Postoperative PainNCT04591119
Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery
A study testing Transversus Thoracic Muscle Plane Block and Parasternal Intercostal Plane Block in people with Postoperative Pain and Chest Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Inadequate pain control after coronary artery bypass graft surgery increases mortality and results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied transversus thoracic muscle plane block (TTMPB)… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Postoperative Pain, Chest Pain, Coronary Artery Bypass
- What is being tested?
- Transversus Thoracic Muscle Plane Block and Parasternal Intercostal Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2020to 21 Dec 2020
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status II-III
- Elective coronary artery bypass graft surgery under general anesthesia
Who cannot join
- American Society of Anesthesiologists physical status IV
- Emergency surgery and redo surgery
- Low cardiac output syndrome, perioperative intra-aortic balloon pump support for any reason, bleeding disorder or abnormal coagulation profile, abnormal hepatic and renal parameters, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation on anticoagulation
- Allergy to any study drugs, local infection at the block site
- Opioid abuse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Training nad research Hospital
Muğla
About this study
Official title: Bilateral Transversus Thoracis Muscle Plane Block for Acute Postoperative Pain in Adult Coronary Artery Bypass Graft Surgery: A Randomized Controlled Observer Blinded Trial
Inadequate pain control after coronary artery bypass graft surgery increases mortality and results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied transversus thoracic muscle plane block (TTMPB) would improve the postoperative pain scores and decrease tramadol consumption better after coronary artery bypass graft surgery
- Conditions
- Postoperative Pain, Chest Pain, Coronary Artery Bypass, Sternotomy
- Being tested
- Transversus Thoracic Muscle Plane Block, Parasternal Intercostal Plane Block
- Keywords
- adult cardiac surgery, poststernotomy pain, transversus thoracic muscle plane block, parasternal intercostal block, behavioral pain scale, numeric rating scale
- Medical subject headings
- Pain, Postoperative, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Thoracic Muscle Plane BlockProcedure or surgery
40 ml %0.375 bupivacaine divided into 4 equal doses will be injected by the surgeon between internal intercostal muscle and transversus thoracis muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space
Parasternal Intercostal Plane BlockProcedure or surgery
40 ml %0.375 bupivacaine injection will be performed by ultrasound guidance after completion of surgery between pectoralis major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally by anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Transversus Thoracic Muscle Plane Block (TTMPB) Group | Active comparator | At the TTMPB group, the block will be performed by the surgeon before the closure of the sternum by visualizing the muscles and identifying them. In the TTMPB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between internal intercostal muscle and transversus thoracic muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space. Receives: Procedure: Transversus Thoracic Muscle Plane Block |
| Parasternal Intercostal Block (PSIB) Group | Active comparator | At the PSIB group, the block will be performed by ultrasound guidance after completion of surgery. PSIB Blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesist.In PSIB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally. Receives: Procedure: Parasternal Intercostal Plane Block |
| Control Group | No intervention | At the control group, no intervention for pain management will be done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Tramadol consumption will be assessed by checking patient daily drug order records
Measured: Postoperative 24th hour
Postoperative opioid consumption
Tramadol consumption will be assessed by checking patient daily drug order records
Measured: Postoperative 1st, 4th and 12th hour
Secondary outcomes (2)
Behavioral Pain Scale
A blinded nurse will assess postoperative pain while they are intubated at the 1st and 4th hour by using 3 subscale Behavioral Pain Scale which ranges from 3 (no pain) to 12 (maximum pain)
Measured: postoperative 1st and 4th hour
Numeric Rating Scale
A blinded nurse will assess postoperative pain during resting and movement at postoperative 12th and 24th hour by using Numeric rating scale at the extubated patient by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
Measured: Postoperative 12th and 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Oct 2020
- Primary completion20 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Korkmaz Toker, Muğla Sıtkı Koçman University
- Investigators
- Melike Korkmaz Toker, Assist.Prof, Principal investigator, Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591119
- Sponsor's protocol ID
- MSKU 20-IV
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: via mail
Publications
Ueshima H, Takeda Y, Ishikawa S, Otake H. RETRACTED: Ultrasound-guided transversus thoracic muscle plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2015 Dec;27(8):696. doi: 10.1016/j.jclinane.2015.05.013. Epub 2015 Jul 3. No abstract available.
PubMed 26144912de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
PubMed 24396082
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Transversus Thoracis Muscle Plane Block for Acute Postoperative Pain in Adult Coronary Artery Bypass Graft Surgery: A Randomized Controlled Observer Blinded Trial
- ClinicalTrials.gov ID
- NCT04591119
- Acronym / sponsor ID
- MSKU 20-IV
- Conditions
- Postoperative Pain, Chest Pain, Coronary Artery Bypass, Sternotomy
- Keywords
- adult cardiac surgery, poststernotomy pain, transversus thoracic muscle plane block, parasternal intercostal block, behavioral pain scale, numeric rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 19 Oct 2020 (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.
Inadequate pain control after coronary artery bypass graft surgery increases mortality and results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied transversus thoracic muscle plane block (TTMPB) would improve the postoperative pain scores and decrease tramadol consumption better after coronary artery bypass graft surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transversus Thoracic Muscle Plane Block (TTMPB) Group | Active comparator | Procedure: Transversus Thoracic Muscle Plane BlockAt the TTMPB group, the block will be performed by the surgeon before the closure of the sternum by visualizing the muscles and identifying them. In the TTMPB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between internal intercostal muscle and transversus thoracic muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space. |
| Parasternal Intercostal Block (PSIB) Group | Active comparator | Procedure: Parasternal Intercostal Plane BlockAt the PSIB group, the block will be performed by ultrasound guidance after completion of surgery. PSIB Blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesist.In PSIB group patients will receive 40 ml %0.375 bupivacaine divided into 4 equal doses between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally. |
| Control Group | No intervention | –At the control group, no intervention for pain management will be done. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status II-III
- Elective coronary artery bypass graft surgery under general anesthesia
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists physical status IV
- Emergency surgery and redo surgery
- Low cardiac output syndrome, perioperative intra-aortic balloon pump support for any reason, bleeding disorder or abnormal coagulation profile, abnormal hepatic and renal parameters, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation on anticoagulation
- Allergy to any study drugs, local infection at the block site
- Opioid abuse
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 |
|---|---|---|
| Transversus Thoracic Muscle Plane Block40 ml %0.375 bupivacaine divided into 4 equal doses will be injected by the surgeon between internal intercostal muscle and transversus thoracis muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space | Procedure or surgery | Transversus Thoracic Muscle Plane Block (TTMPB) Group |
| Parasternal Intercostal Plane Block40 ml %0.375 bupivacaine injection will be performed by ultrasound guidance after completion of surgery between pectoralis major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally by anesthesiologist. | Procedure or surgery | Parasternal Intercostal Block (PSIB) Group |
Primary outcome
Postoperative opioid consumption
Time frame: Postoperative 24th hour
Tramadol consumption will be assessed by checking patient daily drug order records
Postoperative opioid consumption
Time frame: Postoperative 1st, 4th and 12th hour
Tramadol consumption will be assessed by checking patient daily drug order records
2 secondary outcomes
Behavioral Pain Scale
Time frame: postoperative 1st and 4th hour
Numeric Rating Scale
Time frame: Postoperative 12th and 24th hour
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 5 Dec 2023.
- Background: PubMed 26144912Ueshima H, Takeda Y, Ishikawa S, Otake H. RETRACTED: Ultrasound-guided transversus thoracic muscle plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2015 Dec;27(8):696. doi: 10.1016/j.jclinane.2015.05.013. Epub 2015 Jul 3. No abstract available.
- Background: PubMed 24396082de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
- Individual participant dataSharing planned: No. via mail
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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.
Melike Korkmaz Toker, Assist.Prof principal investigator
Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Thoracic Muscle Plane Block and Parasternal Intercostal Plane Block in people with Postoperative Pain and Chest Pain, run by Muğla Sıtkı Koçman 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 5 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 5 Dec 2023. 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?
Postoperative opioid consumption (time frame: Postoperative 24th hour). 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?
On the ClinicalTrials.gov record for NCT04591119, which also lists 2 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 5 Dec 2023.