Pain, PostoperativePhase 4TTPcatNCT04916418
Postoperative Pain Relief With Transversus Thoracis Muscle Plane Block After Cardiac Surgery
A Phase 4 study testing Ropivacaine in people with Pain, Postoperative and Anesthesia, Local, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Local, Coronary Artery Disease
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 15 Oct 2021to 31 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku
Turku
About this study
Official title: Ultrasound Guided Repeated Bilateral Transversus Thoracis Muscle Plane Block Via Catheter and Postoperative Pain in Cardiac Surgery
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.
Read the 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.
- Being tested
- Placebo, Ropivacaine
- Keywords
- Transversus thoracis muscle pain block, ropivacain
- Medical subject headings
- Pain, Postoperative, Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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.
RopivacaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| G1, Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| G2, Ropivacaine | Active comparator | 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. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (3)
Change in opioid consumption (mg) postoperatively
Change from baseline opioid consumption (mg) postoperatively at 24 hours
Measured: 72 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
Measured: 72 hours
Change in the length of stay in the hospital
Change from baseline lenght (hours) of stay in the hospital
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start15 Oct 2021
- Primary completion1 Dec 2023
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marko Peltoniemi, MD PhD, Principal investigator, Perioperative Services, Intensive Care Medicine and Pain Management; Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916418
- Sponsor's protocol ID
- T39/2021
- Other IDs
- 2020-004178-23
- Acronym
- TTPcat
- Status last verified
- Apr 2025
- First submitted
- 27 May 2021
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Repeated Bilateral Transversus Thoracis Muscle Plane Block Via Catheter and Postoperative Pain in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04916418
- Acronym / sponsor ID
- TTPcat / T39/2021
- Keywords
- Transversus thoracis muscle pain block, ropivacain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1, Placebo | Placebo comparator | Drug: PlaceboIntravenous 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. |
| G2, Ropivacaine | Active comparator | Drug: RopivacaineRopivacaine 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTTP 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. | Drug | G1, Placebo |
| RopivacaineTTP 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. | Drug | G2, Ropivacaine |
Primary outcome
Number of patients with satisfactory pain response measured with visual rating scale (VAS)
Time frame: 72 hours
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
3 secondary outcomes
Change in opioid consumption (mg) postoperatively
Time frame: 72 hours
Patient reported sensation that is considered to be caused by systemic toxicity of ropivacaine.
Time frame: 72 hours
Change in the length of stay in the hospital
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Peltoniemi, MD PhD principal investigator
Perioperative Services, Intensive Care Medicine and Pain Management; Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Pain, Postoperative and Anesthesia, Local, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with satisfactory pain response measured with visual rating scale (VAS) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.