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

NCT ID: NCT03128346

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-05-01

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.

Conditions

Postoperative Pain; Nerve Block; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

The nerve block group

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

Group Type: EXPERIMENTAL

Transthoracic Transversus Plane Block

Intervention Type: 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.

Hydromorphone Hydrochloride

Intervention Type: DRUG

IV, Hydromorphone

Aspirin

Intervention Type: DRUG

Oral Aspirin

Acetaminophen

Intervention Type: DRUG

Oral acetaminophen

Fentanyl

Intervention Type: DRUG

IV, fentanyl

The standard of care group

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

Group Type: ACTIVE_COMPARATOR

Hydromorphone Hydrochloride

Intervention Type: DRUG

IV, Hydromorphone

Aspirin

Intervention Type: DRUG

Oral Aspirin

Acetaminophen

Intervention Type: DRUG

Oral acetaminophen

Fentanyl

Intervention Type: DRUG

IV, fentanyl

Interventions

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.

Intervention Type: PROCEDURE

Hydromorphone Hydrochloride

IV, Hydromorphone

Intervention Type: DRUG

Aspirin

Oral Aspirin

Intervention Type: DRUG

Acetaminophen

Oral acetaminophen

Intervention Type: DRUG

Fentanyl

IV, fentanyl

Intervention Type: DRUG

Other Intervention Names

tylenol

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Satoru Fujii

Clinical fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Central Contacts

Jian Zhou, M.D

Role: CONTACT

ray.zhou@lhsc.on.ca

519-685-8500 ext. 13302

Facility Contacts

Jian Zhou, MD

Role: primary

jzhou83@uwo.ca

519-685-8500 ext. 13302

Satoru Fujii, MD

Role: backup

satoru.fujii@lhsc.on.ca

2263782471

References

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.

Reference Type: RESULT

PMID: 26897453 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27547910 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26079353 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27555162 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30902911 (View on PubMed)

Other Identifiers

109015

Identifier Type: -

Identifier Source: org_study_id