Postoperative PainNCT03128346
Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery
A study testing Transthoracic Transversus Plane Block, Hydromorphone Hydrochloride and Aspirin in people with Postoperative Pain and Nerve Block, run by Western University, Canada at 1 site in Canada.
Trial summary
The TTP block is a novel regional anesthetic technique that shows promise in providing analgesia for anterior chest wall incisions and median sternotomy. The investigators hope to show that by providing the TTP block, there will be reduced early postoperative pain, reduced sedation and shallow breathing, reduced time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Nerve Block, Cardiac Surgery
- What is being tested?
- Transthoracic Transversus Plane Block, Hydromorphone Hydrochloride and Aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2017to 1 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing cardiac surgical procedures performed by a single conventional median sternotomy, and first case of the day patient because early postoperative pain scores are difficult to obtain overnight for patients admitted to the ICU in the evening.
Who cannot join
- patients undergoing non-median sternotomy access, surgeries involving saphenous vein or radial artery harvests, emergency cases, LVEF (Left ventricular efection fraction) <30%, ASAPS (American society of anesthesiologists physical status)=5, known local anesthetic allergy, allergy to any study medications, pre-existing major organ dysfunction including hepatic and renal failure, eGFR (estimated glomerular filtration rate) <60mL/min/1.73m2, coagulopathy, hematological disorders, infection at the site of injection, significant psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression), narcotic dependency (chronic opioid use of greater than 15mg oral morphine equivalents daily), peripheral neuropathy, pregnancy, patient refusal, lack of informed consent, moderate cognitive impairment, and language or reading barrier.
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre
London, Ontario, N6A 5A5
Jian Zhou, MD, 519-685-8500 ext. 13302, jzhou83@uwo.ca
Satoru Fujii, MD, 2263782471, satoru.fujii@lhsc.on.ca
About this study
Official title: Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study
The TTP block is a novel regional anesthetic technique that shows promise in providing analgesia for anterior chest wall incisions and median sternotomy. The investigators hope to show that by providing the TTP block, there will be reduced early postoperative pain, reduced sedation and shallow breathing, reduced time on breathing machine, leading to an increase in patient comfort and satisfaction. The investigators also hope the decreased need for pain medication and reduced time on the breathing machine will translate into decreased nursing workload.
Read the detailed description
In February 2015, Ueshima et al published an article regarding ultrasound guided transversus thoracic muscle plane (TTP) block for breast cancer resection. In this article, he showed that branches of the intercostal nerves (Th2-6) dominate the region of the internal mammary area. By administering local anesthetics between the internal intercostal and transversus thoracic muscle, analgesia in the anterior chest and sternum can be obtained. A cadaveric study shows injectate spread from the second to fifth intercostal spaces with a single 15mL injection between the third and fourth ribs next to the sternum. They further published a case series of two patients who successfully underwent median sternotomy for aortic valve replacement and thymoma resection using only the TTP block for analgesia. Fast- track cardiac surgery is now widely practiced, and evidence for its safety and efficacy has spurred its adoption. With the increased demand for health care resources including nursing manpower and ICU beds, postoperative patients are returning to the cardiac surgery intensive care unit (CSICU) on shorter acting anesthetic agents so that they can be awakened, following commands and spontaneously ventilating earlier. The TTP block fits in well with the fast- track paradigm. By providing adequate analgesia for median sternotomy, the TTP block may reduce narcotic requirements and consequent sedation and respiratory depression, hypercapnia and respiratory acidosis, prolonged mechanical ventilation and need for emergency advanced airway interventions.
- Conditions
- Postoperative Pain, Nerve Block, Cardiac Surgery
- Being tested
- Transthoracic Transversus Plane Block, Hydromorphone Hydrochloride, Aspirin, Acetaminophen, Fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Transversus Plane BlockProcedure or surgery
The investigator (RF or DV) will administer bilateral TTP block under dynamic ultrasound guidance with an echogenic needle using a total of 40mL of 0.5% ropivacaine (200mg), 20mL on each side. If the patient is less than 70kg, the total dose administered will be 40mL of 0.3% ropivacaine (150mg). The patient will not require sedation or analgesia for the performance of the block. The projected time for block completion is 20 minutes after appropriate patient positioning (supine) and exposure (upper chest). After block administration, the patient will be monitored for local anesthetics toxicity, hemodynamic instability, and allergic or unexpected adverse reactions for 20 minutes. Standard intensive care monitors are sufficient.
Hydromorphone HydrochlorideDrug
IV, Hydromorphone
AspirinDrug
Oral Aspirin
AcetaminophenDrug
Also called tylenol
Oral acetaminophen
FentanylDrug
IV, fentanyl
| Study group | Role | What they receive |
|---|---|---|
| The nerve block group | Experimental | TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen) Receives: Procedure: Transthoracic Transversus Plane Block; Drug: Hydromorphone Hydrochloride; Drug: Aspirin; Drug: Acetaminophen; Drug: Fentanyl |
| The standard of care group | Active comparator | Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen. Receives: Drug: Hydromorphone Hydrochloride; Drug: Aspirin; Drug: Acetaminophen; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic requirements equivalents
The amount of narcotics (hydromorphone or fentanyl) required will be assessed on patients' chart.
Measured: From the time of ICU admission up to 48 hours
Secondary outcomes (5)
Time to extubation
0 hour (the time of ICU admission) to extubation
Measured: From the time of ICU admission up to 24 hours
Patient satisfaction satisfaction
yes or no
Measured: From extubation up to 48 hours
Pain score equivalents
on a sclale of 0-10
Measured: From the time of ICU admission up to 48 hours
Respiratory rate
Every 2 hours after extubation
Measured: After extubation up to 48 hours
Oxygen saturation by pulse oximetry
After extubation
Measured: After extubation up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups: the nerve block group and the standard of care group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satoru Fujii, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128346
- Sponsor's protocol ID
- 109015
- Status last verified
- Sep 2017
- First submitted
- 9 Apr 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ueshima H, Hara E, Marui T, Otake H. RETRACTED: The ultrasound-guided transversus thoracic muscle plane block is effective for the median sternotomy. J Clin Anesth. 2016 Mar;29:83. doi: 10.1016/j.jclinane.2015.10.014. Epub 2016 Feb 9. No abstract available.
PubMed 26897453Ueshima H, Otake H. Limitations of the Transversus Thoracic Muscle Plane Block. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):659-60. doi: 10.1097/AAP.0000000000000463. No abstract available.
PubMed 27547910Ueshima H, Kitamura A. Blocking of Multiple Anterior Branches of Intercostal Nerves (Th2-6) Using a Transversus Thoracic Muscle Plane Block. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388. doi: 10.1097/AAP.0000000000000245. No abstract available.
PubMed 26079353Ueshima H, Otake H. Where is an appropriate injection point for an ultrasound-guided transversus thoracic muscle plane block? J Clin Anesth. 2016 Sep;33:190-1. doi: 10.1016/j.jclinane.2016.03.057. Epub 2016 May 1. No abstract available.
PubMed 27555162Fujii S, Roche M, Jones PM, Vissa D, Bainbridge D, Zhou JR. Transversus thoracis muscle plane block in cardiac surgery: a pilot feasibility study. Reg Anesth Pain Med. 2019 May;44(5):556-560. doi: 10.1136/rapm-2018-100178. Epub 2019 Mar 21.
PubMed 30902911
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study
- ClinicalTrials.gov ID
- NCT03128346
- Acronym / sponsor ID
- 109015
- Conditions
- Postoperative Pain, Nerve Block, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 25 Apr 2017 (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 TTP block is a novel regional anesthetic technique that shows promise in providing analgesia for anterior chest wall incisions and median sternotomy. The investigators hope to show that by providing the TTP block, there will be reduced early postoperative pain, reduced sedation and shallow breathing, reduced time on breathing machine, leading to an increase in patient comfort and satisfaction. The investigators also hope the decreased need for pain medication and reduced time on the breathing machine will translate into decreased nursing workload.
Detailed description
In February 2015, Ueshima et al published an article regarding ultrasound guided transversus thoracic muscle plane (TTP) block for breast cancer resection. In this article, he showed that branches of the intercostal nerves (Th2-6) dominate the region of the internal mammary area. By administering local anesthetics between the internal intercostal and transversus thoracic muscle, analgesia in the anterior chest and sternum can be obtained. A cadaveric study shows injectate spread from the second to fifth intercostal spaces with a single 15mL injection between the third and fourth ribs next to the sternum. They further published a case series of two patients who successfully underwent median sternotomy for aortic valve replacement and thymoma resection using only the TTP block for analgesia. Fast- track cardiac surgery is now widely practiced, and evidence for its safety and efficacy has spurred its adoption. With the increased demand for health care resources including nursing manpower and ICU beds, postoperative patients are returning to the cardiac surgery intensive care unit (CSICU) on shorter acting anesthetic agents so that they can be awakened, following commands and spontaneously ventilating earlier. The TTP block fits in well with the fast- track paradigm. By providing adequate analgesia for median sternotomy, the TTP block may reduce narcotic requirements and consequent sedation and respiratory depression, hypercapnia and respiratory acidosis, prolonged mechanical ventilation and need for emergency advanced airway interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups: the nerve block group and the standard of care group
| Arm | Type | Receives |
|---|---|---|
| The nerve block group | Experimental | Procedure: Transthoracic Transversus Plane Block, Drug: Hydromorphone Hydrochloride, Drug: Aspirin, Drug: Acetaminophen, Drug: FentanylTTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen) |
| The standard of care group | Active comparator | Drug: Hydromorphone Hydrochloride, Drug: Aspirin, Drug: Acetaminophen, Drug: FentanylPatients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen. |
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 undergoing cardiac surgical procedures performed by a single conventional median sternotomy, and first case of the day patient because early postoperative pain scores are difficult to obtain overnight for patients admitted to the ICU in the evening.
Key exclusion criteria (1 listed)
- patients undergoing non-median sternotomy access, surgeries involving saphenous vein or radial artery harvests, emergency cases, LVEF (Left ventricular efection fraction) <30%, ASAPS (American society of anesthesiologists physical status)=5, known local anesthetic allergy, allergy to any study medications, pre-existing major organ dysfunction including hepatic and renal failure, eGFR (estimated glomerular filtration rate) <60mL/min/1.73m2, coagulopathy, hematological disorders, infection at the site of injection, significant psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression), narcotic dependency (chronic opioid use of greater than 15mg oral morphine equivalents daily), peripheral neuropathy, pregnancy, patient refusal, lack of informed consent, moderate cognitive impairment, and language or reading barrier.
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 |
|---|---|---|
| Transthoracic Transversus Plane BlockThe investigator (RF or DV) will administer bilateral TTP block under dynamic ultrasound guidance with an echogenic needle using a total of 40mL of 0.5% ropivacaine (200mg), 20mL on each side. If the patient is less than 70kg, the total dose administered will be 40mL of 0.3% ropivacaine (150mg). The patient will not require sedation or analgesia for the performance of the block. The projected time for block completion is 20 minutes after appropriate patient positioning (supine) and exposure (upper chest). After block administration, the patient will be monitored for local anesthetics toxicity, hemodynamic instability, and allergic or unexpected adverse reactions for 20 minutes. Standard intensive care monitors are sufficient. | Procedure or surgery | The nerve block group |
| Hydromorphone HydrochlorideIV, Hydromorphone | Drug | The nerve block group, The standard of care group |
| AspirinOral Aspirin | Drug | The nerve block group, The standard of care group |
| AcetaminophenAlso: tylenolOral acetaminophen | Drug | The nerve block group, The standard of care group |
| FentanylIV, fentanyl | Drug | The nerve block group, The standard of care group |
Primary outcome
Narcotic requirements equivalents
Time frame: From the time of ICU admission up to 48 hours
The amount of narcotics (hydromorphone or fentanyl) required will be assessed on patients' chart.
5 secondary outcomes
Time to extubation
Time frame: From the time of ICU admission up to 24 hours
Patient satisfaction satisfaction
Time frame: From extubation up to 48 hours
Pain score equivalents
Time frame: From the time of ICU admission up to 48 hours
Respiratory rate
Time frame: After extubation up to 48 hours
Oxygen saturation by pulse oximetry
Time frame: After extubation up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Results publication: PubMed 26897453Ueshima H, Hara E, Marui T, Otake H. RETRACTED: The ultrasound-guided transversus thoracic muscle plane block is effective for the median sternotomy. J Clin Anesth. 2016 Mar;29:83. doi: 10.1016/j.jclinane.2015.10.014. Epub 2016 Feb 9. No abstract available.
- Results publication: PubMed 27547910Ueshima H, Otake H. Limitations of the Transversus Thoracic Muscle Plane Block. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):659-60. doi: 10.1097/AAP.0000000000000463. No abstract available.
- Results publication: PubMed 26079353Ueshima H, Kitamura A. Blocking of Multiple Anterior Branches of Intercostal Nerves (Th2-6) Using a Transversus Thoracic Muscle Plane Block. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388. doi: 10.1097/AAP.0000000000000245. No abstract available.
- Results publication: PubMed 27555162Ueshima H, Otake H. Where is an appropriate injection point for an ultrasound-guided transversus thoracic muscle plane block? J Clin Anesth. 2016 Sep;33:190-1. doi: 10.1016/j.jclinane.2016.03.057. Epub 2016 May 1. No abstract available.
- Derived from this study: PubMed 30902911Fujii S, Roche M, Jones PM, Vissa D, Bainbridge D, Zhou JR. Transversus thoracis muscle plane block in cardiac surgery: a pilot feasibility study. Reg Anesth Pain Med. 2019 May;44(5):556-560. doi: 10.1136/rapm-2018-100178. Epub 2019 Mar 21.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic Transversus Plane Block, Hydromorphone Hydrochloride and Aspirin in people with Postoperative Pain and Nerve Block, run by Western University, Canada at 1 site in Canada.
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 1 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 5 Sep 2017. 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 Canada. 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 Jian Zhou, M.D (519-685-8500 ext. 13302, ray.zhou@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic requirements equivalents (time frame: From the time of ICU admission up to 48 hours). 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 NCT03128346, which also lists 5 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 Sep 2017.