Post Operative PainNCT06553573
Comparison of PSB and RIFPB Combination With PSB and ESPB Combination in Cardiac Surgery With Sternotomy
A study testing Parasternal Block and Recto-İntercostal Fascial Plane Block and Parasternal Block and Erector Spinae Plane Block in people with Post Operative Pain, run by Cumhuriyet University.
Trial summary
The goal of this study is to compare the analgesic efficacy of the combination of PSB and RIFPB and the combination of PSB and ESPB in patients undergoing cardiac surgery with sternotomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Parasternal Block and Recto-İntercostal Fascial Plane Block and Parasternal Block and Erector Spinae Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 20 Sep 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 18 years of age who will undergo cardiac surgery with sternotomy under general anesthesia and who are in classes I-IIIII according to the American Society of Anesthesiologists (ASA) risk classification.
Who cannot join
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Analgesic Efficacy Comparison of a Combination of Superficial Parasternal Block (PSB) and Recto-intercostal Fascial Plane Block (RİFPB) Versus a Combination of Erector Spinae Plane Block (ESPB) and Superficial Parasternal Block (PSB) in Patients Undergoing Cardiac Surgery With Sternotomy.
The goal of this study is to compare the analgesic efficacy of the combination of PSB and RIFPB and the combination of PSB and ESPB in patients undergoing cardiac surgery with sternotomy.
Read the detailed description
This study will consist of two randomized groups: Group RIFPB (n=12), Group ESP (n=12). All patients will receive standard general anesthesia. Group RIFPB patients will receive PSB and RIFPB with 0.25% bupivacaine (total volume 60 ml) bilaterally. Group ESPB patients will receive PSB and ESPB with 0.25% bupivacaine (total volume 60 ml) bilaterally. All blocks will be performed after induction of general anesthesia and before surgical incision. All patients in the study will be given 50 mg dexketoprofen and 1 g paracetamol intravenously (i.v.) 10 minutes before skin closure. Within the first 24 hours after surgery, all patients will be given 3x1 g iv paracetamol and 2x50 mg dexketoprofen. Numerical Rating Scale (NRS) will be used to assess postoperative pain at 1, 6, 12, 18 and 24 hours. All patients will receive morphine via a patient-controlled analgesia (PCA) device within 24 hours of surgery. If pain score is ≥ 4 despite this protocol, 50 mg tramadol iv (maximum dose 300 mg/day) will be administered as rescue analgesia.
- Conditions
- Post Operative Pain
- Being tested
- Parasternal Block and Recto-İntercostal Fascial Plane Block, Parasternal Block and Erector Spinae Plane Block
- Keywords
- sternotomy, cardiac surgery, parasternal block, recto-intercostal fascial plane block, erector spinae plane block, regional anesthesia, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal Block and Recto-İntercostal Fascial Plane BlockOther
Parasternal Block and Recto-Intercostal Fascial Plane Block:Superficial PSB is performed bilaterally with the patient in the supine position using a high-frequency linear USG probe. The probe is inserted longitudinally 2cm lateral to the sternal border to visualize the T2T4 intercostal space and identify the pectoralis major muscle, intercostal muscle, and pleura. Using an in-plane approach with a 100mm needle, 10ml of 0.25% bupivacaine is administered between the pectoralis major and intercostal muscle. Additionally, a Recto-Intercostal Fascial Plane Block is performed bilaterally with a high-frequency linear USG probe. The probe is inserted 2-3cm lateral to the xiphoid to visualize the rectus abdominis muscle and the 6th-7th cartilages. The needle is advanced to the plane between the costal cartilage and the rectus abdominis muscle using the in-plane technique, and 1-2ml of saline is injected. After spreading to the target plane is observed, 20ml of 0.25% bupivacaine is administered.
Parasternal Block and Erector Spinae Plane BlockOther
Superficial PSB is performed with the patient in the supine position using a high-frequency linear USG probe. The probe is placed longitudinally 2cm lateral to the sternal border to identify the T2T4 intercostal space, pectoralis major muscle, intercostal muscle, and pleura. Using an in-plane approach with a 100mm needle, 10ml of 0.25% bupivacaine is applied between the pectoralis major and intercostal muscle. Additionally, an erector spinae plane block is performed with a high-frequency USG probe. Erector spinae plane block is performed under general anesthesia, in the lateral position, under USG guidance, after sterilization, by inserting a needle between the deep surface of the erector spinae muscle and the transverse process with an in-plane approach in the craniocaudal direction. If no air or blood is seen in the aspiration, a 2mL serum test dose is applied to this area and a total of 20mL of 0.25% bupivacaine is injected bilaterally to perform an erector spinae plane block.
| Study group | Role | What they receive |
|---|---|---|
| Parasternal Block and Recto-İntercostal Fascial Plane Block | Active comparator | Before surgery, patients will receive a combination of bilateral PSB and RIFPB with 0.25% bupivacaine (total volume 60 ml) for postoperative pain control. Receives: Other: Parasternal Block and Recto-İntercostal Fascial Plane Block |
| Parasternal Block and Erector Spinae Plane Block | Active comparator | Before surgery, patients will be given 0.25% bupivacaine (total volume 60 ml) with a combination of bilateral PSB and ESPB for postoperative pain control. Receives: Other: Parasternal Block and Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the numerical rating scale scores
Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Measured: Postoperative 24 hours
Secondary outcomes (1)
Comparing total morphine consumption
Postoperative analgesic need
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- Oğuz Gündoğdu, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553573
- Sponsor's protocol ID
- PSB and RİFPB vs PSB and ESPB
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy Comparison of a Combination of Superficial Parasternal Block (PSB) and Recto-intercostal Fascial Plane Block (RİFPB) Versus a Combination of Erector Spinae Plane Block (ESPB) and Superficial Parasternal Block (PSB) in Patients Undergoing Cardiac Surgery With Sternotomy.
- ClinicalTrials.gov ID
- NCT06553573
- Acronym / sponsor ID
- PSB and RİFPB vs PSB and ESPB
- Conditions
- Post Operative Pain
- Keywords
- sternotomy, cardiac surgery, parasternal block, recto-intercostal fascial plane block, erector spinae plane block, regional anesthesia, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 14 Aug 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 goal of this study is to compare the analgesic efficacy of the combination of PSB and RIFPB and the combination of PSB and ESPB in patients undergoing cardiac surgery with sternotomy.
Detailed description
This study will consist of two randomized groups: Group RIFPB (n=12), Group ESP (n=12). All patients will receive standard general anesthesia. Group RIFPB patients will receive PSB and RIFPB with 0.25% bupivacaine (total volume 60 ml) bilaterally. Group ESPB patients will receive PSB and ESPB with 0.25% bupivacaine (total volume 60 ml) bilaterally. All blocks will be performed after induction of general anesthesia and before surgical incision. All patients in the study will be given 50 mg dexketoprofen and 1 g paracetamol intravenously (i.v.) 10 minutes before skin closure. Within the first 24 hours after surgery, all patients will be given 3x1 g iv paracetamol and 2x50 mg dexketoprofen. Numerical Rating Scale (NRS) will be used to assess postoperative pain at 1, 6, 12, 18 and 24 hours. All patients will receive morphine via a patient-controlled analgesia (PCA) device within 24 hours of surgery. If pain score is ≥ 4 despite this protocol, 50 mg tramadol iv (maximum dose 300 mg/day) will be administered as rescue analgesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parasternal Block and Recto-İntercostal Fascial Plane Block | Active comparator | Other: Parasternal Block and Recto-İntercostal Fascial Plane BlockBefore surgery, patients will receive a combination of bilateral PSB and RIFPB with 0.25% bupivacaine (total volume 60 ml) for postoperative pain control. |
| Parasternal Block and Erector Spinae Plane Block | Active comparator | Other: Parasternal Block and Erector Spinae Plane BlockBefore surgery, patients will be given 0.25% bupivacaine (total volume 60 ml) with a combination of bilateral PSB and ESPB for postoperative pain control. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients over 18 years of age who will undergo cardiac surgery with sternotomy under general anesthesia and who are in classes I-IIIII according to the American Society of Anesthesiologists (ASA) risk classification.
Key exclusion criteria (7 listed)
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
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 |
|---|---|---|
| Parasternal Block and Recto-İntercostal Fascial Plane BlockParasternal Block and Recto-Intercostal Fascial Plane Block:Superficial PSB is performed bilaterally with the patient in the supine position using a high-frequency linear USG probe. The probe is inserted longitudinally 2cm lateral to the sternal border to visualize the T2T4 intercostal space and identify the pectoralis major muscle, intercostal muscle, and pleura. Using an in-plane approach with a 100mm needle, 10ml of 0.25% bupivacaine is administered between the pectoralis major and intercostal muscle. Additionally, a Recto-Intercostal Fascial Plane Block is performed bilaterally with a high-frequency linear USG probe. The probe is inserted 2-3cm lateral to the xiphoid to visualize the rectus abdominis muscle and the 6th-7th cartilages. The needle is advanced to the plane between the costal cartilage and the rectus abdominis muscle using the in-plane technique, and 1-2ml of saline is injected. After spreading to the target plane is observed, 20ml of 0.25% bupivacaine is administered. | Other | Parasternal Block and Recto-İntercostal Fascial Plane Block |
| Parasternal Block and Erector Spinae Plane BlockSuperficial PSB is performed with the patient in the supine position using a high-frequency linear USG probe. The probe is placed longitudinally 2cm lateral to the sternal border to identify the T2T4 intercostal space, pectoralis major muscle, intercostal muscle, and pleura. Using an in-plane approach with a 100mm needle, 10ml of 0.25% bupivacaine is applied between the pectoralis major and intercostal muscle. Additionally, an erector spinae plane block is performed with a high-frequency USG probe. Erector spinae plane block is performed under general anesthesia, in the lateral position, under USG guidance, after sterilization, by inserting a needle between the deep surface of the erector spinae muscle and the transverse process with an in-plane approach in the craniocaudal direction. If no air or blood is seen in the aspiration, a 2mL serum test dose is applied to this area and a total of 20mL of 0.25% bupivacaine is injected bilaterally to perform an erector spinae plane block. | Other | Parasternal Block and Erector Spinae Plane Block |
Primary outcome
Comparing the numerical rating scale scores
Time frame: Postoperative 24 hours
Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
1 secondary outcome
Comparing total morphine consumption
Time frame: Postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
Oğuz Gündoğdu principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
A study testing Parasternal Block and Recto-İntercostal Fascial Plane Block and Parasternal Block and Erector Spinae Plane Block in people with Post Operative Pain, run by Cumhuriyet 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 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: status not confirmed, as of the sponsor's last update on 14 Aug 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?
Contact Oğuz Gündoğdu (+905545945469, droguzgundogdu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the numerical rating scale scores (time frame: Postoperative 24 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 14 Aug 2024.