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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Acute, Surgery

Intervention / Treatment
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* Procedure: Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS
* Procedure: Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal inspiratory volume | 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 | 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 | Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain. | 48 hours | 
| Time to first intravenous opioid | Will be measured from immediate postoperative in minutes | 48 hours | 
| Time to first mobilisation | Will be measured from immediate postoperative in hours | 48 hours | 
| Duration of time in PACU . | Will be measured from immediate postoperative in minutes | 24 hours | 
| Length of hospital stay | Will be measured from immediate postoperative in days | 30 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 | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional Anesthesia, Erector Spinae Block, VATS, Quality of Recovery, Acute pain