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Completed

NCT Number: NCT05181371

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

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mater Misericordiae University Hospital, Dublin, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Programmed Intermittent Bolus (PIB) of Levobupivacaine

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

Procedure

Continuous Infusion (CI) of Levobupivacaine

Primary outcomes

  1. 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

Secondary outcomes

  1. Maximal inspiratory volume

    Time frame: 48 hours

    This will be measured with a calibrated incentive spirometer at the bedside

  2. 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.

  3. 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.

  4. Time to first intravenous opioid

    Time frame: 48 hours

    Will be measured from immediate postoperative in minutes

  5. Time to first mobilisation

    Time frame: 48 hours

    Will be measured from immediate postoperative in hours

  6. Duration of time in PACU .

    Time frame: 24 hours

    Will be measured from immediate postoperative in minutes

  7. Length of hospital stay

    Time frame: 30 days

    Will be measured from immediate postoperative in days

  8. 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

Sponsors and collaborators

Lead sponsor

Mater Misericordiae University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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