Postoperative PainNCT06267443
Erector Spina Block or Parasternal Block Plus Chest Tube Wound Infiltration for Cardiac Surgeries
A study testing Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia in people with Postoperative Pain and Postoperative Atelectasis, run by TC Erciyes University.
Trial summary
Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Postoperative Atelectasis, Analgesia
- What is being tested?
- Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Aug 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 who will undergo open heart surgery
- Patients who agreed to participate in the study-
Who cannot join
- Patients who do not agree to participate in the study
- Patients with chronic lung disease
- Patients with D. Mellitus
About this study
Official title: Comparison of Two Different Techniques for Postoperative Analgesia in Cardiopulmonary Bypass Surgeries: Erector Spinae Plane Block or Parasternal Block Plus Chest Tube Wound Infiltration
Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas.
Read the detailed description
Patients who will undergo open heart surgery will be included in this study. Pain management is important after coronary artery bypass graft (CABG) surgery. Poorly controlled postoperative pain can trigger myocardial ischemia, increase catecholamine levels, result in increased complications such as stroke and bleeding, and increase the risk of pneumonia. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. For this reason, regional methods are gaining importance in pain treatment. After cardiac surgery. Both sternotomy and bilateral chest tubes are the most painful interventions during cardiac surgeries. Parasternal block can be a good alternative in the treatment of pain in CABG surgeries. In parasternal application, the aim is to anesthetize the nerves innervating the sternum between the pectoral muscle and the intercostal muscle by holding the probe in the parasagittal plane on the lateral side of the sternum under USG guidance. Patients who will undergo open heart surgery will be included in this study. The patients will be divided into two groups, and in Group 1, before general anesthesia is given, bilateral ESPB will be performed at the 4-6th thoracic level in the prone position, and then routine general anesthesia will be performed (at this stage, the patients will be given sedation to prevent them from feeling pain). After endotracheal intubation, in Group 2, a parasternal block will be performed from the lateral sternum. At the end of the surgery, local anesthetic infiltration will be perform to the tube sites. General anesthesia and surgical procedures will be performed routinely in both groups. In the intensive care unit patients will be monitored for pain levels, intubation duration, whether there is atelectasis in the lungs, and the need for reintubation. Pain assessment will be evaluated with the behavioral pain score while the patients are intubated and with the visual pain scale after extubation. Whether atelectasis has developed will be evaluated with ultrasonography at the 12th and 24th hours postoperatively
- Conditions
- Postoperative Pain, Postoperative Atelectasis, Analgesia
- Being tested
- Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia
- Keywords
- CPBGS, postop analgesia, ESPB, parasternal block, local anesthetic
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesiaProcedure or surgery
Group 1: erector spina plane block: With USG guidance at the thoracal level of 4-5, with 20ml 2.5% bupivacaine ESPB will be performed. after surgery in the ICU pain score and atelectasia will be evaluated.
Group 2: With USG guidance parasternal block will be performed after intubation bilaterally with 10 ml 0.25% bupivacaine each side. at the end of the surgery infiltration of chest tube sides will be performed with 10 ml 2.5% bupivacain.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | in this group erector spina plane block will be performed before surgery for post operative analgesia Receives: Procedure: Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia |
| Group 2 | Active comparator | in this group after endotracheal intubation bilateral parasternal block will be performed and to the chest tube sides local anesthetic infiltration will be performed Receives: Procedure: Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesia
postoperatively in the intensive care unit during mechanical ventilation behavioral pain, score, after extubation visüel analog scala will be used to measure postoperative pain of the patients. during mechanical ventilation every 2 hours after extübation 2., 4., 6., 8., 12., 24. hours
Measured: 24 hours after after surgery
postoperative atelectasia
postoperatively at the 12. th and 24.th hours with ultrasonography the patients lungs will be sreened for atelectasis
Measured: 24 hours after after surgery
Secondary outcomes (1)
postoperative mechanical ventilation duration
in the intensive care unit time to endotracheal extubation will be recorded
Measured: 24 hours after after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ulgey, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267443
- Sponsor's protocol ID
- 2023/337
- Status last verified
- Feb 2024
- First submitted
- 25 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Techniques for Postoperative Analgesia in Cardiopulmonary Bypass Surgeries: Erector Spinae Plane Block or Parasternal Block Plus Chest Tube Wound Infiltration
- ClinicalTrials.gov ID
- NCT06267443
- Acronym / sponsor ID
- 2023/337
- Conditions
- Postoperative Pain, Postoperative Atelectasis, Analgesia
- Keywords
- CPBGS, postop analgesia, ESPB, parasternal block, local anesthetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 20 Feb 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.
Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas.
Detailed description
Patients who will undergo open heart surgery will be included in this study. Pain management is important after coronary artery bypass graft (CABG) surgery. Poorly controlled postoperative pain can trigger myocardial ischemia, increase catecholamine levels, result in increased complications such as stroke and bleeding, and increase the risk of pneumonia. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. For this reason, regional methods are gaining importance in pain treatment. After cardiac surgery. Both sternotomy and bilateral chest tubes are the most painful interventions during cardiac surgeries. Parasternal block can be a good alternative in the treatment of pain in CABG surgeries. In parasternal application, the aim is to anesthetize the nerves innervating the sternum between the pectoral muscle and the intercostal muscle by holding the probe in the parasagittal plane on the lateral side of the sternum under USG guidance. Patients who will undergo open heart surgery will be included in this study. The patients will be divided into two groups, and in Group 1, before general anesthesia is given, bilateral ESPB will be performed at the 4-6th thoracic level in the prone position, and then routine general anesthesia will be performed (at this stage, the patients will be given sedation to prevent them from feeling pain). After endotracheal intubation, in Group 2, a parasternal block will be performed from the lateral sternum. At the end of the surgery, local anesthetic infiltration will be perform to the tube sites. General anesthesia and surgical procedures will be performed routinely in both groups. In the intensive care unit patients will be monitored for pain levels, intubation duration, whether there is atelectasis in the lungs, and the need for reintubation. Pain assessment will be evaluated with the behavioral pain score while the patients are intubated and with the visual pain scale after extubation. Whether atelectasis has developed will be evaluated with ultrasonography at the 12th and 24th hours postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesiain this group erector spina plane block will be performed before surgery for post operative analgesia |
| Group 2 | Active comparator | Procedure: Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesiain this group after endotracheal intubation bilateral parasternal block will be performed and to the chest tube sides local anesthetic infiltration will be performed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who will undergo open heart surgery
- Patients who agreed to participate in the study-
Key exclusion criteria (3 listed)
- Patients who do not agree to participate in the study
- Patients with chronic lung disease
- Patients with D. Mellitus
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 |
|---|---|---|
| Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesiaGroup 1: erector spina plane block: With USG guidance at the thoracal level of 4-5, with 20ml 2.5% bupivacaine ESPB will be performed. after surgery in the ICU pain score and atelectasia will be evaluated. Group 2: With USG guidance parasternal block will be performed after intubation bilaterally with 10 ml 0.25% bupivacaine each side. at the end of the surgery infiltration of chest tube sides will be performed with 10 ml 2.5% bupivacain. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
postoperative analgesia
Time frame: 24 hours after after surgery
postoperatively in the intensive care unit during mechanical ventilation behavioral pain, score, after extubation visüel analog scala will be used to measure postoperative pain of the patients. during mechanical ventilation every 2 hours after extübation 2., 4., 6., 8., 12., 24. hours
postoperative atelectasia
Time frame: 24 hours after after surgery
postoperatively at the 12. th and 24.th hours with ultrasonography the patients lungs will be sreened for atelectasis
1 secondary outcome
postoperative mechanical ventilation duration
Time frame: 24 hours after after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia in people with Postoperative Pain and Postoperative Atelectasis, run by TC Erciyes University.
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 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
postoperative analgesia (time frame: 24 hours after after surgery). The study lists 2 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 Feb 2024.