Thoracic DiseasesSAPBNCT03768193
Deep Serratus Anterior Plane Block vs Surgically-placed Paravertebral Block for VATS Surgery
A study testing Deep serratus anterior plane block and Surgically-placed paravertebral block in people with Thoracic Diseases and Thoracic Surgery, run by Mater Misericordiae University Hospital at 1 site in Ireland.
Trial summary
Thoracic surgery, and surgery involving the chest wall in general, is associated with poorly controlled acute pain, which may result in delayed functional recovery, and may progress to chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Diseases, Thoracic Surgery, Rib Fractures
- What is being tested?
- Deep serratus anterior plane block and Surgically-placed paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 4 Oct 2017to 1 Sep 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults greater than or equal to 18 years of age presenting for minimally-invasive thoracic surgery.
Who cannot join
- Patient refusal.
- Local infection at site of insertion.
- Allergy to amide local anaesthetics, opioids, paracetamol, NSAIDs, ketamine, NMBs, volatile anaesthetics.
- Concurrent use of antiarrhythmics with local anaesthetic activity.
- Concurrent use of MAOIs or within 2 weeks of MAOI use.
- Severe renal, liver or cardiac dysfunction.
Show all 10Show fewer
- Coagulopathy/ anticoagulants that preclude use of PVB/ SAP techniques.
- Inability to comprehend pain scoring system.
- Elderly or frail patients that require a reduction in levobupivacaine dose commensurate with their physical status, resulting in the protocol not being followed.
- Pregnancy, breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-guided Continuous Serratus Anterior Plane Blockade With Continuous Thoracic Paravertebral Blockade for Perioperative Analgesia Following Video-assisted Thoracoscopic Surgery (VATS)
Thoracic surgery, and surgery involving the chest wall in general, is associated with poorly controlled acute pain, which may result in delayed functional recovery, and may progress to chronic pain. Multimodal opioid-sparing analgesia regimens are a key component of the thoracic surgery enhanced recovery pathway, the aim of which is to improve outcomes in patients undergoing both minimally invasive and open thoracic surgical procedures. Novel interfascial plane blocks are emerging as feasible alternatives to central neuraxial analgesia techniques in a variety of clinical settings.
The aim of this study is to show non-inferiority of serratus anterior blockade compared with surgically placed paravertebral blocks in the management of perioperative acute pain in patients undergoing VATS procedures.
Read the detailed description
Post-thoracotomy pain syndrome is an unwanted complication of thoracic surgery. Poorly controlled pain may precipitate increased morbidity in the immediate and early postoperative periods due to its adverse effects on respiratory mechanics and mobilisation, which may result in further morbidity such as postoperative pulmonary complications and thrombosis. Poor perioperative management of this pain may also result in the development of chronic pain. Enhanced recovery, particularly functional recovery has become an important goal in the perioperative management of our patients. A key principle of this pathway is multimodal opioid-sparing analgesia to facilitate improved recovery and patient outcomes. Regional anaesthesia forms the cornerstone of this multimodal analgesia regimen.
Traditionally, thoracic epidural and thoracic paravertebral blockade have been the main forms of regional anaesthesia utilised in thoracic surgical patients undergoing lung resection. With the increasing use of minimally invasive thoracic surgery and with a cohort of patients who may not always be suitable for central neuraxial blockade, alternatives are needed. More recently, there has been an emerging use of interfascial plane blocks in this patient group. The interest in these techniques is derived from case reports, case series, cadaveric studies, and small clinical trials, which have demonstrated clinical efficacy in a variety of elective and emergency thoracic surgical procedures and also in chronic thoracic pain syndromes.
The deep serratus anterior plane (deep SAP) block is a relatively new interfascial plane regional anaesthesia technique, which has been postulated to provide analgesia of the entire hemithorax. The mechanism of its analgesic effects are believed to occur via blockade of the lateral cutaneous branches of the thoracic intercostal nerves (T2-T12), which produces analgesia of the anterolateral chest wall. A recent anatomical study by Mayes et al. demonstrated consistent blockade of the lateral cutaneous branches of the intercostal nerves. Clinical studies, although small, have shown dermatomal spread in the T2 - T9 distribution of the anterolateral chest wall. Therefore, this block presents a potential alternative to central neuraxial blockade.
However, whether SAP blockade can produce non-inferior analgesia compared with either thoracic epidural or thoracic paravertebral, both in terms of somatic +/- autonomic blockade, and the reliability of dermatomal spread, has been questioned by some.
The aim of this randomised controlled trial is to demonstrate non-inferiority of ultrasound-guided continuous deep serratus anterior plane blockade compared with surgically-placed continuous paravertebral blockade, for perioperative analgesia, in the patients undergoing minimally-invasive videoscopic thoracic surgery.
- Conditions
- Thoracic Diseases, Thoracic Surgery, Rib Fractures, Pain, Postoperative, Pain, Procedural, Anaesthesia, Regional
- Being tested
- Deep serratus anterior plane block, Surgically-placed paravertebral block
- Medical subject headings
- Thoracic Diseases, Rib Fractures, Pain, Postoperative, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep serratus anterior plane blockProcedure or surgery
Deposition of local anaesthetic in the space between the serratus anterior muscle and the external intercostal muscle, at the level of the 4th-5th rib, in the midaxillary line. Procedure performed under ultrasound guidance. Catheter - based infusion of local anaesthetic into this space for 48 hours.
Surgically-placed paravertebral blockProcedure or surgery
Surgically-placed paravertebral block catheters for continuous local anaesthetic infusion of 0.125% levobupivacaine at 8-12mls/ hr for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Deep serratus anterior plane block | Experimental | Ultrasound-guided deposition of 40mls of 2mg/ kg levobupivacaine into the deep serratus anterior plane space, in the mid axillary line, at the level of the 4th/5th rib. Insertion of a continuous local anaesthetic infusion catheter(Portex™) and continuation of an infusion of 0.125% levobupivacaine at a rate of 8-12mls/ hour for 48 hours. Receives: Procedure: Deep serratus anterior plane block |
| Surgically-placed paravertebral block | Active comparator | Surgical placement of paravertebral local anaesthetic infusion catheters (Portex™) prior to closure. Bolus of levobupivacaine as per protocol. Continuation of an infusion of 0.125% levobupivacaine at a rate of 8-12mls/ hour for 48 hours. Receives: Procedure: Surgically-placed paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Expressed as oral morphine equivalent
Measured: Over the first 48 hours postoperatively
Secondary outcomes (9)
Postoperative numerical pain scores
Numerical rating scale. 0 - 10. 0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain.
Measured: Over the first 48 hours postoperatively
Opioid side - effects - 1
Sedation scale. 0 = wide awake, 1 = drowsy but responds to normal verbal communication, 2 = asleep, but awakes with verbal communication. 3 = asleep, awakens with mild physical stimulation. 4 = asleep, unresponsive to physical stimulation.
Measured: Over the first 48 hours postoperatively
Opioid side - effects - 2
Nausea/ vomiting scale. Questionnaire. 0= none, 1=mild, 2=moderate, 3=severe
Measured: Over the first 48 hours postoperatively
Opioid side - effects - 3
Itch/ Pruritis scale 0= none, 1=mild, 2=moderate, 3=severe
Measured: Over the first 48 hours postoperatively
Mean arterial blood pressure
Calculated from systolic and diastolic blood pressure.
Measured: Over the first 48 hours postoperatively.
Presence of dermatomal sensory block distribution
Dermatomal sensory block distribution
Measured: Within the first 24 hours postoperatively
Functional assessment
Walking distance in meters assessed by physiotherapist
Measured: Within the first 48 hours postoperatively
Patient satisfaction
Subjective patient satisfaction scale. Subjective scale assessing Level of overall patient satisfaction with perioperative analgesia. Patient rates their experience as either 1 = insufficient, 2 = sufficient, 3 = very good, 4 =excellent.
Measured: Over the first 48 hours postoperatively
Duration of inpatient hospital admission
Measured in days.
Measured: From date of admission for surgery to date of discharge by the thoracic team; through to study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start4 Oct 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
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 Thoracic DiseasesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mater Misericordiae University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Conor Hearty, Mater Misericordiae University Hospital
- Investigators
- Conor Hearty, FFPMCAI,FFPMANZCA,FCARCSI,FIPP, Principal investigator, Consultant Anaesthetist, Mater Misericordiae University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768193
- Sponsor's protocol ID
- 1/378/1918
- Acronym
- SAPB
- Status last verified
- Dec 2018
- First submitted
- 27 Sep 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hanley C, Wall T, Bukowska I, Redmond K, Eaton D, Ni Mhuircheartaigh R, Hearty C. Ultrasound-guided continuous deep serratus anterior plane block versus continuous thoracic paravertebral block for perioperative analgesia in videoscopic-assisted thoracic surgery. Eur J Pain. 2020 Apr;24(4):828-838. doi: 10.1002/ejp.1533. Epub 2020 Jan 30.
PubMed 31955478
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Continuous Serratus Anterior Plane Blockade With Continuous Thoracic Paravertebral Blockade for Perioperative Analgesia Following Video-assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT03768193
- Acronym / sponsor ID
- SAPB / 1/378/1918
- Conditions
- Thoracic Diseases, Thoracic Surgery, Rib Fractures, Pain, Postoperative, Pain, Procedural, Anaesthesia, Regional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mater Misericordiae University HospitalUniversity, hospital or other
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 7 Dec 2018 (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.
Thoracic surgery, and surgery involving the chest wall in general, is associated with poorly controlled acute pain, which may result in delayed functional recovery, and may progress to chronic pain. Multimodal opioid-sparing analgesia regimens are a key component of the thoracic surgery enhanced recovery pathway, the aim of which is to improve outcomes in patients undergoing both minimally invasive and open thoracic surgical procedures. Novel interfascial plane blocks are emerging as feasible alternatives to central neuraxial analgesia techniques in a variety of clinical settings.
The aim of this study is to show non-inferiority of serratus anterior blockade compared with surgically placed paravertebral blocks in the management of perioperative acute pain in patients undergoing VATS procedures.
Detailed description
Post-thoracotomy pain syndrome is an unwanted complication of thoracic surgery. Poorly controlled pain may precipitate increased morbidity in the immediate and early postoperative periods due to its adverse effects on respiratory mechanics and mobilisation, which may result in further morbidity such as postoperative pulmonary complications and thrombosis. Poor perioperative management of this pain may also result in the development of chronic pain. Enhanced recovery, particularly functional recovery has become an important goal in the perioperative management of our patients. A key principle of this pathway is multimodal opioid-sparing analgesia to facilitate improved recovery and patient outcomes. Regional anaesthesia forms the cornerstone of this multimodal analgesia regimen.
Traditionally, thoracic epidural and thoracic paravertebral blockade have been the main forms of regional anaesthesia utilised in thoracic surgical patients undergoing lung resection. With the increasing use of minimally invasive thoracic surgery and with a cohort of patients who may not always be suitable for central neuraxial blockade, alternatives are needed. More recently, there has been an emerging use of interfascial plane blocks in this patient group. The interest in these techniques is derived from case reports, case series, cadaveric studies, and small clinical trials, which have demonstrated clinical efficacy in a variety of elective and emergency thoracic surgical procedures and also in chronic thoracic pain syndromes.
The deep serratus anterior plane (deep SAP) block is a relatively new interfascial plane regional anaesthesia technique, which has been postulated to provide analgesia of the entire hemithorax. The mechanism of its analgesic effects are believed to occur via blockade of the lateral cutaneous branches of the thoracic intercostal nerves (T2-T12), which produces analgesia of the anterolateral chest wall. A recent anatomical study by Mayes et al. demonstrated consistent blockade of the lateral cutaneous branches of the intercostal nerves. Clinical studies, although small, have shown dermatomal spread in the T2 - T9 distribution of the anterolateral chest wall. Therefore, this block presents a potential alternative to central neuraxial blockade.
However, whether SAP blockade can produce non-inferior analgesia compared with either thoracic epidural or thoracic paravertebral, both in terms of somatic +/- autonomic blockade, and the reliability of dermatomal spread, has been questioned by some.
The aim of this randomised controlled trial is to demonstrate non-inferiority of ultrasound-guided continuous deep serratus anterior plane blockade compared with surgically-placed continuous paravertebral blockade, for perioperative analgesia, in the patients undergoing minimally-invasive videoscopic thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep serratus anterior plane block | Experimental | Procedure: Deep serratus anterior plane blockUltrasound-guided deposition of 40mls of 2mg/ kg levobupivacaine into the deep serratus anterior plane space, in the mid axillary line, at the level of the 4th/5th rib. Insertion of a continuous local anaesthetic infusion catheter(Portex™) and continuation of an infusion of 0.125% levobupivacaine at a rate of 8-12mls/ hour for 48 hours. |
| Surgically-placed paravertebral block | Active comparator | Procedure: Surgically-placed paravertebral blockSurgical placement of paravertebral local anaesthetic infusion catheters (Portex™) prior to closure. Bolus of levobupivacaine as per protocol. Continuation of an infusion of 0.125% levobupivacaine at a rate of 8-12mls/ hour for 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults greater than or equal to 18 years of age presenting for minimally-invasive thoracic surgery.
Key exclusion criteria (10 listed)
- Patient refusal.
- Local infection at site of insertion.
- Allergy to amide local anaesthetics, opioids, paracetamol, NSAIDs, ketamine, NMBs, volatile anaesthetics.
- Concurrent use of antiarrhythmics with local anaesthetic activity.
- Concurrent use of MAOIs or within 2 weeks of MAOI use.
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 |
|---|---|---|
| Deep serratus anterior plane blockDeposition of local anaesthetic in the space between the serratus anterior muscle and the external intercostal muscle, at the level of the 4th-5th rib, in the midaxillary line. Procedure performed under ultrasound guidance. Catheter - based infusion of local anaesthetic into this space for 48 hours. | Procedure or surgery | Deep serratus anterior plane block |
| Surgically-placed paravertebral blockSurgically-placed paravertebral block catheters for continuous local anaesthetic infusion of 0.125% levobupivacaine at 8-12mls/ hr for 48 hours. | Procedure or surgery | Surgically-placed paravertebral block |
Primary outcome
Opioid consumption
Time frame: Over the first 48 hours postoperatively
Expressed as oral morphine equivalent
9 secondary outcomes
Postoperative numerical pain scores
Time frame: Over the first 48 hours postoperatively
Opioid side - effects - 1
Time frame: Over the first 48 hours postoperatively
Opioid side - effects - 2
Time frame: Over the first 48 hours postoperatively
Opioid side - effects - 3
Time frame: Over the first 48 hours postoperatively
Mean arterial blood pressure
Time frame: Over the first 48 hours postoperatively.
Presence of dermatomal sensory block distribution
Time frame: Within the first 24 hours postoperatively
Functional assessment
Time frame: Within the first 48 hours postoperatively
Patient satisfaction
Time frame: Over the first 48 hours postoperatively
Duration of inpatient hospital admission
Time frame: From date of admission for surgery to date of discharge by the thoracic team; through to study completion.
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 7 Dec 2018.
- Derived from this study: PubMed 31955478Hanley C, Wall T, Bukowska I, Redmond K, Eaton D, Ni Mhuircheartaigh R, Hearty C. Ultrasound-guided continuous deep serratus anterior plane block versus continuous thoracic paravertebral block for perioperative analgesia in videoscopic-assisted thoracic surgery. Eur J Pain. 2020 Apr;24(4):828-838. doi: 10.1002/ejp.1533. Epub 2020 Jan 30.
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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.
Conor Hearty, FFPMCAI,FFPMANZCA,FCARCSI,FIPP principal investigator
Consultant Anaesthetist, Mater Misericordiae University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep serratus anterior plane block and Surgically-placed paravertebral block in people with Thoracic Diseases and Thoracic Surgery, run by Mater Misericordiae University Hospital at 1 site in Ireland.
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 1 inclusion and 10 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 7 Dec 2018. 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 Ireland. 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. 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?
Opioid consumption (time frame: Over the first 48 hours postoperatively). 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 NCT03768193, 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 7 Dec 2018.