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Clinical Trials/NCT03128346
NCT03128346
Unknown
N/A

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

Western University, Canada1 site in 1 country100 target enrollmentOctober 1, 2017

Overview

Phase
N/A
Intervention
Transthoracic Transversus Plane Block
Conditions
Postoperative Pain
Sponsor
Western University, Canada
Enrollment
100
Locations
1
Primary Endpoint
Narcotic requirements equivalents
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
May 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Western University, Canada
Responsible Party
Principal Investigator
Principal Investigator

Satoru Fujii

Clinical fellow

Western University, Canada

Eligibility 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.

Arms & Interventions

The nerve block group

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

Intervention: Transthoracic Transversus Plane Block

The nerve block group

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

Intervention: Hydromorphone Hydrochloride

The nerve block group

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

Intervention: Aspirin

The nerve block group

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

Intervention: Acetaminophen

The nerve block group

TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)

Intervention: Fentanyl

The standard of care group

Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.

Intervention: Hydromorphone Hydrochloride

The standard of care group

Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.

Intervention: Aspirin

The standard of care group

Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.

Intervention: Acetaminophen

The standard of care group

Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.

Intervention: Fentanyl

Outcomes

Primary Outcomes

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 Outcomes

  • Time to extubation(From the time of ICU admission up to 24 hours)
  • Patient satisfaction satisfaction(From extubation up to 48 hours)
  • Pain score equivalents(From the time of ICU admission up to 48 hours)
  • Respiratory rate(After extubation up to 48 hours)
  • Oxygen saturation by pulse oximetry(After extubation up to 48 hours)

Study Sites (1)

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