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

M

Mater Misericordiae University Hospital

Status

Completed

Conditions

Surgery
Pain, Acute

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB)
Active Comparator group
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.
Treatment:
Procedure: Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS
Ultrasound Guided ESP Block with Continuous Infusion (CI)
Active Comparator group
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.
Treatment:
Procedure: Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS

Trial contacts and locations

2

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Central trial contact

Donal Buggy

Data sourced from clinicaltrials.gov

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