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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Cardiac Surgery; Nerve Block
• Intervention / Treatment: Procedure: Transthoracic Transversus Plane Block; Drug: Hydromorphone Hydrochloride; Drug: Aspirin; Drug: Acetaminophen; Drug: Fentanyl

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Zhou, M.D; Phone Number: 13302 519-685-8500; Email: ray.zhou@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
      • Contact: Jian Zhou, MD; Phone Number: 13302 519-685-8500; Email: jzhou83@uwo.ca
      • Contact: Satoru Fujii, MD; Phone Number: 2263782471; Email: satoru.fujii@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: tylenol; Drug: Fentanyl; IV, fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic requirements equivalents	The amount of narcotics (hydromorphone or fentanyl) required will be assessed on patients' chart.	From the time of ICU admission up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to extubation	0 hour (the time of ICU admission) to extubation	From the time of ICU admission up to 24 hours
Patient satisfaction satisfaction	yes or no	From extubation up to 48 hours
Pain score equivalents	on a sclale of 0-10	From the time of ICU admission up to 48 hours
Respiratory rate	Every 2 hours after extubation	After extubation up to 48 hours
Oxygen saturation by pulse oximetry	After extubation	After extubation up to 48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Recruitment rate (Main outcome in the feasibility study, which will be conducted prior to the main study.)	From the time of first recruitment up to one month
Acceptability	Acceptability will be assessed using a likert scale questionnaire(Main outcome in the feasibility study, which will be conducted prior to the main study.)	From the time of ICU admission up to 48 hours
Nausea/Vomiting	Anti-emetics requirements	After extubation up to 48 hours

Collaborators and Investigators

• Sponsor: Western University, Canada

Publications and helpful links

General 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.
• Ueshima 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.
• Ueshima 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.
• Ueshima 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.
• Fujii 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2017
• Primary Completion (ANTICIPATED): May 1, 2018
• Study Completion (ANTICIPATED): May 1, 2018

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (ACTUAL): April 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Aspirin; Fentanyl; Acetaminophen; Hydromorphone
• Other Study ID Numbers: 109015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No