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Deep Serratus Anterior Plane Block vs Surgically-placed Paravertebral Block for VATS Surgery (SAPB)

Primary Purpose

Thoracic Diseases, Thoracic Surgery, Rib Fractures

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Deep serratus anterior plane block
Surgically-placed paravertebral block
Sponsored by
Mater Misericordiae University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• All adults greater than or equal to 18 years of age presenting for minimally-invasive thoracic surgery.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Mater Misericordiae University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deep serratus anterior plane block

Surgically-placed paravertebral block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Opioid consumption
Expressed as oral morphine equivalent

Secondary Outcome Measures

Postoperative numerical pain scores
Numerical rating scale. 0 - 10. 0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain.
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.
Opioid side - effects - 2
Nausea/ vomiting scale. Questionnaire. 0= none, 1=mild, 2=moderate, 3=severe
Opioid side - effects - 3
Itch/ Pruritis scale 0= none, 1=mild, 2=moderate, 3=severe
Mean arterial blood pressure
Calculated from systolic and diastolic blood pressure.
Presence of dermatomal sensory block distribution
Dermatomal sensory block distribution
Functional assessment
Walking distance in meters assessed by physiotherapist
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.
Duration of inpatient hospital admission
Measured in days.

Full Information

First Posted
September 27, 2018
Last Updated
December 5, 2018
Sponsor
Mater Misericordiae University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03768193
Brief Title
Deep Serratus Anterior Plane Block vs Surgically-placed Paravertebral Block for VATS Surgery
Acronym
SAPB
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mater Misericordiae University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases, Thoracic Surgery, Rib Fractures, Pain, Postoperative, Pain, Procedural, Anaesthesia, Regional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep serratus anterior plane block
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgically-placed paravertebral block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Deep serratus anterior plane block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgically-placed paravertebral block
Intervention Description
Surgically-placed paravertebral block catheters for continuous local anaesthetic infusion of 0.125% levobupivacaine at 8-12mls/ hr for 48 hours.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Expressed as oral morphine equivalent
Time Frame
Over the first 48 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative numerical pain scores
Description
Numerical rating scale. 0 - 10. 0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain.
Time Frame
Over the first 48 hours postoperatively
Title
Opioid side - effects - 1
Description
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.
Time Frame
Over the first 48 hours postoperatively
Title
Opioid side - effects - 2
Description
Nausea/ vomiting scale. Questionnaire. 0= none, 1=mild, 2=moderate, 3=severe
Time Frame
Over the first 48 hours postoperatively
Title
Opioid side - effects - 3
Description
Itch/ Pruritis scale 0= none, 1=mild, 2=moderate, 3=severe
Time Frame
Over the first 48 hours postoperatively
Title
Mean arterial blood pressure
Description
Calculated from systolic and diastolic blood pressure.
Time Frame
Over the first 48 hours postoperatively.
Title
Presence of dermatomal sensory block distribution
Description
Dermatomal sensory block distribution
Time Frame
Within the first 24 hours postoperatively
Title
Functional assessment
Description
Walking distance in meters assessed by physiotherapist
Time Frame
Within the first 48 hours postoperatively
Title
Patient satisfaction
Description
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.
Time Frame
Over the first 48 hours postoperatively
Title
Duration of inpatient hospital admission
Description
Measured in days.
Time Frame
From date of admission for surgery to date of discharge by the thoracic team; through to study completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • All adults greater than or equal to 18 years of age presenting for minimally-invasive thoracic surgery. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conor Hearty, FFPMCAI,FFPMANZCA,FCARCSI,FIPP
Organizational Affiliation
Consultant Anaesthetist, Mater Misericordiae University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31955478
Citation
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.
Results Reference
derived

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Deep Serratus Anterior Plane Block vs Surgically-placed Paravertebral Block for VATS Surgery

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