Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery
Primary Purpose
Postoperative Pain, Nerve Block, Cardiac Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transthoracic Transversus Plane Block
Hydromorphone Hydrochloride
Aspirin
Acetaminophen
Fentanyl
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
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.
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The nerve block group
The standard of care group
Arm Description
TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)
Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.
Outcomes
Primary Outcome Measures
Narcotic requirements equivalents
The amount of narcotics (hydromorphone or fentanyl) required will be assessed on patients' chart.
Secondary Outcome Measures
Time to extubation
0 hour (the time of ICU admission) to extubation
Patient satisfaction satisfaction
yes or no
Pain score equivalents
on a sclale of 0-10
Respiratory rate
Every 2 hours after extubation
Oxygen saturation by pulse oximetry
After extubation
Full Information
NCT ID
NCT03128346
First Posted
April 9, 2017
Last Updated
September 1, 2017
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT03128346
Brief Title
Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery
Official Title
Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
May 1, 2018 (Anticipated)
Study Completion Date
May 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Nerve Block, Cardiac Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups: the nerve block group and the standard of care group
Masking
Participant
Masking Description
Participants will be blinded to the randomization
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The nerve block group
Arm Type
Experimental
Arm Description
TTP block under dynamic ultrasound guidance plus the standard care (hydromorphone, fentanyl, aspirin, acetaminophen)
Arm Title
The standard of care group
Arm Type
Active Comparator
Arm Description
Patients in the standard care group will receive pain medications, such as hydromorphone, fentanyl, aspirin and acetaminophen.
Intervention Type
Procedure
Intervention Name(s)
Transthoracic Transversus Plane Block
Intervention Description
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
Drug
Intervention Name(s)
Hydromorphone Hydrochloride
Intervention Description
IV, Hydromorphone
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Oral Aspirin
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
tylenol
Intervention Description
Oral acetaminophen
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
IV, fentanyl
Primary Outcome Measure Information:
Title
Narcotic requirements equivalents
Description
The amount of narcotics (hydromorphone or fentanyl) required will be assessed on patients' chart.
Time Frame
From the time of ICU admission up to 48 hours
Secondary Outcome Measure Information:
Title
Time to extubation
Description
0 hour (the time of ICU admission) to extubation
Time Frame
From the time of ICU admission up to 24 hours
Title
Patient satisfaction satisfaction
Description
yes or no
Time Frame
From extubation up to 48 hours
Title
Pain score equivalents
Description
on a sclale of 0-10
Time Frame
From the time of ICU admission up to 48 hours
Title
Respiratory rate
Description
Every 2 hours after extubation
Time Frame
After extubation up to 48 hours
Title
Oxygen saturation by pulse oximetry
Description
After extubation
Time Frame
After extubation up to 48 hours
Other Pre-specified Outcome Measures:
Title
Recruitment rate
Description
Recruitment rate (Main outcome in the feasibility study, which will be conducted prior to the main study.)
Time Frame
From the time of first recruitment up to one month
Title
Acceptability
Description
Acceptability will be assessed using a likert scale questionnaire(Main outcome in the feasibility study, which will be conducted prior to the main study.)
Time Frame
From the time of ICU admission up to 48 hours
Title
Nausea/Vomiting
Description
Anti-emetics requirements
Time Frame
After extubation up to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhou, M.D
Phone
519-685-8500
Ext
13302
Email
ray.zhou@lhsc.on.ca
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhou, MD
Phone
519-685-8500
Ext
13302
Email
jzhou83@uwo.ca
First Name & Middle Initial & Last Name & Degree
Satoru Fujii, MD
Phone
2263782471
Email
satoru.fujii@lhsc.on.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26897453
Citation
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.
Results Reference
result
PubMed Identifier
27547910
Citation
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.
Results Reference
result
PubMed Identifier
26079353
Citation
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.
Results Reference
result
PubMed Identifier
27555162
Citation
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.
Results Reference
result
PubMed Identifier
30902911
Citation
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.
Results Reference
derived
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Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery
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