Jessa hospital
Hasselt, Limburg, 3500, Belgium
Location status: Recruiting
Location contact
Björn Stessel, Dr.
CONTACT
Ina Callebaut, PhD
CONTACT
NCT Number: NCT06205875
This study aims to compare the efficacy and quality of pain relief provided by the high-dose serratus anterior plane (SAP) block with the standard SAP block in preventing and treating acute postoperative pain after total endoscopic aortic or mitral valve surgery.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Hasselt, Limburg, 3500, Belgium
Location status: Recruiting
Björn Stessel, Dr.
CONTACT
Ina Callebaut, PhD
CONTACT
During the last two decades, cardiac surgical techniques have changed dramatically. Evidence for good short and long-term outcomes after endovascular and minimally invasive procedures is rising. This shift made it possible to avoid sternotomy and thus facilitating earlier patient recovery without compromising safety. Therefore, enhanced recovery after surgery (ERAS) protocols have been implemented to aim for early extubation and ambulation. While policies for early extubation and discharge from the hospital have been implemented, the analgesic regimen has not been modified. Opioids remain the standard treatment in the postoperative setting after cardiac surgery despite known side effects such as nausea, constipation and the risk of addiction. Neuraxial anaesthesia techniques, which require fewer opioids in cardiac surgery, have been studied and validated but not yet implemented.
In 2013, the serratus anterior plane (SAP) block was described as a pain relief option for chest surgery. This anaesthesia technique injects local anaesthetics under the serratus muscle and between the latissimus dorsi and serratus anterior using ultrasound. Successful pain relief with this SAP block has been reported in thoracotomy, chest surgery, and rib fractures. In our previous study, we demonstrated a 40% reduction in morphine consumption during the first 24 hours after total endoscopic aortic valve replacement with an SAP block compared to a control group without an SAP block. Lower pain scores were also observed in the SAP group
As such, in this proposed study, we aim to optimise the intensity of the Serratus anterior plane block (SAPB) to decrease opioid requirements further and to encounter more favourable secondary clinical outcome parameters. One strategy to increase the duration of action of plane blocks is injecting higher doses of local anaesthetics. A meta-analysis by De Oliveira et al. on transabdominal plane (TAP)-blocks for abdominal surgery showed a correlation between the local anaesthetic dose and the late block effect, impacting both pain scores and opioid consumption. In a randomised controlled trial by Suresh, a TAP block with bupivacaine 1.25 mcg/kg was compared to a TAP block with bupivacaine 2.5 mcg/kg, revealing a longer duration of analgesia and a lower need for additional analgesics up to 24 hours post-surgery. Moreover, loading doses up to 2mg/kg body weight are recommended for truncal blocks in general, but the mean injected dose in our intervention group was 1.25mg/kg, considering a mean patient body weight of 79.2kg. Notably, a pharmacokinetic study by Maximos and colleagues on an adrenalised bupivacaine mixture after pectointercostal fascial plane block (PIFB) after cardiac surgery showed that, despite injecting 2mcg/kg adrenalised bupivacain, both total and free arterial serum bupivacaine levels were 10-20 times lower than levels associated with neurologic or cardiovascular toxicity in the literature.
In conclusion, we are convinced we can safely improve the late effects of our SAPB compared to our first study by increasing the dose of the local anesthetic injectate.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The needle will be introduced in-plane from supero-anterior to postero-inferior until the needle tip is positioned in the plane underneath the serratus muscle (deep compartment). Under continuous ultrasound guidance, 3/4th of the bupivacaine 0.25% plus epinephrine solution will be injected in the deep compartment. After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues. The needle will be flattened and advanced in-plane to the plane superficial to the serratus muscles. The remainder quarter of the bupivacaine 0.25% plus epinephrine solution will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound. In total a dose of 2.4mg/kg patient ideal body weight will be administered. There is a maximal dose of 200 mg adrenalized bupivacaine for patients with an ideal body weight of 83 kg or more.
The needle will be introduced in-plane from supero-anterior to postero-inferior until the needle tip is positioned in the plane underneath the serratus muscle (deep compartment). Under continuous ultrasound guidance, 3/4th of the bupivacaine 0.25% will be injected in the deep compartment. After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues. The needle will be flattened and advanced in-plane to the plane superficial to the serratus muscles. The remainder quarter of the bupivacaine 0.25% will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound.
A patient controlled intravenous analgesia system (Bodyguard 595 Colorvision®) with morphine (Sterop®) using following settings: bolus 1.5 mg and lockout interval 7 min with maximal dose of 30mg per 4 hours.
Other names: PCIA with Sterop
Time frame: 24 hours after block placement
Morphine consumption will be directly read from the PCIA-system after 24 hours
Time frame: Every 4 hours until 24 hours after placement of the SAP block
Morphine consumption will be directly read from PCIA-system at predetermined time intervals after performing the SAP block.
Time frame: First 24 hours
Number of patients that do not require any additional opioids within the first 24 hours after block placement.
Time frame: 4, 8, 12 and 24 hours after performing the SAP block and at postoperative day 7.
The postoperative pain in rest, as well as with deep respiration on the surgical site, is evaluated based on an 11-point numeric scale (NRS) where 0 = no pain and 10 = worst pain ever.
Time frame: 24 hours after performing the SAP block at postoperative day 1.
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)
Time frame: Throughout study completion, an average of 7 days
Time from arrival to the ICU until extubation in minutes.
Time frame: Intended at 6 hours after surgery
Time from arrival to the ICU until first mobilization.
Time frame: 24 hours after performing the SAP block at postoperative day 1
The simplified PONV impact scale will be used to asses PONV. Clinically important PONV will be defined as a score of 5 or more.
Time frame: Until postoperative day 7
Time to first defecation (postoperative days) or need for laxatives during hospital stay (number of patients)
Time frame: Until postoperative day 7
Time from arrival to the ICU until meeting discharge criteria to the ward in postoperative hours.
Time frame: Throughout study completion, an average of 7 days
Time to discharge out of the hospital in postoperative days (day of surgery = day 0)
Time frame: Until postoperative day 7
Defined as empirical antibiotic therapy for suspicion of pneumonia during hospital stay, in number of patients.
Time frame: At postoperative day 2 and 7
Quality of recovery will be assessed with Quality of Life questionnaires: EuroQol*5D (EQ5D) and short form health survey (SF-36).
Time frame: at 30minutes as well as at 1, 2, 4 and 8 hours after block placement
In the first 36 study patients, arterial blood samples will be taken to calculate the dosage of total and free plasma bupivacaine levels. For each patient 5 samples will be collected, with a total amount of 50 ml blood per patient.
Contact information is provided by the study sponsor or research team.
Björn Stessel, Dr
CONTACT
Ina Callebout, PhD
CONTACT
Jessa Hospital
Other
High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery: a Double-blinded Randomized Controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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