Postoperative PainNCT06387095
Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy
A study testing 1. no block, 2. superficial parasternal block and 3. deep parasternal block in people with Postoperative Pain, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- 1. no block, 2. superficial parasternal block and 3. deep parasternal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Aug 2025
- 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
- Performing median sternotomy
- Elective case
- Over 18 years of age; under 80 years of age
- ASA II-III patients
Who cannot join
- Emergency cases
- Patients undergoing minimally invasive surgery
- Patients with a history of opioid use in the last 30 days
- Redo cases
- Patients with left ventricular ejection fraction less than 30%
- Patients with severe hepatic or renal insufficiency
- Patients with chronic pain before surgery (migraine, fibromyalgia)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kosuyolu High Education and Training Hospital
Istanbul, Kartal
münire deniz, +905556461015, muniredeniz.md@gmail.com
ömer savluk, +905056877440, dromersavluk@hotmail.com
About this study
Official title: Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy: Randomized, Controlled Study
Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy.
Read the detailed description
The study will proceed in three arms. The first group is the control group and will receive total intravenous anaesthesia as infusion after peroperative induction until the patient leaves the operating room. The second group will receive ultrasound-guided parasternal superficial plan block after induction. The third group will receive ultrasound-guided parasternal deep plan block. Extubation times, additional analgesic needs, pain scores, intensive care unit duration and hospital discharge times will be compared in the three groups during intensive care unit follow-up. After extubation, patient-controlled analgesia will be applied for 24 hours (with pca infusion pump device).
- Conditions
- Postoperative Pain
- Being tested
- 1. no block, 2. superficial parasternal block, 3. deep parasternal block
- Keywords
- postoperative pain, parasternal blocks, chronic pain, acute pain, cabg
- Medical subject headings
- Pain, Postoperative, Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. no blockProcedure or surgery
Also called intravenous analgesia
After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.
2. superficial parasternal blockProcedure or surgery
Also called intravenous analgesia, regional analjesia
After induction, the patient will undergo an ultrasound-guided superficial parasternal plan block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.
3. deep parasternal blockProcedure or surgery
Also called intravenous analgesia, regional analjesia
After induction, the patient will undergo an ultrasound-guided deep parasternal plane block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| 1. control group | Active comparator | control group. block will not be applied to this group and the patient's analgesia needs will be provided with patient-controlled analgesia devices. Receives: Procedure: 1. no block |
| 2. superficial parasternal plane block group | Active comparator | superficial parasternal plane block group. superficial paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs. Receives: Procedure: 2. superficial parasternal block |
| 3. deep parasternal plane block group | Active comparator | deep parasternal plane block group. deep paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs. Receives: Procedure: 3. deep parasternal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative chronic pain
Determination the effect of parasternal blocks on the incidence for chronic pain at 6 months postoperative period in cardiac surgery. The s-lanss scores of the patients at the 6th postoperative month will be evaluated. The range of the questionnaire is 0-24 and patients with a score above 12 will be considered to have neuropathic pain.
Measured: 6 months
Secondary outcomes (3)
postoperative 24 hours acute pain
postoperative 24 hours pain of the patients will be evaluated with VAS (visual analogue scale). analgesic needs of the patients in the first 24 hours postoperatively will be calculated as morphine equivalent dose using PCA device. At the end of the 24th hour, BPI (brief pain index) will be evaluated. additional analgesic needs of the patients (NSAID, narcotic), if any, will be recorded. it will be evaluated whether there is a significant difference between the VAS scores, analgesic needs and BPI scores in the first 24 hours pain according to the groups.
Measured: 24 hours
extubation time
Extubation time (defined as the time from admission to intensive care unit until extubation) will be evaluated for differences between the groups.the control group
Measured: 24 hours
icu time
The study will look at whether intensive care and hospital discharge times differ between the groups.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Feb 2024
- Primary completion16 Apr 2024
- Study completion1 Aug 2025 (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.
- 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
- Crossover
- Model description
- randomized controlled
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, münire deniz, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Investigators
- munire deniz, Study director, kosuyolu high education and training center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387095
- Sponsor's protocol ID
- 2024/01/756
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 26 Apr 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy: Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06387095
- Acronym / sponsor ID
- 2024/01/756
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, parasternal blocks, chronic pain, acute pain, cabg
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 26 Apr 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.
Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy.
Detailed description
The study will proceed in three arms. The first group is the control group and will receive total intravenous anaesthesia as infusion after peroperative induction until the patient leaves the operating room. The second group will receive ultrasound-guided parasternal superficial plan block after induction. The third group will receive ultrasound-guided parasternal deep plan block. Extubation times, additional analgesic needs, pain scores, intensive care unit duration and hospital discharge times will be compared in the three groups during intensive care unit follow-up. After extubation, patient-controlled analgesia will be applied for 24 hours (with pca infusion pump device).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| 1. control group | Active comparator | Procedure: 1. no blockcontrol group. block will not be applied to this group and the patient's analgesia needs will be provided with patient-controlled analgesia devices. |
| 2. superficial parasternal plane block group | Active comparator | Procedure: 2. superficial parasternal blocksuperficial parasternal plane block group. superficial paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs. |
| 3. deep parasternal plane block group | Active comparator | Procedure: 3. deep parasternal blockdeep parasternal plane block group. deep paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Performing median sternotomy
- Elective case
- Over 18 years of age; under 80 years of age
- ASA II-III patients
Key exclusion criteria (7 listed)
- Emergency cases
- Patients undergoing minimally invasive surgery
- Patients with a history of opioid use in the last 30 days
- Redo cases
- Patients with left ventricular ejection fraction less than 30%
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 |
|---|---|---|
| 1. no blockAlso: intravenous analgesiaAfter extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded. | Procedure or surgery | 1. control group |
| 2. superficial parasternal blockAlso: intravenous analgesia, regional analjesiaAfter induction, the patient will undergo an ultrasound-guided superficial parasternal plan block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded. | Procedure or surgery | 2. superficial parasternal plane block group |
| 3. deep parasternal blockAlso: intravenous analgesia, regional analjesiaAfter induction, the patient will undergo an ultrasound-guided deep parasternal plane block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded. | Procedure or surgery | 3. deep parasternal plane block group |
Primary outcome
postoperative chronic pain
Time frame: 6 months
Determination the effect of parasternal blocks on the incidence for chronic pain at 6 months postoperative period in cardiac surgery. The s-lanss scores of the patients at the 6th postoperative month will be evaluated. The range of the questionnaire is 0-24 and patients with a score above 12 will be considered to have neuropathic pain.
3 secondary outcomes
postoperative 24 hours acute pain
Time frame: 24 hours
extubation time
Time frame: 24 hours
icu time
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
munire deniz study director
kosuyolu high education and training center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. no block, 2. superficial parasternal block and 3. deep parasternal block in people with Postoperative Pain, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 26 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact omer savluk (+905056877440, dromersavluk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative chronic pain (time frame: 6 months). 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 26 Apr 2024.