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

NCT03768193 | Completed

• 1 other identifier: 1/378/1918
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Expressed as oral morphine equivalent

  Over the first 48 hours postoperatively

Secondary Outcomes (9)

• Postoperative numerical pain scores

  Over the first 48 hours postoperatively

• Opioid side - effects - 1

  Over the first 48 hours postoperatively

• Opioid side - effects - 2

  Over the first 48 hours postoperatively

• Opioid side - effects - 3

  Over the first 48 hours postoperatively

• Mean arterial blood pressure

  Over the first 48 hours postoperatively.

Study Arms (2)

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.

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.

Procedure: Surgically-placed paravertebral block

Interventions

Deep serratus anterior plane block PROCEDURE

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.

Deep serratus anterior plane block

Surgically-placed paravertebral block PROCEDURE

Surgically-placed paravertebral block catheters for continuous local anaesthetic infusion of 0.125% levobupivacaine at 8-12mls/ hr for 48 hours.

Surgically-placed paravertebral block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Dublin 7, Ireland

Location

Related Publications (1)

• 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.

  PMID: 31955478 DERIVED

MeSH Terms

Conditions

Thoracic Diseases; Rib Fractures; Pain, Postoperative; Pain, Procedural

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Conor Hearty, FFPMCAI,FFPMANZCA,FCARCSI,FIPP

  Consultant Anaesthetist, Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: December 7, 2018
• Study Start: October 4, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

IE (1)