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

September 17, 2023 updated by: Aneurin Moorthy, Mater Misericordiae University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Minimally invasive thoracic surgery (MITS) has been shown to reduce postoperative pain, reduce tissue trauma and contribute to better recovery as compared to open thoracotomy. However, it still causes significant acute post-operative pain. Our Mater research group has shown that fascial plane blocks such as the Erector Spinae Plane block (ESP) contribute to post-operative analgesia after MITS. Case reports have described the improved quality of analgesia following ESP using programmed intermittent boluses (PIB) instead of continuous infusion. It is hypothesised that larger, repeated bolus doses provide superior analgesia, possibly as a result of improved spread of the local anaesthetic. Evidence for improved spread of local anaesthetic may be found in one study which demonstrated that PIB increased the number of affected dermatomal levels compared to continuous infusions for continuous paravertebral blocks. Similarly, with regard to labour epidural analgesia, PIB provides better analgesia compared with continuous infusion.

Because 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 the 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-centered outcomes such as quality of recovery.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D07 R2WY
        • Mater Misericordiae University Hospital
      • Dublin, Ireland, D08 NHy1
        • St Jame's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB)
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
Programmed Intermittent Bolus (PIB) of Levobupivacaine
Active Comparator: Ultrasound Guided ESP Block with Continuous Infusion (CI)
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
Continuous Infusion (CI) of Levobupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery (QoR-15)
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal inspiratory volume
Time Frame: 48 hours
This will be measured with a calibrated incentive spirometer at the bedside
48 hours
Area Under the Curve for Verbal Rating Score for pain at rest
Time Frame: 48 hours
Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
48 hours
Area Under the Curve for Verbal Rating Score for pain on deep inspiration
Time Frame: 48 hours
Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
48 hours
Time to first intravenous opioid
Time Frame: 48 hours
Will be measured from immediate postoperative in minutes
48 hours
Time to first mobilisation
Time Frame: 48 hours
Will be measured from immediate postoperative in hours
48 hours
Duration of time in PACU .
Time Frame: 24 hours
Will be measured from immediate postoperative in minutes
24 hours
Length of hospital stay
Time Frame: 30 days
Will be measured from immediate postoperative in days
30 days
Quality of Recovery (QoR-15)
Time Frame: 48 hours
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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mater Misericordiae University Hospital

Investigators

  • Principal Investigator: Donal Buggy, Mater University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

December 19, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESP2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual Patient Data sharing will be supported with qualified external researchers and supporting clinical documents from eligible studies. All data provided will be coded and anonymised to respect the privacy of patients who have participated in the trial.

IPD Sharing Time Frame

5 years

IPD Sharing Access Criteria

Publications, reports or query requests from future investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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