021.08.001. Epub 2021 Oct 1. No abstract available.
PubMed 34715976Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
PubMed 32032103Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.
PubMed 36581838
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Erector Spinae Plane Block and Transversus Thoracis Muscle Plane Block on Postoperative Recovery in Patients Undergoing Coronary Artery Surgery
- ClinicalTrials.gov ID
- NCT06709625
- Acronym / sponsor ID
- NigarAltindag1
- Keywords
- Erector spina plane block, Transversus thoracic plane block, Cardiothoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 29 Nov 2024 (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.
The main objective of this study is to evaluate postoperative pain intensity comparatively between erector spinae plane block and transversus thoracic muscle plane block in patients undergoing open coronary artery surgery. The primary question it aims to address is which of these two regional techniques causes less postoperative pain.
Detailed description
Primary aim in this study is to evaluate the postoperative pain severity of erector spina plane block in comparison with transversus thorasis muscle plane block in patients undergoing open coronary artery surgery. Secondary aim is to retrospectively evaluate the analgesic requirements, complications, extubation times, mortality and morbidity of these patients.
The study will be designed as a prospective randomized controlled trial. After ethics committee approval is obtained, the regional anesthesia method to be applied to 60 patients who are planned to undergo coronary artery surgery in the TR Ministry of Health Ankara City Hospital Cardiovascular Surgery Operating Room and who do not have exclusion criteria will be determined according to the closed envelope method, erector spina plan and transversus thorasis muscle plan (two groups) and will be reported to the anesthesiologist.
Patients who will undergo bilateral erector spinae plane block will be taken to the operating room non-premedicated. In the operating room, after ASA monitoring, intra-arterial, BIS, NIRS monitoring, anesthesia induction with propofol 1-3 mg/kg, fentanyl 2 µg/kg and rocuronium 0.6 mg/kg, endotracheal intubation will be performed, central vein catheterization, urinary catheter and nasopharyngeal temperature probe will be placed. . After the patient is placed in the prone position by the same experienced researcher, appropriate sterilization conditions for the skin and equipment are provided, the USG probe will be fixed on the transverse process in the area where the block is desired, and a 22 gauge 80 mm block needle will be placed parallel to the longitudinal axis. The bone structure will be reached by viewing the needle with an in plane technique at an angle of approximately 45 degrees and advancing it to the posterior of the transverse process. When the needle tip is in the appropriate position under the erector spinae muscle, intermittent aspiration will be performed to confirm that there is no vascular puncture. Following negative aspiration, saline is administered and local anesthetic injection is applied after the erector spinae muscle is seen to be separated from the transverse process. For TTP, the same experienced practitioner places the USG probe, which should be placed approximately 2-3 cm lateral to the sternal border, under the same sterile conditions. The T4-T5 intercostal space will then be identified under ultrasound guidance in a parasagittal view, and the nerve block needle is inserted in-plane into the catheter. The needle is then directed into the transversus thoracic muscle plane between this muscle and the internal intercostal muscle. Here, the local anesthetic solution will be given, taking care to aspirate before each injection to avoid intravascular and intrapleural administration.
Anesthesia will be maintained with propofol/oxygen/air mixture and remifentanil 1 mcg/kg/hour. If systolic arterial blood pressure or heart rate increases more than 20% above baseline in response to surgical stimuli, additional fentanyl 2 µg/kg increments will be administered.
IV tramadol PCA bolus 10mg will be prepared for each patient with a lock-in time of 20 minutes and its use will be explained to the patients in the preoperative period. The total dose of madol used will be monitored.
At the end of the surgery, patients will be taken to intensive care and monitored on a mechanical ventilator. According to standard ICU policy, extubation will be performed at the earliest clinically appropriate time. Patients will be monitored in intensive care for 24 hours after extubation. In the ICU, VAS and BPS will be used to evaluate pain. When VAS is greater than 4 and BPS is greater than 3, additional analgesia will be given.
Induction and maintenance anesthetic drugs and dosages, analgesic drugs and dosages (15mg/kg every 8 hours after routine paracetamol, analgesic need with PCA device, total doses, before and after anesthesia induction, after skin incision, after sternotomy, after 30 hours after leaving CPB Minutes later and after closing the sternum, heart rate (beats/min) and systolic arterial pressure (mmHg) will be measured. 0, 4, 8, 12, 24 hours after postoperative extubation, respiratory rate (respiratory rate/min) and from ICU arrival to endotracheal extubation. Extubation time (minutes) defined as the time from extubation to first rescue analgesia (hours), pain problems: time from extubation to first rescue analgesia (hours), VAS and BPS scores at 0, 4, 8, 12, 24 hours after extubation, postoperative pain at rest and sternal Complications associated with the non-pain block will be recorded.
Sample size calculation was performed using MedCalc 15.8 (MedCalc Software bvba, Ostend, Belgium). It was determined that a minimum 60 patient (30+30) was sufficient for 90% (1-β) power.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of patients who underwent erector spinae plane block | Active comparator | Procedure: Erector spina plane block (ESP)20 ml %0.25 bupivacaine solution will be given under the erector spinae muscle under USG guidance in the prone position and intraoperative and postoperative data will be recorded. |
| Group of patients who undervent transversus thoracic plane block | Active comparator | Procedure: Transversus thoracis plane block20ml %0.25 bupivacaine solution will be given between the transversus thoracis muscle and the internal intercostal muscle under USG guidance in the supin position and intraoperative and postoperative data will be recorded. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-80 who will undergo elective coronary artery surgery in TR Ankara City Hospital cardiovascular surgery operating room will be included in the study.
Key exclusion criteria (7 listed)
- Exclusion criteria for patients aged 18-80 who will undergo isolated coronary artery bypass surgery
- Non-coronary artery surgery cases
- Re-operations
- Low EF (<40%)
- psychiatric illness
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 |
|---|---|---|
| Transversus thoracis plane blockTransversus thoracis plane block will be applied to provide postoperative analgesia. | Procedure or surgery | Group of patients who undervent transversus thoracic plane block |
| Erector spina plane block (ESP)Erector spina plane block will be applied to provide postoperative analgesia. | Procedure or surgery | Group of patients who underwent erector spinae plane block |
Primary outcome
To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.
Time frame: postoperatively 0, 4, 8, 12 and 24 hours
VAS values will be recorded
To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.
Time frame: postoperatively 0, 4, 8, 12 and 24 hours
BPS values will be recorded
To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.
Time frame: postoperatively 0, 4, 8, 12 and 24 hours
Rescue analgesic dosages will be recorded
To evaluate the effects of erector spinae plane block on postoperative hemonidamy in patients undergoing open coronary artery surgery, in comparison with transversus thoracis muscle plane block.
Time frame: postoperatively 0, 4, 8, 12 and 24 hours
Systolic arterial pressure will be recorded
7 secondary outcomes
Determine the incidence of block-related adverse events
Time frame: Neurological or cardiovascular events occurring within the first 30 minutes after block application will be monitored to evaluate local anesthesia toxicity.
Determine the incidence of block-related adverse events
Time frame: Chest wall hematoma and pneumothorax are diagnosed by USG after block and before skin incision within the first 24 hours after block applications
To record the incidence of other side effects due to opioid administration
Time frame: Postoperatively 0, 2, 4, 8, 12, 24 hours
To record the incidence of other side effects due to opioid administration
Time frame: Postoperatively 0, 2, 4, 8, 12, 24 hours
To record the incidence of other side effects due to opioid administration
Time frame: Postoperatively 0, 2, 4, 8, 12, 24 hours
Evaluation of intraoperative hemodynamic changes between two blocks
Time frame: Heart rate (beats/min) will be measured before and 1minute later after anesthesia induction, 1minute later after skin incision, 1minute later after sternotomy, 30 minutes after weaning from CPB, and 1minute later after sternum closure.
Evaluation of intraoperative hemodynamic changes between two blocks
Time frame: Before and 1minute later after anesthesia induction, 1minute later after skin incision, 1minute later after sternotomy, 30 minutes after weaning from CPB, and 1minute later after sternum closure.
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 29 Nov 2024.
- Results publication: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Results publication: PubMed 28564673Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
- Results publication: PubMed 30197534Zubrzycki M, Liebold A, Skrabal C, Reinelt H, Ziegler M, Perdas E, Zubrzycka M. Assessment and pathophysiology of pain in cardiac surgery. J Pain Res. 2018 Aug 24;11:1599-1611. doi: 10.2147/JPR.S162067. eCollection 2018.
- Results publication: PubMed 10927999Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
- Results publication: PubMed 32892818Barr LF, Boss MJ, Mazzeffi MA, Taylor BS, Salenger R. Postoperative Multimodal Analgesia in Cardiac Surgery. Crit Care Clin. 2020 Oct;36(4):631-651. doi: 10.1016/j.ccc.2020.06.003. Epub 2020 Aug 12.
- Results publication: PubMed 35794614Cosarcan SK, Sezer OA, Gurkahraman S, Ercelen O. Regional analgesia techniques for effective recovery from coronary artery bypass surgeries: a retrospective study involving the experience of a single center. J Cardiothorac Surg. 2022 Jul 6;17(1):170. doi: 10.1186/s13019-022-01923-6.
- Results publication: PubMed 31570245Gregory AJ, Grant MC, Manning MW, Cheung AT, Ender J, Sander M, Zarbock A, Stoppe C, Meineri M, Grocott HP, Ghadimi K, Gutsche JT, Patel PA, Denault A, Shaw A, Fletcher N, Levy JH. Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) Recommendations: An Important First Step-But There Is Much Work to Be Done. J Cardiothorac Vasc Anesth. 2020 Jan;34(1):39-47. doi: 10.1053/j.jvca.2019.09.002. Epub 2019 Sep 7. No abstract available.
- Results publication: PubMed 36098374King M, Stambulic T, Hassan SMA, Norman PA, Derry K, Payne DM, El Diasty M. Median sternotomy pain after cardiac surgery: To block, or not? A systematic review and meta-analysis. J Card Surg. 2022 Nov;37(11):3729-3742. doi: 10.1111/jocs.16882. Epub 2022 Sep 13.
- Results publication: PubMed 20705642Cogan J. Pain management after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Sep;14(3):201-4. doi: 10.1177/1089253210378401.
- Results publication: PubMed 34715976Ritter MJ, Christensen JM, Yalamuri SM. Regional Anesthesia for Cardiac Surgery: A Review of Fascial Plane Blocks and Their Uses. Adv Anesth. 2021 Dec;39:215-240. doi: 10.1016/j.aan.2021.08.001. Epub 2021 Oct 1. No abstract available.
- Results publication: PubMed 32032103Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
- Results publication: PubMed 36581838Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.
- 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.
Nevriye Salman principal investigator
ankara bilkent city hospital, anesthesiology and reanimation clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus thoracis plane block and Erector spina plane block (ESP) in people with Nerve Block and Coronary Artery Bypass, 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 7 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 29 Nov 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?
To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery. (time frame: postoperatively 0, 4, 8, 12 and 24 hours). The study lists 4 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 NCT06709625, which also lists 12 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 29 Nov 2024.