Coronary Artery Bypass SurgeryNCT06882083
The Effect of Paravertebral Block on Recovery After CABG Surgery
A study testing paravertebral block in people with Coronary Artery Bypass Surgery and Paravertebral Block, run by Adiyaman University Research Hospital.
Trial summary
The study aims to evaluate the analgesic efficacy of paravertebral block, mobilization speed, respiratory functions, and complication rates in patients who have undergone cardiac surgery and are monitored in the intensive care unit during the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Surgery, Paravertebral Block
- What is being tested?
- paravertebral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and older scheduled for elective coronary artery bypass graft surgery with median sternotomy
Who cannot join
- Contraindications to neuroaxial block ( coagulopathy, infection at the injection site, allergy to local anesthetics..)
- Emergency surgeries
- severe back deformities
- Chronic pain
- refusal to participate
- CABG without sternotomy
About this study
Official title: The Effect of Ultrasound-Guided Bilateral Single-Shot Paravertebral Block on Recovery After Coronary Artery Bypass Graft Surgery
The study aims to evaluate the analgesic efficacy of paravertebral block, mobilization speed, respiratory functions, and complication rates in patients who have undergone cardiac surgery and are monitored in the intensive care unit during the postoperative period.
Read the detailed description
The aim of this study is to evaluate the effects of a single-dose bilateral paravertebral block administered under ultrasound guidance on the recovery process after cardiac surgery. Effective management of postoperative pain in cardiac surgeries is crucial for enhancing patient comfort, reducing complications, and facilitating rapid recovery. Paravertebral block can be utilized as an effective method for pain management following cardiac surgeries. This technique provides extensive analgesic coverage in the thoracic region while reducing opioid consumption and its associated side effects. Additionally, it supports the preservation of respiratory functions, facilitates early mobilization, and may reduce postoperative complications. When performed under ultrasound guidance, the accuracy and efficacy of the block are enhanced, making it a safe analgesic option in cardiac surgeries. Studies have demonstrated that paravertebral block increases patient satisfaction and contributes positively to the recovery process. Therefore, it is a viable approach for postoperative pain management in cardiac surgery.
This study will be conducted with a prospective, randomized, and controlled design. Patients will be assigned to two groups using a sealed-envelope method: the paravertebral block group and the control group. Patients in the paravertebral block group will receive a single-dose bilateral paravertebral block under ultrasound guidance before the induction of general anesthesia. The block will be performed at an appropriate thoracic level using 20 mL of 0.25% bupivacaine as the local anesthetic. Patients in the control group will receive a standard analgesia protocol.
All patients will be monitored in the intensive care unit during the postoperative period, and the following parameters will be assessed: pain scores using the visual analog scale (VAS), total opioid consumption, extubation times, intensive care unit length of stay, Quality of Recovery-15 (QoR-15) score, and postoperative complications. Data will be collected during the preoperative assessment and throughout the first 48 hours postoperatively.
- Being tested
- paravertebral block
- Keywords
- Paravertebral block, Coronary artery bypass surgery, Quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral blockProcedure or surgery
A single-dose bilateral paravertebral block will be administered under ultrasound guidance before the induction of general anesthesia. The block will be performed at an appropriate thoracic level using 20 mL of 0.25% bupivacaine as the local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention planned for control group. Patients in the control group will receive a standard analgesia protocol. |
| Block group | Experimental | USG guided single-shot paravertebral block planned for block group Receives: Procedure: paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery -15 (QoR-15) score
The QoR-15 is a clinically acceptable and feasible patient-centred outcome measure after surgery. The score demonstrated good validity, reliability and responsiveness. The score ranges from 0 to 150. O refers to the worst recovery and 150 refers to best recovery.
Measured: Postoperative 24th hours
Secondary outcomes (3)
Visual Analog scale (VAS) score
The Visual Analog Scale (VAS) score is a pain assessment tool. The score ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain ever experienced
Measured: Postoperative 2nd, 4th, 6th, 12th and 24th hours
Opioid consumption
Total opioid consumption in first postoperative day will be recorded
Measured: Postoperative 24th hours
Extubation time
Time frame from the end of the surgery to extubation will be recorded
Measured: Time frame from the end of the surgery to extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start24 Mar 2025 (estimated)
- Primary completion25 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass SurgeryStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882083
- Sponsor's protocol ID
- ADYU-ANS-NY-009
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-Guided Bilateral Single-Shot Paravertebral Block on Recovery After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06882083
- Acronym / sponsor ID
- ADYU-ANS-NY-009
- Keywords
- Paravertebral block, Coronary artery bypass surgery, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 24 Mar 2025 (estimated)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 18 Mar 2025 (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 study aims to evaluate the analgesic efficacy of paravertebral block, mobilization speed, respiratory functions, and complication rates in patients who have undergone cardiac surgery and are monitored in the intensive care unit during the postoperative period.
Detailed description
The aim of this study is to evaluate the effects of a single-dose bilateral paravertebral block administered under ultrasound guidance on the recovery process after cardiac surgery. Effective management of postoperative pain in cardiac surgeries is crucial for enhancing patient comfort, reducing complications, and facilitating rapid recovery. Paravertebral block can be utilized as an effective method for pain management following cardiac surgeries. This technique provides extensive analgesic coverage in the thoracic region while reducing opioid consumption and its associated side effects. Additionally, it supports the preservation of respiratory functions, facilitates early mobilization, and may reduce postoperative complications. When performed under ultrasound guidance, the accuracy and efficacy of the block are enhanced, making it a safe analgesic option in cardiac surgeries. Studies have demonstrated that paravertebral block increases patient satisfaction and contributes positively to the recovery process. Therefore, it is a viable approach for postoperative pain management in cardiac surgery.
This study will be conducted with a prospective, randomized, and controlled design. Patients will be assigned to two groups using a sealed-envelope method: the paravertebral block group and the control group. Patients in the paravertebral block group will receive a single-dose bilateral paravertebral block under ultrasound guidance before the induction of general anesthesia. The block will be performed at an appropriate thoracic level using 20 mL of 0.25% bupivacaine as the local anesthetic. Patients in the control group will receive a standard analgesia protocol.
All patients will be monitored in the intensive care unit during the postoperative period, and the following parameters will be assessed: pain scores using the visual analog scale (VAS), total opioid consumption, extubation times, intensive care unit length of stay, Quality of Recovery-15 (QoR-15) score, and postoperative complications. Data will be collected during the preoperative assessment and throughout the first 48 hours postoperatively.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention planned for control group. Patients in the control group will receive a standard analgesia protocol. |
| Block group | Experimental | Procedure: paravertebral blockUSG guided single-shot paravertebral block planned for block group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 and older scheduled for elective coronary artery bypass graft surgery with median sternotomy
Key exclusion criteria (6 listed)
- Contraindications to neuroaxial block ( coagulopathy, infection at the injection site, allergy to local anesthetics..)
- Emergency surgeries
- severe back deformities
- Chronic pain
- refusal to participate
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 |
|---|---|---|
| paravertebral blockA single-dose bilateral paravertebral block will be administered under ultrasound guidance before the induction of general anesthesia. The block will be performed at an appropriate thoracic level using 20 mL of 0.25% bupivacaine as the local anesthetic. | Procedure or surgery | Block group |
Primary outcome
Quality of Recovery -15 (QoR-15) score
Time frame: Postoperative 24th hours
The QoR-15 is a clinically acceptable and feasible patient-centred outcome measure after surgery. The score demonstrated good validity, reliability and responsiveness. The score ranges from 0 to 150. O refers to the worst recovery and 150 refers to best recovery.
3 secondary outcomes
Visual Analog scale (VAS) score
Time frame: Postoperative 2nd, 4th, 6th, 12th and 24th hours
Opioid consumption
Time frame: Postoperative 24th hours
Extubation time
Time frame: Time frame from the end of the surgery to extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Coronary Artery Bypass Graft (CABG)
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.
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 paravertebral block in people with Coronary Artery Bypass Surgery and Paravertebral Block, run by Adiyaman University Research Hospital.
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 6 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: opening soon, as of the sponsor's last update on 20 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quality of Recovery -15 (QoR-15) score (time frame: Postoperative 24th hours). 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 Mar 2025.