ESP Block in VATS: Programmed Intermittent Bolus Versus Continuous Infusion on Quality of Recovery

NCT05181371 | Completed

• 1 other identifier: ESP2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient centred outcomes such as quality of recovery.

Conditions

Pain, Acute; Surgery

Keywords

Regional Anesthesia; Erector Spinae Block; VATS; Quality of Recovery; Acute pain

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery (QoR-15)

  Patient centred metric to measure the quality of recovery after surgery. Scale is between 0-150, where '0' refers to poor quality of recovery and '150' refers to excellent quality of recovery

  24 hours

Secondary Outcomes (8)

• Maximal inspiratory volume

  48 hours

• Area Under the Curve for Verbal Rating Score for pain at rest

  48 hours

• Area Under the Curve for Verbal Rating Score for pain on deep inspiration

  48 hours

• Time to first intravenous opioid

  48 hours

• Time to first mobilisation

  48 hours

Study Arms (2)

Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB)

ACTIVE COMPARATOR

After induction of general anaesthesia, an ESP catheter will be inserted at the level of T5. A bolus dose of 20 ml 0.25% Levobupicaine will be administered into the ESP space. Two hours post bolus administration, patients will receive programmed intermittent bolus of local anaesthetic: 20mls 0.125% levobupivacaine every two hours.

Procedure: Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS

Ultrasound Guided ESP Block with Continuous Infusion (CI)

ACTIVE COMPARATOR

After induction of general anaesthesia, an ESP catheter will be inserted at the level of T5. A bolus dose of 20 ml 0.25% Levobupicaine will be administered into the ESP space. Two hours post bolus administration, patients will receive a continuous infusion local anaesthetic: 0.125% levobupivacaine at an infusion rate of 10 ml/hr.

Procedure: Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS

Interventions

Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS PROCEDURE

Programmed Intermittent Bolus (PIB) of Levobupivacaine

Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB)

Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS PROCEDURE

Continuous Infusion (CI) of Levobupivacaine

Ultrasound Guided ESP Block with Continuous Infusion (CI)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female aged \> 18
• Able to provide written informed consent
• ASA grade I - V
• VATS surgery
• Weight \> 55kg

You may not qualify if:

• Absence of or inability to give informed consent
• Pre-existing infection at block site
• Severe coagulopathy
• Allergy to local anaesthesia (or another contraindication to block performance)
• Previous history of opiate abuse
• Pre-existing chronic pain condition
• Pre-existing dementia (due to need to co-operate in completing QoR-15 score day after surgery
• Postoperative admission to ICU for continued ventilation
• BMI \> 40 kg/m2

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead

Study Sites (2)

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

Location

St Jame's University Hospital

Dublin, D08 NHy1, Ireland

Location

Related Publications (5)

• Finnerty D, Ni Eochagain A, Ahmed M, Poynton A, Butler JS, Buggy DJ. A randomised trial of bilateral erector spinae plane block vs. no block for thoracolumbar decompressive spinal surgery. Anaesthesia. 2021 Nov;76(11):1499-1503. doi: 10.1111/anae.15488. Epub 2021 Apr 20.

  PMID: 33878196 BACKGROUND

• Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.

  PMID: 32660716 BACKGROUND

• Onuoha OC. Epidural Analgesia for Labor: Continuous Infusion Versus Programmed Intermittent Bolus. Anesthesiol Clin. 2017 Mar;35(1):1-14. doi: 10.1016/j.anclin.2016.09.003. Epub 2016 Dec 12.

  PMID: 28131113 BACKGROUND

• Ilfeld BM, Gabriel RA. Basal infusion versus intermittent boluses for perineural catheters: should we take the 'continuous' out of 'continuous peripheral nerve blocks'? Reg Anesth Pain Med. 2019 Mar;44(3):285-286. doi: 10.1136/rapm-2018-100262. Epub 2019 Jan 13. No abstract available.

  PMID: 30636717 BACKGROUND

• Eochagain AN, Moorthy A, O'Gara A, Buggy DJ. Ultrasound-guided, continuous erector spinae plane (ESP) block in minimally invasive thoracic surgery-comparing programmed intermittent bolus (PIB) vs continuous infusion on quality of recovery and postoperative respiratory function: a double-blinded randomised controlled trial. Trials. 2022 Sep 21;23(1):792. doi: 10.1186/s13063-022-06726-7.

  PMID: 36131308 DERIVED

Related Links

• ESP vs PVB

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donal Buggy

  Mater University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: January 6, 2022
• Study Start: June 2, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5 years
• Access Criteria: Publications, reports or query requests from future investigators.

Locations

IE (2)