Bupivacaine hydrochloride; Epinephrine for Postoperative pain after aortic valve replacement | Postoperative pain after mitral valve surgery

Inclusion criteria

• {"criterion_text":"- Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy"}
• {"criterion_text":"- Adult patients (minimally 18 years old)"}
• {"criterion_text":"- EuroScore ii < 3%"}

Exclusion criteria

• {"criterion_text":"- Refusal to participate"}
• {"criterion_text":"- Class 3 obesity (BMI 40 or more)"}
• {"criterion_text":"- Intraoperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..)"}
• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Inability to communicate due to language or neurologic barriers"}
• {"criterion_text":"- Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties"}
• {"criterion_text":"- Chronic use of analgesic antidepressants and/or antiepileptics"}
• {"criterion_text":"- Chronic use of opioids"}
• {"criterion_text":"- History of major trauma or surgery to right chest wall"}
• {"criterion_text":"- History of chronic pain at right chest wall"}
• {"criterion_text":"- Allergy to opioids and/or local anesthetics"}
• {"criterion_text":"- Allergy to acetaminophen"}

Primary endpoints

• {"endpoint_text":"- Cumulative morphine consumption by PCIA at 24 hours after block placement. Information on morphine consumption will extracted from the PCIA-system after 24 hours and analyzed using 4-hour intervals.","definition_or_measurement_approach":"Information on morphine consumption will be extracted from the PCIA-system after 24 hours and analyzed using 4-hour intervals."}

Secondary endpoints

• {"endpoint_text":"- Opioid consumption will be evaluated at predetermined time intervals after performing the Serratus anterior plane block (0-4h, 4-8h, 8-12h, 12-16h, 16-20h, and 20-24h)","definition_or_measurement_approach":"Opioid consumption evaluated at predetermined time intervals (0-4h, 4-8h, 8-12h, 12-16h, 16-20h, 20-24h)."}
• {"endpoint_text":"- Number of patients that do not require any additional PCIA opioids within the first 24 hours after block placement.","definition_or_measurement_approach":"Count of patients not requiring additional PCIA opioids within first 24 hours after block placement."}
• {"endpoint_text":"- The postoperative pain on the surgical site is evaluated based on a 11-points numeric scale (Numerical Rating Sale - NRS) where 0 = no pain and 10 = worst pain ever. The NRS pain score in rest as well as with deep respiration is assessed at 4 hours, 8 hours, 12 hours and 24 hours after performing the Serratus Anterion Plane Block and at POD 7.","definition_or_measurement_approach":"NRS (0-10) scores at rest and with deep respiration at 4h, 8h, 12h, 24h and POD 7."}
• {"endpoint_text":"- Overall patient satisfaction with analgesic therapy will be assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied) 24h after performing the Serratus Anterior Plane Block at POD 1.","definition_or_measurement_approach":"11-point NRS (0-10) satisfaction score assessed 24h after SAP block (POD1)."}
• {"endpoint_text":"- Time from arrival to the ICU until extubation in minutes.","definition_or_measurement_approach":"Time in minutes from ICU arrival to extubation."}
• {"endpoint_text":"- Time from arrival to the ICU until first mobilization. According to our ERACS protocol, active patient mobilization is intended at six hours after surgery on the conditions that patients are extubated, chest tube drainage is low (<50ml/h) and patients are comfortable.","definition_or_measurement_approach":"Time from ICU arrival to first mobilization; ERACS protocol aims for mobilization at 6 hours if criteria met."}
• {"endpoint_text":"- The simplified PONV impact scale will be used to assess PONV 24h after performing the SAP block at POD 1. Clinically important PONV will be defined as a score of 5 or more.","definition_or_measurement_approach":"Simplified PONV impact scale at 24h; clinically important PONV defined as score ≥5."}
• {"endpoint_text":"- Time to first defecation (postoperative days) or need for laxatives during hospital stay (number of patients)","definition_or_measurement_approach":"Time to first defecation in postoperative days and count of patients needing laxatives during hospital stay."}
• {"endpoint_text":"- Time from arrival to the ICU until meeting discharge criteria to the ward in postoperative hours.","definition_or_measurement_approach":"Time in postoperative hours from ICU arrival until meeting discharge criteria to ward."}
• {"endpoint_text":"- Time to discharge out of the hospital in postoperative days (day of surgery = day 0)","definition_or_measurement_approach":"Time to hospital discharge in postoperative days (day 0 = day of surgery)."}
• {"endpoint_text":"- Pneumonia defined as empirical antibiotic therapy for suspicion of pneumonia during hospital stay, in number of patients.","definition_or_measurement_approach":"Number of patients treated empirically with antibiotics for suspected pneumonia during hospital stay."}
• {"endpoint_text":"- Serum bupivacaine levels have never been recorded after SAPB. In the first 36 study patients, arterial blood samples will be taken at 30minutes as well as at 1, 2, 4 and 8 hours after block placement for dosage of total and free plasma bupivacaine levels.","definition_or_measurement_approach":"In first 36 patients, arterial blood samples at 30 min, 1h, 2h, 4h, 8h after block for total and free plasma bupivacaine levels."}
• {"endpoint_text":"- Quality of recovery will be assessed at POD 2 and POD 7 with Quality of Life questionnaires: EQ5D and short form health survey (SF-36).","definition_or_measurement_approach":"Quality of recovery assessed at POD2 and POD7 with EQ-5D and SF-36 questionnaires."}

Belgium

Earliest CTIS Part Ii Submission Date

26-01-2024

Latest Decision Or Authorization Date

15-04-2024

Processing Time Days

80

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Jessa Ziekenhuis

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium