A Phase 3 interventional study of Ropivacaine 0.2% Injectable Solution and Ropivacaine 0.2% + Dexamethasone in Spine Erector, Cardiac Surgery and Acute Pain, sponsored by Instituto do Coracao. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Instituto do Coracao · Phase 3, Interventional, and Prevention
Open cardiac surgeries are characterized by the increased use of opioids and longer extubation times, being post-sternotomy pain one of the causes of greater patient discomfort, plexus blockages have been used more frequently given the good results of anatomical studies and case series that are just beginning to be published. however, there is not enough data to convince the scientific community of its advantages, continuing to carry out its performance due to lack of evidence. Dexamethasone also shows an excellent result blocking the inflammatory chain and it was evidenced that it prolongs the time of blockages when used perineurally in the plexus blockages. This study wants to show the improvement of pain in patients who undergo this type of surgery and also show the advantages of a longer blockage, which can reduce use of analgesic and opioids, as well as decrease the time of hospitalization This is a double-blinded, randomized, clinical trial designed to determine the efficacy of spine erector whit dexamethasone gives more duration of the blockage and less pain after cardiac surgery.
Evaluation of acute pain pos cardiac surgery in patients that who were subjected at myocardial revascularization. We offer Espine erector block (ESP) with linear array Transducer and needle 100mm bilateral as a technique that offer results more hopeful and less invasive in patients with open cardiac surgery. Favoring the implementation of Fastrack anesthesia techniques in cardiac surgery and minimizing complications in this group of patients
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's planned enrollment of 40 is below the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Instituto do Coracao is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients assigned for local anesthetic group will receive a single-shot ultrasound-guided erector spine plane block with 25 mL of 0.2% of ropivacaine
Drug: Ropivacaine 0.2% Injectable Solution
Patients assigned for local anesthetic + steroid group will receive a single-shot ultrasound-guided erector spine block plane with 25 mL of 0.2% of ropivacaine with 5 mg dexamethasone
Drug: Ropivacaine 0.2% Injectable Solution · Drug: Ropivacaine 0.2% + Dexamethasone
Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine
Also known as: Do not have
Drug page: Ropivacaine
Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution
Also known as: Do not have
Pain intensity score
Changes in Numeric Rating Scale (NRS) and visual analogue scale (VAS) will be recorded daily at postoperative 1 to 7 day or until the patient's hospital discharge if this occurs before 7 days. * Numerical rating scales A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable * VAS have also been utilized in EMA research. VAS are measures of subjective or behavioral experience (e.g., pain, physical exercise). They are typically presented as a 10 cm line with descriptive anchors at each end, such as "completed all prescribed activities today" to "completed none of the prescribed activities today." Respondents place a vertical line through the point on the scale that best fits their experience with that construct at that moment.
Time frame: Within 7 days after cardiac surgery
Total opioids consumption
The total amount of opioids given by patient
Time frame: Up to 2 postoperative day
Pain intensity score
Changes inThe Brief Pain Inventory (BPI).will be recorded after discharge at 30 days, 60 days and 90 days after surgery \*The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning; BPI Pain Items, Least pain in last 24 hours, Pain on average, Pain right now, Worst pain in last 24 hours; BPI Interference Items, Mood, Walking ability, Normal work (including housework), General activity, Relations with other people, Sleep, Enjoyment of life
Time frame: Up to 90 days
Duration of mechanical ventilation
Duration in hours from the intraoperative intubation up to postoperative extubation
Time frame: Within 7 days after cardiac surgery
Started Jan 2022 (actual). Primary completion is estimated for Feb 2023, 13 months after the start.
Of 25 non-industry phase 3 interventional studies under Acute Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 27. This study's planned 13 months is below that.
Counting every sponsor, half of 53 studies reached it within 14 months; a quarter within 7 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine
Instituto do Coracao