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Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery

Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03128346
Enrollment
100
Registered
2017-04-25
Start date
2017-10-01
Completion date
2018-05-01
Last updated
2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Nerve Block, Cardiac Surgery

Brief 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 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.

Interventions

PROCEDURETransthoracic Transversus Plane Block

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.

IV, Hydromorphone

DRUGAspirin

Oral Aspirin

DRUGAcetaminophen

Oral acetaminophen

DRUGFentanyl

IV, fentanyl

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Participants will be blinded to the randomization

Intervention model description

two groups: the nerve block group and the standard of care group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Narcotic requirements equivalentsFrom the time of ICU admission up to 48 hoursThe amount of narcotics (hydromorphone or fentanyl) required will be assessed on patients' chart.

Secondary

MeasureTime frameDescription
Patient satisfaction satisfactionFrom extubation up to 48 hoursyes or no
Pain score equivalentsFrom the time of ICU admission up to 48 hourson a sclale of 0-10
Respiratory rateAfter extubation up to 48 hoursEvery 2 hours after extubation
Oxygen saturation by pulse oximetryAfter extubation up to 48 hoursAfter extubation
Time to extubationFrom the time of ICU admission up to 24 hours0 hour (the time of ICU admission) to extubation

Other

MeasureTime frameDescription
Nausea/VomitingAfter extubation up to 48 hoursAnti-emetics requirements
AcceptabilityFrom the time of ICU admission up to 48 hoursAcceptability will be assessed using a likert scale questionnaire(Main outcome in the feasibility study, which will be conducted prior to the main study.)
Recruitment rateFrom the time of first recruitment up to one monthRecruitment rate (Main outcome in the feasibility study, which will be conducted prior to the main study.)

Countries

Canada

Contacts

Primary ContactJian Zhou, M.D
ray.zhou@lhsc.on.ca519-685-8500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026