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High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.

ConditionsAnalgesiaSurgeryCardiac DiseasePost Operative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJessa Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy

Adult patients (minimally 18 years old)

Bodyweight > 50kg

EuroScore ii < 3%

Disqualifiers

Refusal to participate

Inability to communicate due to language or neurologic barriers

Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties

Chronic use of opioids

Trial design

Design model

Parallel

Treatments tested in this trial

  • High dose serratus anterior plane block (2.4 mg/kg patient ideal body weight)

    Procedure/Surgery

    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 After the deep component of the serratus anterior plane block is completed, the needle will be withdrawn to the subcutaneous tissues.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.

  • Low dose serratus anterior plane block (1.2mg/kg patient ideal body weight)

    Procedure/Surgery

    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.

  • PCIA with morphine

    Drug

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)

Morphine consumption will be directly read from the PCIA-system after 24 hours

Time frame
24 hours after block placement

Secondary outcomes

1

Opioid consumption during predetermined time intervals after surgery

Morphine consumption will be directly read from PCIA-system at predetermined time intervals after performing the SAP block.

Time frame
Every 4 hours until 24 hours after placement of the SAP block
2

Opioid free patients first 24 postoperative hours

Number of patients that do not require any additional opioids within the first 24 hours after block placement.

Time frame
First 24 hours
3

Postoperative pain score in rest and on deep respiration

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
4, 8, 12 and 24 hours after performing the SAP block and at postoperative day 7.
4

Overall patient Satisfaction with analgesic therapy

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
24 hours after performing the SAP block at postoperative day 1.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jessa Hospital

Lead sponsor

Source ClinicalTrials.gov
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