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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

Tracking Information
First Submitted Date  ICMJE April 9, 2017
First Posted Date  ICMJE April 25, 2017
Last Update Posted Date September 5, 2017
Estimated Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
Pain score [ Time Frame: From the time of ICU admission up to 48 hours ]
on a scale of 0-10
Change History Complete list of historical versions of study NCT03128346 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
  • Time to extubation [ Time Frame: From the time of ICU admission up to 24 hours ]
    0 hour (the time of ICU admission) to extubation
  • Patient satisfaction satisfaction [ Time Frame: From extubation up to 48 hours ]
    yes or no
  • Pain score equivalents [ Time Frame: From the time of ICU admission up to 48 hours ]
    on a sclale of 0-10
  • Respiratory rate [ Time Frame: After extubation up to 48 hours ]
    Every 2 hours after extubation
  • Oxygen saturation by pulse oximetry [ Time Frame: After extubation up to 48 hours ]
    After extubation
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Time to extubation [ Time Frame: From the time of ICU admission up to 24 hours ]
    0 hour (the time of ICU admission) to extubation
  • Patient satisfaction satisfaction [ Time Frame: From extubation up to 48 hours ]
    yes or no
  • 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.
  • Respiratory rate [ Time Frame: After extubation up to 48 hours ]
    Every 2 hours after extubation
  • Oxygen saturation by pulse oximetry [ Time Frame: After extubation up to 48 hours ]
    After extubation
Current Other Pre-specified Outcome Measures
 (submitted: September 1, 2017)
  • 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.)
  • 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.)
  • Nausea/Vomiting [ Time Frame: After extubation up to 48 hours ]
    Anti-emetics requirements
Original Other Pre-specified Outcome Measures
 (submitted: April 24, 2017)
  • Recruitment rate [ Time Frame: From the time of first recruitment up to one month ]
    Recruitment rate (How many patients participated in this study in a month)
  • Acceptability [ Time Frame: From the time of ICU admission up to 48 hours ]
    Acceptability will be assessed using a likert scale questionnaire
  • Nausea/Vomiting [ Time Frame: After extubation up to 48 hours ]
    Yes or no
 
Descriptive Information
Brief Title  ICMJE Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery
Official Title  ICMJE Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Postoperative Pain
  • Nerve Block
  • Cardiac Surgery
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: The nerve block group
    TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)
    Interventions:
    • Procedure: Transthoracic Transversus Plane Block
    • Drug: Hydromorphone Hydrochloride
    • Drug: Aspirin
    • Drug: Acetaminophen
    • Drug: 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.
    Interventions:
    • Drug: Hydromorphone Hydrochloride
    • Drug: Aspirin
    • Drug: Acetaminophen
    • Drug: Fentanyl
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2018
Estimated Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jian Zhou, M.D 519-685-8500 ext 13302 ray.zhou@lhsc.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128346
Other Study ID Numbers  ICMJE 109015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Satoru Fujii, Western University, Canada
Study Sponsor  ICMJE Western University, Canada
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Western University, Canada
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP