search
Back to results

Postoperative Pain Relief With Transversus Thoracis Muscle Plane Block After Cardiac Surgery (TTPcat)

Primary Purpose

Pain, Postoperative, Anesthesia, Local, Coronary Artery Disease

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Placebo
Ropivacaine
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Transversus thoracis muscle pain block, ropivacain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 - 80 years of age
  2. The patient is scheduled for open cardiac coronary arterial bypass graft (CABG) OR single heart valve surgery that require median sternotomy under general anesthesia
  3. Patients that are estimated to be weaned from mechanical ventilator not later than 8 h after surgery
  4. Patients that are capable of using the patient controlled analgesia device (PCA) after surgery
  5. Written informed consent from the patient

Exclusion Criteria:

  1. A previous history of intolerance to the study drug or related compounds and additives
  2. Redo surgery
  3. Combined CABG and heart valve surgery
  4. Endocarditis and/or mediastinitis.
  5. Concomitant drug therapy with strong opioids or strong CYP3A4 or CYP2D6 inductor(s) or inhibitor(s) 2 weeks prior to study.
  6. Patients younger than 18 years or older than 80 years.
  7. Body weight < 60 kg
  8. BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
  9. Diagnosed hepatic cirrhosis or kidney disease: GFR < 29 ml/min/1,73 m2 or dependence on dialysis
  10. History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent. If the researcher judge, that the patient has a mental health disorder, retardation or other similar reason and do not have the capacity to give his/her consent to research or patient do not understand the meaning of the study, or is not able to use PCA device, the patient is to be exluded. History of alcoholism or drug abuse (especially opioid) may affect the use of opioid PCA device and make harm to the patient or invalid the study and are exluded.
  11. Cardiac insufficiency, ejection fraction (LVEF) < 30 %
  12. Patients with a diagnosis for neuropathic pain or chronic pain syndrome
  13. Insulin dependent diabetes mellitus with neuropathy
  14. Participation in any other study concomitantly or within one month prior to the entry into this study
  15. Donation of blood for 4 weeks prior and during the study
  16. Pregnancy or breastfeeding

Sites / Locations

  • Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of TurkuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

G1, Placebo

G2, Ropivacaine

Arm Description

Intravenous saline (NaCl 0,9%) will be administered. G1 group will be administered an initial dose of placebo (20ml) per catheter bilaterally (total volume 40ml) after TTP has been placed. This is followed by 20ml doses of placebo per catheter every 8 hours until 72 hours from the first dose has passed.

Ropivacaine 0.5%. G2 group will be administered an initial dose of ropivacaine (20 ml) per catheter bilaterally (total volume 40ml) after the TTP has been placed. This is followed by 20 ml doses of ropivacain per catheter every 8 hours until 72 hours from the first dose has passed.

Outcomes

Primary Outcome Measures

Number of patients with satisfactory pain response measured with visual rating scale (VAS)
Number of patients with visual rating scale (VAS, 0-100 mm, min 0 mm, max 100 mm, higher score means worse outcome) value under 30 mm

Secondary Outcome Measures

Change in opioid consumption (mg) postoperatively
Change from baseline opioid consumption (mg) postoperatively at 24 hours
Patient reported sensation that is considered to be caused by systemic toxicity of ropivacaine.
Symptoms of local anesthetic systemic toxicity (LAST) (yes/no, + mild, ++ moderate, +++ severe) including metallic taste, ringing in the ears, tremors, tongue paraesthesia, dizziness, slurred speech, muscle twitching and/or convulsions
Change in the length of stay in the hospital
Change from baseline lenght (hours) of stay in the hospital

Full Information

First Posted
May 27, 2021
Last Updated
March 15, 2023
Sponsor
Turku University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04916418
Brief Title
Postoperative Pain Relief With Transversus Thoracis Muscle Plane Block After Cardiac Surgery
Acronym
TTPcat
Official Title
Ultrasound Guided Repeated Bilateral Transversus Thoracis Muscle Plane Block Via Catheter and Postoperative Pain in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital

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
This study aims to investigate the effect of transversus thoracis muscle plane block (TTP), using repeated boluses of ropivacaine via catheter, on postoperative pain and oxycodone consumption after elective cardiac surgery with sternotomy.
Detailed Description
This randomized, double-blinded, controlled study aims to investigate the effect of transversus thoracis muscle plane block (TTP), using repeated boluses of ropivacaine via catheter, on postoperative pain and oxycodone consumption after elective cardiac surgery with sternotomy. Altogether 120 eligible patients, sixty per group, will be recruited into the study, after informed consent at the discretion of the principal investigator. All patients will receive 20 mg of temazepam orally as a premedication one hour before anaesthesia. General anaesthesia will be induced with propofol and sufentanil 0.5 μg/kg. Anaesthesia will be maintained with inhalational anaesthetic sevoflurane and sufentanil 0.005 μg ˖ kg-1 ˖ min-1 intravenous infusion. Opioids other than sufentanil will not be used before or during anaesthesia. After inclusion for the study, the patient will be randomized to one of the two study groups (G1 and G2). At the end of the surgery, when sternal wound is secured, bilateral TTP block with ultrasound guidance is performed to both groups. G1 group will receive an initial dose of 20ml placebo (NaCl 0,9%) per catheter bilaterally (total volume 40ml), followed by 20ml doses of placebo per catheter every 8 hours until 72 hours from the first dose and G2 group will receive initial dose of 20ml ropivacain 0,5% per catheter bilaterally (total volume 40ml) followed by doses of ropivacain 0,2% 20ml per catheter every 8 hours until 72 hours from the first dose has passed. All the patients will receive a patient-controlled analgesia (PCA) pump for added pain relief. After the setting of two TTP catheters, PCA pump will be attached to intravenous line and activated. Oxycodone PCA is used with 3 mg dose and lockout interval of 10 minutes. No continuous background infusion will be used during the postoperative period. When the patient is weaned from ventilator in the ICU, they are encouraged to use PCA for postoperative pain whenever necessary. If the patient is assessed to suffer from pain and is unable to use the PCA device, they will be assisted by the ICU nurse. The total duration of PCA oxycodone treatment will be 3 days (72 hours). No oral opioids or ketamine will be used. Each patients will be given 1000mg paracetamol intravenous infusion at the time of awakening and thereafter every 8 hours during TTP and PCA treatments. During recovery, the patient assess the amount of their pain using numerical rating scale (NRS, range 0-10). If the patient is sedated and/or under mechanical ventilation, behavioral pain scale (BPS) will be used to estimate the amount of pain in the ICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anesthesia, Local, Coronary Artery Disease, Heart Valve Diseases
Keywords
Transversus thoracis muscle pain block, ropivacain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G1, Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous saline (NaCl 0,9%) will be administered. G1 group will be administered an initial dose of placebo (20ml) per catheter bilaterally (total volume 40ml) after TTP has been placed. This is followed by 20ml doses of placebo per catheter every 8 hours until 72 hours from the first dose has passed.
Arm Title
G2, Ropivacaine
Arm Type
Active Comparator
Arm Description
Ropivacaine 0.5%. G2 group will be administered an initial dose of ropivacaine (20 ml) per catheter bilaterally (total volume 40ml) after the TTP has been placed. This is followed by 20 ml doses of ropivacain per catheter every 8 hours until 72 hours from the first dose has passed.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TTP block with initial dose of placebo (NaCl0.9%) 20 ml per catheter (total volume 40ml), followed by 20 ml per catheter every 8 hours until 72 hours from the first dose has passed.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
TTP block with initial dose of ropivacaine 0.5% (5 mg / ml) 20 ml per catheter (total volume 40ml), followed by doses of ropivacaine 0.2% (2 mg / ml) 20 ml per catheter every 8 hours until 72 hours from the first dose has passed.
Primary Outcome Measure Information:
Title
Number of patients with satisfactory pain response measured with visual rating scale (VAS)
Description
Number of patients with visual rating scale (VAS, 0-100 mm, min 0 mm, max 100 mm, higher score means worse outcome) value under 30 mm
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Change in opioid consumption (mg) postoperatively
Description
Change from baseline opioid consumption (mg) postoperatively at 24 hours
Time Frame
72 hours
Title
Patient reported sensation that is considered to be caused by systemic toxicity of ropivacaine.
Description
Symptoms of local anesthetic systemic toxicity (LAST) (yes/no, + mild, ++ moderate, +++ severe) including metallic taste, ringing in the ears, tremors, tongue paraesthesia, dizziness, slurred speech, muscle twitching and/or convulsions
Time Frame
72 hours
Title
Change in the length of stay in the hospital
Description
Change from baseline lenght (hours) of stay in the hospital
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 80 years of age The patient is scheduled for open cardiac coronary arterial bypass graft (CABG) OR single heart valve surgery that require median sternotomy under general anesthesia Patients that are estimated to be weaned from mechanical ventilator not later than 8 h after surgery Patients that are capable of using the patient controlled analgesia device (PCA) after surgery Written informed consent from the patient Exclusion Criteria: A previous history of intolerance to the study drug or related compounds and additives Redo surgery Combined CABG and heart valve surgery Endocarditis and/or mediastinitis. Concomitant drug therapy with strong opioids or strong CYP3A4 or CYP2D6 inductor(s) or inhibitor(s) 2 weeks prior to study. Patients younger than 18 years or older than 80 years. Body weight < 60 kg BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device. Diagnosed hepatic cirrhosis or kidney disease: GFR < 29 ml/min/1,73 m2 or dependence on dialysis History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent. If the researcher judge, that the patient has a mental health disorder, retardation or other similar reason and do not have the capacity to give his/her consent to research or patient do not understand the meaning of the study, or is not able to use PCA device, the patient is to be exluded. History of alcoholism or drug abuse (especially opioid) may affect the use of opioid PCA device and make harm to the patient or invalid the study and are exluded. Cardiac insufficiency, ejection fraction (LVEF) < 30 % Patients with a diagnosis for neuropathic pain or chronic pain syndrome Insulin dependent diabetes mellitus with neuropathy Participation in any other study concomitantly or within one month prior to the entry into this study Donation of blood for 4 weeks prior and during the study Pregnancy or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marko Peltoniemi, MD PhD
Phone
0505582333
Ext
+358
Email
marko.peltoniemi@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Teijo Saari, MD PhD
Phone
0407314041
Ext
+358
Email
teisaa@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marko Peltoniemi, MD PhD
Organizational Affiliation
Perioperative Services, Intensive Care Medicine and Pain Management; Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teijo Saari, MD, PhD
Email
teisaa@utu.fi
First Name & Middle Initial & Last Name & Degree
Tuula Manner, MD, PhD
Email
tuula.manner@tyks.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Pain Relief With Transversus Thoracis Muscle Plane Block After Cardiac Surgery

We'll reach out to this number within 24 hrs