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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004178-23 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in opioid consumption (mg) postoperatively | Change from baseline opioid consumption (mg) postoperatively at 24 hours | 72 hours |
| Patient reported sensation that is considered to be caused by systemic toxicity of ropivacaine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marko Peltoniemi, MD PhD | Perioperative Services, Intensive Care Medicine and Pain Management; Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku | Turku | Finland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | 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. |
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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
| 72 hours |
| Change in the length of stay in the hospital | Change from baseline lenght (hours) of stay in the hospital | up to 24 weeks |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000588 |
| Amines |