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

Primary Purpose

Pain, Acute, Surgery

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS
Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS
Sponsored by
Mater Misericordiae University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Regional Anesthesia, Erector Spinae Block, VATS, Quality of Recovery, Acute pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mater Misericordiae University Hospital
  • St Jame's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB)

Ultrasound Guided ESP Block with Continuous Infusion (CI)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 19, 2021
Last Updated
September 17, 2023
Sponsor
Mater Misericordiae University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05181371
Brief Title
ESP Block in VATS: Programmed Intermittent Bolus Versus Continuous Infusion on Quality of Recovery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Surgery
Keywords
Regional Anesthesia, Erector Spinae Block, VATS, Quality of Recovery, Acute pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ultrasound Guided ESP Block with Continuous Infusion (CI)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS
Intervention Description
Programmed Intermittent Bolus (PIB) of Levobupivacaine
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS
Intervention Description
Continuous Infusion (CI) of Levobupivacaine
Primary Outcome Measure Information:
Title
Quality of Recovery (QoR-15)
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Maximal inspiratory volume
Description
This will be measured with a calibrated incentive spirometer at the bedside
Time Frame
48 hours
Title
Area Under the Curve for Verbal Rating Score for pain at rest
Description
Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
Time Frame
48 hours
Title
Area Under the Curve for Verbal Rating Score for pain on deep inspiration
Description
Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
Time Frame
48 hours
Title
Time to first intravenous opioid
Description
Will be measured from immediate postoperative in minutes
Time Frame
48 hours
Title
Time to first mobilisation
Description
Will be measured from immediate postoperative in hours
Time Frame
48 hours
Title
Duration of time in PACU .
Description
Will be measured from immediate postoperative in minutes
Time Frame
24 hours
Title
Length of hospital stay
Description
Will be measured from immediate postoperative in days
Time Frame
30 days
Title
Quality of Recovery (QoR-15)
Description
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
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donal Buggy
Organizational Affiliation
Mater University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
D07 R2WY
Country
Ireland
Facility Name
St Jame's University Hospital
City
Dublin
ZIP/Postal Code
D08 NHy1
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33878196
Citation
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.
Results Reference
background
PubMed Identifier
32660716
Citation
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.
Results Reference
background
PubMed Identifier
28131113
Citation
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.
Results Reference
background
PubMed Identifier
30636717
Citation
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.
Results Reference
background
PubMed Identifier
36131308
Citation
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.
Results Reference
derived
Links:
URL
https://doi.org/10.21203/rs.3.rs-703831/v1
Description
ESP vs PVB

Learn more about this trial

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

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