AnalgesiaNCT04699422
Serratus Anterior Plane Block Versus Standard of Care After Totally Endoscopic Aortic Valve Replacement
A study testing Serratus anterior plane block and PCIA with Piritramide in people with Analgesia and Surgery, run by Jessa Hospital at 1 site in Belgium.
Trial summary
The aim of this study is to assess and compare the efficacy of a serratus anterior plane (SAP) block and our current pain protocol (Patient Controlled Intravenous Analgesia with opioids) in the prevention and treatment of acute postoperative pain after totally endoscopic aortic valve replacement (AVR) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Surgery, Cardiac Disease
- What is being tested?
- Serratus anterior plane block and PCIA with Piritramide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Dec 2020to 4 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective aortic valve replacement surgery via right anterolateral thoracotomy
- Adult patients (minimally 18 years old)
- EuroScore ii < 3%
- Bodyweight > 50 kg
Who cannot join
- 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
- Chronic use of analgesic antidepressants and/or antiepileptics
- History of major trauma or surgery to right chest wall
Show all 12Show fewer
- History of chronic pain at right chest wall
- Allergy to opioids and/or local anesthetics
- Allergy to acetaminophen
- Morbid obesity (BMI > 35)
- Pregnancy
- Peroperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, ..)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serratus Anterior Plane Block Versus Standard of Care After Totally Endoscopic Aortic Valve Replacement: a Double-blinded Randomized Controlled Trial.
The aim of this study is to assess and compare the efficacy of a serratus anterior plane (SAP) block and our current pain protocol (Patient Controlled Intravenous Analgesia with opioids) in the prevention and treatment of acute postoperative pain after totally endoscopic aortic valve replacement (AVR) surgery.
Read the detailed description
During the last two decades, cardiac surgical techniques changed dramatically. Evidence for good short and long-term outcome after endovascular and minimally invasive procedures is rising. The goal of avoiding sternotomy is earlier patient recovery without compromising safety. Therefore, enhanced recovery after surgery (ERAS) protocols have been implemented to aim for early extubation and ambulation. Analgesic regimens after cardiac surgery did not change significant however. Opioids remain the cornerstone of analgesia in the postoperative cardiac surgical care units, despite known side effects as nausea, constipation and risk for addiction. Neuraxial anesthetic techniques after cardiac surgery have been studied and validated to reduce opioid consumption. Their implementation in clinical practice however remains limited for two reasons. First, heparinization is required for cardiac surgery, which increases the risk neuraxial hematoma after neuraxial anesthesia, leading to deleterious complications as paraplegia. Secondly, neuraxial anesthesia induces orthosympathicolysis, enhancing vasoplegia after cardiac surgery. However, fascial plane blocks in cardiac surgery since peripheral blocks do not induce sympathicolysis and consequences of chest wall hematoma are limited.
In 2013, Blanco described the serratus anterior plane (SAP) block as an analgesic option for chest wall surgery. In this fascial plane block, local anesthetics are injected in the plane beneath the anterior serratus muscle and in the plane between latissimus dorsi and serratus anterior in an ultrasound guided manner. SAP block provides analgesia in dermatomes T2-T9. Recently, successful analgesia after SAP block has been demonstrated for soft tissue chest wall surgery, thoracotomy and rib fractures. No major side effects were reported. More specifically, no sympatholytic effects or chest wall hematoma were observed. However, up to now no prospective studies assessing the analgesic efficacy of SAP block after cardiac surgery are published. Two retrospective studies show conflicting results. Berthoud et al. retrospectively compared SAP block to continuous wound infusion after different types of minimally invasive cardiac surgery (MICS) and found reduced morphine consumption as well as shorter intensive care and hospital length of stay after SAP block. In contrast, Moll et al. found no difference in opioid consumption between SAP block and no block in patients after robotic coronary artery bypass grafting (rCABG). The authors comment they only performed the deep component of the SAP block, and some surgical entry points were outside dermatomes T2-T7.
Totally endoscopic aortic valve replacement (AVR) is a novel minimally invasive cardiosurgical technique. Surgical incision is made anteriorly in intercostal space two on the right hemithorax. Since intercostal space two is innervated by dermatomes T2-T3, somatic analgesia can be obtained with SAP block. In addition with a favorable safety profile and a minimal/non-existent risk of evoking sympatholytic effects, a SAP block may be a suitable analgesic technique to prevent/minimize postoperative pain after totally endoscopic AVR surgery.
- Conditions
- Analgesia, Surgery, Cardiac Disease
- Being tested
- Serratus anterior plane block, PCIA with Piritramide
- Medical subject headings
- Agnosia, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior plane blockProcedure or 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,30 cc Bupivacaine 0.25% will be injected in the deep compartment. After the deep component of the SAP 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. 10 cc Bupivacaine 0.25% will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound
PCIA with PiritramideDrug
Also called PCIA with Dipidolor
A patient controlled intravenous analgesia system (IVAC PCAM®, Cardinal Health or CADD pump) with piritramide (Dipidolor®, Janssen) using following settings: bolus 2 mg and lockout interval 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Patients in the experimental group will receive the serratus anterior plane block combined with postoperative PCIA with Piritramide. Receives: Procedure: Serratus anterior plane block; Drug: PCIA with Piritramide |
| Control group | Sham comparator | Patients in the control group will receive postoperative PCIA with Piritramide. Receives: Drug: PCIA with Piritramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)
Piritramide consumption (mg) will be directly read from the PCIA-system after 24 hours.
Measured: 24 hours after performing the SAP block
Secondary outcomes (15)
Opioid consumption during predetermined time intervals after surgery
Piritramide consumption (mg) will be directly read from the PCIA-system at predetermined time intervals after performing the SAP block.
Measured: Every 4 hours until 24 hours after placement of the SAP block
Opioid free patients first 24 postoperative hours
Number of patients that do not require any opioids within the first 24 hours after surgery.
Measured: First 24 hours
Opioid free patients during hospital length of stay
Number of patients that do not require any opioids during the hospital length of stay
Measured: Through study completion, an average of 7 days
Postoperative pain score in rest
The postoperative pain on the surgical site is evaluated based on an 11-points numeric scale (Numerical Rating Sale - NRS) where 0 = no pain and 10 = worst pain ever.
Measured: 4, 8, 12, and 24 hours after performing the SAP block and at postoperative day 7.
Quality of recovery after totally endoscopic aortic valve replacement
Quality of recovery will be assessed via the 5-Dimensional European Quality of Life (EQ5D) and 36-Item Short Form Health Survey (SF-36) questionnaires concerning mobility, self care, daily activities and pain.
Measured: Postoperative days 2 and 7
Overall patient satisfaction with analgesic therapy
Overall patient satisfaction with analgesic therapy will be assessed with an 11-point Numeric Rating Scale (where 0 = not satisfied at all and 10 = extremely satisfied).
Measured: 24 hours after performing the serratus anterior plane block at postoperative day 1
Postoperative nausea and vomiting (PONV)
The simplified postoperative nausea and vomiting (PONV) impact scale will be used to assess PONV. The scale ranges from 0 to 6, where 0 means no nausea/vomiting. Clinically important PONV will be defined as a score of 5 or more.
Measured: 24 hours after performing the serratus anterior plane block at postoperative day 1
Constipation
Time to first defecation (postoperative days) or need for laxatives during hospital stay.
Measured: Until postoperative day 7
Time to extubation
Time from arrival to the ICU until extubation in minutes.
Measured: Throughout study completion, an average of 7 days
ICU length of stay
Time from arrival to the ICU until meeting discharge criteria to the ward in postoperative hours.
Measured: Until postoperative day 7
Hospital length of stay
Time to discharge out of the hospital in postoperative days (day of surgery = day 0)
Measured: Through study completion, an average of 7 days
Pneumonia
Defined as empirical antibiotic therapy for suspicion of pneumonia during hospital stay, in number of patients.
Measured: Until postoperative day 7
Duration of vasopressor infusion
Time from arrival to the ICU until full weaning from vasoactive substances (eg norepinephrine) in minutes. Patients not requiring any vasopressors will be excluded from this secondary outcome parameter.
Measured: Until postoperative day 7
Subcutaneous emphysema
Number of patients suffering subcutaneous emphysema. All patients will be investigated 24h after performing the SAP block (or control) by a blinded assessor.
Measured: 24 hours after performing the serratus anterior plane block at postoperative day 7
Number of patients with new onset perioperative atrial fibrillation (POAF)
Number of patients suffering witnessed (ECG recorded) POAF and patients with history of (paroxysmal) atrial fibrillation will not be taken into account for this secondary outcome parameter.
Measured: Until postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start3 Dec 2020
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is designed as a mono-center, double-blinded, prospective, randomized controlled superiority trial comparing 2 groups of patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699422
- Sponsor's protocol ID
- JessaH_SAPblock
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2020
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vandenbrande J, Jamaer B, Stessel B, van Hilst E, Callebaut I, Yilmaz A, Packle L, Sermeus L, Blanco R, Jalil H. Serratus plane block versus standard of care for pain control after totally endoscopic aortic valve replacement: a double-blind, randomized controlled, superiority trial. Reg Anesth Pain Med. 2024 Jun 3;49(6):429-435. doi: 10.1136/rapm-2023-104439.
PubMed 37597856
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block Versus Standard of Care After Totally Endoscopic Aortic Valve Replacement: a Double-blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04699422
- Acronym / sponsor ID
- JessaH_SAPblock
- Conditions
- Analgesia, Surgery, Cardiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess and compare the efficacy of a serratus anterior plane (SAP) block and our current pain protocol (Patient Controlled Intravenous Analgesia with opioids) in the prevention and treatment of acute postoperative pain after totally endoscopic aortic valve replacement (AVR) surgery.
Detailed description
During the last two decades, cardiac surgical techniques changed dramatically. Evidence for good short and long-term outcome after endovascular and minimally invasive procedures is rising. The goal of avoiding sternotomy is earlier patient recovery without compromising safety. Therefore, enhanced recovery after surgery (ERAS) protocols have been implemented to aim for early extubation and ambulation. Analgesic regimens after cardiac surgery did not change significant however. Opioids remain the cornerstone of analgesia in the postoperative cardiac surgical care units, despite known side effects as nausea, constipation and risk for addiction. Neuraxial anesthetic techniques after cardiac surgery have been studied and validated to reduce opioid consumption. Their implementation in clinical practice however remains limited for two reasons. First, heparinization is required for cardiac surgery, which increases the risk neuraxial hematoma after neuraxial anesthesia, leading to deleterious complications as paraplegia. Secondly, neuraxial anesthesia induces orthosympathicolysis, enhancing vasoplegia after cardiac surgery. However, fascial plane blocks in cardiac surgery since peripheral blocks do not induce sympathicolysis and consequences of chest wall hematoma are limited.
In 2013, Blanco described the serratus anterior plane (SAP) block as an analgesic option for chest wall surgery. In this fascial plane block, local anesthetics are injected in the plane beneath the anterior serratus muscle and in the plane between latissimus dorsi and serratus anterior in an ultrasound guided manner. SAP block provides analgesia in dermatomes T2-T9. Recently, successful analgesia after SAP block has been demonstrated for soft tissue chest wall surgery, thoracotomy and rib fractures. No major side effects were reported. More specifically, no sympatholytic effects or chest wall hematoma were observed. However, up to now no prospective studies assessing the analgesic efficacy of SAP block after cardiac surgery are published. Two retrospective studies show conflicting results. Berthoud et al. retrospectively compared SAP block to continuous wound infusion after different types of minimally invasive cardiac surgery (MICS) and found reduced morphine consumption as well as shorter intensive care and hospital length of stay after SAP block. In contrast, Moll et al. found no difference in opioid consumption between SAP block and no block in patients after robotic coronary artery bypass grafting (rCABG). The authors comment they only performed the deep component of the SAP block, and some surgical entry points were outside dermatomes T2-T7.
Totally endoscopic aortic valve replacement (AVR) is a novel minimally invasive cardiosurgical technique. Surgical incision is made anteriorly in intercostal space two on the right hemithorax. Since intercostal space two is innervated by dermatomes T2-T3, somatic analgesia can be obtained with SAP block. In addition with a favorable safety profile and a minimal/non-existent risk of evoking sympatholytic effects, a SAP block may be a suitable analgesic technique to prevent/minimize postoperative pain after totally endoscopic AVR surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is designed as a mono-center, double-blinded, prospective, randomized controlled superiority trial comparing 2 groups of patients
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Procedure: Serratus anterior plane block, Drug: PCIA with PiritramidePatients in the experimental group will receive the serratus anterior plane block combined with postoperative PCIA with Piritramide. |
| Control group | Sham comparator | Drug: PCIA with PiritramidePatients in the control group will receive postoperative PCIA with Piritramide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for elective aortic valve replacement surgery via right anterolateral thoracotomy
- Adult patients (minimally 18 years old)
- EuroScore ii < 3%
- Bodyweight > 50 kg
Key exclusion criteria (12 listed)
- 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
- Chronic use of analgesic antidepressants and/or antiepileptics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serratus anterior plane blockThe 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,30 cc Bupivacaine 0.25% will be injected in the deep compartment. After the deep component of the SAP 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. 10 cc Bupivacaine 0.25% will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound | Procedure or surgery | Experimental group |
| PCIA with PiritramideAlso: PCIA with DipidolorA patient controlled intravenous analgesia system (IVAC PCAM®, Cardinal Health or CADD pump) with piritramide (Dipidolor®, Janssen) using following settings: bolus 2 mg and lockout interval 15 min. | Drug | Control group, Experimental group |
Primary outcome
Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA)
Time frame: 24 hours after performing the SAP block
Piritramide consumption (mg) will be directly read from the PCIA-system after 24 hours.
15 secondary outcomes
Opioid consumption during predetermined time intervals after surgery
Time frame: Every 4 hours until 24 hours after placement of the SAP block
Opioid free patients first 24 postoperative hours
Time frame: First 24 hours
Opioid free patients during hospital length of stay
Time frame: Through study completion, an average of 7 days
Postoperative pain score in rest
Time frame: 4, 8, 12, and 24 hours after performing the SAP block and at postoperative day 7.
Quality of recovery after totally endoscopic aortic valve replacement
Time frame: Postoperative days 2 and 7
Overall patient satisfaction with analgesic therapy
Time frame: 24 hours after performing the serratus anterior plane block at postoperative day 1
Postoperative nausea and vomiting (PONV)
Time frame: 24 hours after performing the serratus anterior plane block at postoperative day 1
Constipation
Time frame: Until postoperative day 7
Time to extubation
Time frame: Throughout study completion, an average of 7 days
ICU length of stay
Time frame: Until postoperative day 7
Hospital length of stay
Time frame: Through study completion, an average of 7 days
Pneumonia
Time frame: Until postoperative day 7
Duration of vasopressor infusion
Time frame: Until postoperative day 7
Subcutaneous emphysema
Time frame: 24 hours after performing the serratus anterior plane block at postoperative day 7
Number of patients with new onset perioperative atrial fibrillation (POAF)
Time frame: Until postoperative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 37597856Vandenbrande J, Jamaer B, Stessel B, van Hilst E, Callebaut I, Yilmaz A, Packle L, Sermeus L, Blanco R, Jalil H. Serratus plane block versus standard of care for pain control after totally endoscopic aortic valve replacement: a double-blind, randomized controlled, superiority trial. Reg Anesth Pain Med. 2024 Jun 3;49(6):429-435. doi: 10.1136/rapm-2023-104439.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus anterior plane block and PCIA with Piritramide in people with Analgesia and Surgery, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption by patient-controlled intravenous analgesia (PCIA) (time frame: 24 hours after performing the SAP block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.