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

Pain, Postoperative Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768193
• Other study ID #: 1/378/1918
• Status: Completed
• Phase: N/A
• Start date: October 4, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: December 2018
• Source: Mater Misericordiae University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaesthesia, Regional
• Pain, Postoperative
• Pain, Procedural
• Rib Fractures
• Thoracic Diseases
• Thoracic Surgery

Intervention

Procedure:
• Deep serratus anterior plane block
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 block
Surgically-placed paravertebral block catheters for continuous local anaesthetic infusion of 0.125% levobupivacaine at 8-12mls/ hr for 48 hours.

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Mater Misericordiae University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Expressed as oral morphine equivalent	Over the first 48 hours postoperatively
Secondary	Postoperative numerical pain scores	Numerical rating scale. 0 - 10. 0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain.	Over the first 48 hours postoperatively
Secondary	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.	Over the first 48 hours postoperatively
Secondary	Opioid side - effects - 2	Nausea/ vomiting scale. Questionnaire. 0= none, 1=mild, 2=moderate, 3=severe	Over the first 48 hours postoperatively
Secondary	Opioid side - effects - 3	Itch/ Pruritis scale 0= none, 1=mild, 2=moderate, 3=severe	Over the first 48 hours postoperatively
Secondary	Mean arterial blood pressure	Calculated from systolic and diastolic blood pressure.	Over the first 48 hours postoperatively.
Secondary	Presence of dermatomal sensory block distribution	Dermatomal sensory block distribution	Within the first 24 hours postoperatively
Secondary	Functional assessment	Walking distance in meters assessed by physiotherapist	Within the first 48 hours postoperatively
Secondary	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.	Over the first 48 hours postoperatively
Secondary	Duration of inpatient hospital admission	Measured in days.	From date of admission for surgery to date of discharge by the thoracic team; through to study completion.