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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2023-08-01

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.

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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.

Conditions

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Pain, Acute Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Programmed Intermittent Bolus (PIB) of Levobupivacaine

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Continuous Infusion (CI) of Levobupivacaine

Interventions

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

Programmed Intermittent Bolus (PIB) of Levobupivacaine

Intervention Type PROCEDURE

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

Continuous Infusion (CI) of Levobupivacaine

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No