Pain, PostoperativeNCT04791592
Pecto-Intercostal Fascial Block vs. Transversus Thoracic Muscle Plane Block in Cardiac Surgery
A study testing Single-injection, ultrasound-guided bilateral PIF block. and Single-injection, ultrasound-guided bilateral TTMP block. in people with Pain, Postoperative and Coronary Artery Disease, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Coronary Artery Disease
- What is being tested?
- Single-injection, ultrasound-guided bilateral PIF block. and Single-injection, ultrasound-guided bilateral TTMP block.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2021to 22 Apr 2021
- 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
- ASA 1-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery with median sternotomy +/- valve replacement or isolated valve surgery)
- BMI <35 kg / m2
Who cannot join
- Emergent surgeries, redo cases, minimally invasive procedures
- Patients who do not want to participate
- Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
- Hypersensitivity or history of allergies to local anesthetics
- Patients with severe major organ dysfunction (such as renal or hepatic insufficiency)
- LVEF <30
Show all 11Show fewer
- Patients with psychiatric disorders
- Pregnancy or breastfeeding
- Presence of hematological disease
- Patients with alcohol-drug addiction
- Patients who use daily opioids for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block for Acute Post-sternotomy Pain After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study
In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intraoperative and 24 h postoperative opioid consumption.
Read the detailed description
It has been reported that the TTMP block and PIF block produce effective postoperative analgesia for open cardiac surgeries.
The hypothesis of our study; PIF block reduces pain and analgesic consumption in the acute period (0-24 hours) similar to TTP block in patients undergoing elective cardiac surgery requiring median sternotomy.
Patients will be divided into two groups:
Group PIFB: A bilateral PIF block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.
Group TTMPB: A bilateral TTMP block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
- Conditions
- Pain, Postoperative, Coronary Artery Disease
- Being tested
- Single-injection, ultrasound-guided bilateral PIF block., Single-injection, ultrasound-guided bilateral TTMP block.
- Keywords
- Pain, Postoperative, Surgery, Cardiac, Nerve, Block
- Medical subject headings
- Pain, Postoperative, Coronary Artery Disease, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-injection, ultrasound-guided bilateral PIF block.Procedure or surgery
PIF block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients.
Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV.
Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose).
In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day).
For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.
Single-injection, ultrasound-guided bilateral TTMP block.Procedure or surgery
TTMP block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients.
Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV.
Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose).
In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day).
For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Group PIFB | Active comparator | PIF block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA Receives: Procedure: Single-injection, ultrasound-guided bilateral PIF block. |
| Group TTMPB | Active comparator | TTMP block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA Receives: Procedure: Single-injection, ultrasound-guided bilateral TTMP block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in the first 24 hours after surgery
Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.
Measured: Postoperative day 1
Secondary outcomes (8)
Postoperative pain: NRS score
Pain status at rest and while coughing will be assessed by NRS scores at 0, 3, 6, 12, 18, and 24 hours after extubation.In addition, the time until first analgesic requirement will be recorded. The NRS is an 11-point numeric scale which ranges from 0 to 10.
Measured: Postoperative Day 1
Postoperative nausea and vomiting (PONV)
The patients will be verbally evaluated according to a descriptive five-point PONV scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Measured: Postoperative Day 1
Patient satisfaction
Patients' satisfaction with pain management will be evaluated with a 5-point verbal satisfaction scale at the end of 24 hours. The Likert scale is 5 = very satisfied, 4 = satisfied, 3 = unsure, 2 = dissatisfied, 1 = very dissatisfied.
Measured: Postoperative Day 1
The number of patient required rescue analgesic
The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.
Measured: Postoperative Day 1
Time to extubation
After the operation, the time until the patient is extubated will be recorded.
Measured: Postoperative Day 1
Length of stay in the ICU
Total duration of stay in ICU will be recorded.
Measured: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days
Length of stay in the hospital
Their stay in the hospital will be recorded.
Measured: Measured in days admitted in the hospital, an average of 7 days
The number of patients with complications
The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded.
Measured: Postoperative 7 days on an average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start12 Mar 2021
- Primary completion14 Apr 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly classified into two groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz KAYA, Ondokuz Mayıs University
- Investigators
- Deniz Karakaya, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791592
- Sponsor's protocol ID
- PIFB-TTPB19
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.
PubMed 32798172Kelava 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 32032103Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.
PubMed 31356362Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818.
PubMed 31833864Markham T, Wegner R, Hernandez N, Lee JW, Choi W, Eltzschig HK, Zaki J. Assessment of a multimodal analgesia protocol to allow the implementation of enhanced recovery after cardiac surgery: Retrospective analysis of patient outcomes. J Clin Anesth. 2019 May;54:76-80. doi: 10.1016/j.jclinane.2018.10.035. Epub 2018 Nov 6.
PubMed 30412813Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
PubMed 32665179
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pecto-Intercostal Fascial Block Versus Transversus Thoracic Muscle Plane Block for Acute Post-sternotomy Pain After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT04791592
- Acronym / sponsor ID
- PIFB-TTPB19
- Conditions
- Pain, Postoperative, Coronary Artery Disease
- Keywords
- Pain, Postoperative, Surgery, Cardiac, Nerve, Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 10 Mar 2021 (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.
In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intraoperative and 24 h postoperative opioid consumption.
Detailed description
It has been reported that the TTMP block and PIF block produce effective postoperative analgesia for open cardiac surgeries.
The hypothesis of our study; PIF block reduces pain and analgesic consumption in the acute period (0-24 hours) similar to TTP block in patients undergoing elective cardiac surgery requiring median sternotomy.
Patients will be divided into two groups:
Group PIFB: A bilateral PIF block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.
Group TTMPB: A bilateral TTMP block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The patients will be randomly classified into two groups.
| Arm | Type | Receives |
|---|---|---|
| Group PIFB | Active comparator | Procedure: Single-injection, ultrasound-guided bilateral PIF block.PIF block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA |
| Group TTMPB | Active comparator | Procedure: Single-injection, ultrasound-guided bilateral TTMP block.TTMP block (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline) + IV morphine-PCA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery with median sternotomy +/- valve replacement or isolated valve surgery)
- BMI <35 kg / m2
Key exclusion criteria (11 listed)
- Emergent surgeries, redo cases, minimally invasive procedures
- Patients who do not want to participate
- Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
- Hypersensitivity or history of allergies to local anesthetics
- Patients with severe major organ dysfunction (such as renal or hepatic insufficiency)
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 |
|---|---|---|
| Single-injection, ultrasound-guided bilateral PIF block.PIF block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients. Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit. | Procedure or surgery | Group PIFB |
| Single-injection, ultrasound-guided bilateral TTMP block.TTMP block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients. Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit. | Procedure or surgery | Group TTMPB |
Primary outcome
Morphine consumption in the first 24 hours after surgery
Time frame: Postoperative day 1
Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.
8 secondary outcomes
Postoperative pain: NRS score
Time frame: Postoperative Day 1
Postoperative nausea and vomiting (PONV)
Time frame: Postoperative Day 1
Patient satisfaction
Time frame: Postoperative Day 1
The number of patient required rescue analgesic
Time frame: Postoperative Day 1
Time to extubation
Time frame: Postoperative Day 1
Length of stay in the ICU
Time frame: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days
Length of stay in the hospital
Time frame: Measured in days admitted in the hospital, an average of 7 days
The number of patients with complications
Time frame: Postoperative 7 days on an average
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 23 Apr 2021.
- Background: PubMed 32798172Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.
- Background: 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.
- Background: PubMed 31356362Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.
- Background: PubMed 31833864Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818.
- Background: PubMed 30412813Markham T, Wegner R, Hernandez N, Lee JW, Choi W, Eltzschig HK, Zaki J. Assessment of a multimodal analgesia protocol to allow the implementation of enhanced recovery after cardiac surgery: Retrospective analysis of patient outcomes. J Clin Anesth. 2019 May;54:76-80. doi: 10.1016/j.jclinane.2018.10.035. Epub 2018 Nov 6.
- Results publication: PubMed 32665179Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
- 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.
Deniz Karakaya study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-injection, ultrasound-guided bilateral PIF block. and Single-injection, ultrasound-guided bilateral TTMP block. in people with Pain, Postoperative and Coronary Artery Disease, run by Ondokuz Mayıs University 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 2 inclusion and 11 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 23 Apr 2021. 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?
Morphine consumption in the first 24 hours after surgery (time frame: Postoperative day 1). 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 NCT04791592, which also lists 6 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 23 Apr 2021.