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

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ClinicalTrials.gov Identifier: NCT03128346
Recruitment Status : Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Satoru Fujii, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Nerve Block Cardiac Surgery Procedure: Transthoracic Transversus Plane Block Drug: Hydromorphone Hydrochloride Drug: Aspirin Drug: Acetaminophen Drug: Fentanyl Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two groups: the nerve block group and the standard of care group
Masking: Single (Participant)
Masking Description: Participants will be blinded to the randomization
Primary Purpose: Prevention
Official Title: Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: The nerve block group
TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)
Procedure: Transthoracic 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.

Drug: Hydromorphone Hydrochloride
IV, Hydromorphone

Drug: Aspirin
Oral Aspirin

Drug: Acetaminophen
Oral acetaminophen
Other Name: tylenol

Drug: Fentanyl
IV, fentanyl

Active Comparator: The standard of care group
Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.
Drug: Hydromorphone Hydrochloride
IV, Hydromorphone

Drug: Aspirin
Oral Aspirin

Drug: Acetaminophen
Oral acetaminophen
Other Name: tylenol

Drug: Fentanyl
IV, fentanyl




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to extubation [ Time Frame: From the time of ICU admission up to 24 hours ]
    0 hour (the time of ICU admission) to extubation

  2. Patient satisfaction satisfaction [ Time Frame: From extubation up to 48 hours ]
    yes or no

  3. Pain score equivalents [ Time Frame: From the time of ICU admission up to 48 hours ]
    on a sclale of 0-10

  4. Respiratory rate [ Time Frame: After extubation up to 48 hours ]
    Every 2 hours after extubation

  5. Oxygen saturation by pulse oximetry [ Time Frame: After extubation up to 48 hours ]
    After extubation


Other Outcome Measures:
  1. Recruitment rate [ Time Frame: From the time of first recruitment up to one month ]
    Recruitment rate (Main outcome in the feasibility study, which will be conducted prior to the main study.)

  2. Acceptability [ Time Frame: From the time of ICU admission up to 48 hours ]
    Acceptability will be assessed using a likert scale questionnaire(Main outcome in the feasibility study, which will be conducted prior to the main study.)

  3. Nausea/Vomiting [ Time Frame: After extubation up to 48 hours ]
    Anti-emetics requirements



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128346


Contacts
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Contact: Jian Zhou, M.D 519-685-8500 ext 13302 ray.zhou@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Jian Zhou, MD    519-685-8500 ext 13302    jzhou83@uwo.ca   
Contact: Satoru Fujii, MD    2263782471    satoru.fujii@lhsc.on.ca   
Sponsors and Collaborators
Western University, Canada

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Satoru Fujii, Clinical fellow, Western University, Canada
ClinicalTrials.gov Identifier: NCT03128346     History of Changes
Other Study ID Numbers: 109015
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Aspirin
Acetaminophen
Fentanyl
Analgesics
Hydromorphone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia
Anesthetics, Intravenous