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

NCT03128346 | Unknown

• 1 other identifier: 109015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Nerve Block; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Other Outcomes (3)

• Recruitment rate

  From the time of first recruitment up to one month

• Acceptability

  From the time of ICU admission up to 48 hours

• Nausea/Vomiting

  After extubation up to 48 hours

Study Arms (2)

The nerve block group

EXPERIMENTAL

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

Procedure: Transthoracic Transversus Plane Block; Drug: Hydromorphone Hydrochloride; Drug: Aspirin; Drug: Acetaminophen; Drug: Fentanyl

The standard of care group

ACTIVE COMPARATOR

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

Drug: Hydromorphone Hydrochloride; Drug: Aspirin; Drug: Acetaminophen; Drug: Fentanyl

Interventions

Transthoracic Transversus Plane Block PROCEDURE

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.

The nerve block group

Hydromorphone Hydrochloride DRUG

IV, Hydromorphone

The nerve block group; The standard of care group

Aspirin DRUG

Oral Aspirin

The nerve block group; The standard of care group

Acetaminophen DRUG

Oral acetaminophen

Also known as: tylenol

The nerve block group; The standard of care group

Fentanyl DRUG

IV, fentanyl

The nerve block group; The standard of care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (5)

• 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.

  PMID: 26897453 RESULT

• 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.

  PMID: 27547910 RESULT

• 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.

  PMID: 26079353 RESULT

• 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.

  PMID: 27555162 RESULT

• 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.

  PMID: 30902911 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hydromorphone; Aspirin; Acetaminophen; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Jian Zhou, M.D

CONTACT

519-685-8500; ray.zhou@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the randomization
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical fellow

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

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 25, 2017
• Study Start: October 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 5, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)