ESP Block in VATS: Programmed Intermittent Bolus Versus Continuous Infusion on Quality of Recovery
- Conditions
- Pain, AcuteSurgery
- Interventions
- Procedure: Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATSProcedure: Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS
- Registration Number
- NCT05181371
- Lead Sponsor
- Mater Misericordiae University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Male and Female aged > 18
- Able to provide written informed consent
- ASA grade I - V
- VATS surgery
- Weight > 55kg
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound Guided ESP Block with Continuous Infusion (CI) Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS 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. Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS 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.
- Primary Outcome Measures
Name Time Method Quality of Recovery (QoR-15) 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 Outcome Measures
Name Time Method Maximal inspiratory volume 48 hours This will be measured with a calibrated incentive spirometer at the bedside
Area Under the Curve for Verbal Rating Score for pain on deep inspiration 48 hours Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
Length of hospital stay 30 days Will be measured from immediate postoperative in days
Quality of Recovery (QoR-15) 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
Area Under the Curve for Verbal Rating Score for pain at rest 48 hours Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
Time to first intravenous opioid 48 hours Will be measured from immediate postoperative in minutes
Time to first mobilisation 48 hours Will be measured from immediate postoperative in hours
Duration of time in PACU . 24 hours Will be measured from immediate postoperative in minutes
Trial Locations
- Locations (2)
St Jame's University Hospital
🇮🇪Dublin, Ireland
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland