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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05181371
Enrollment
60
Registered
2022-01-06
Start date
2022-06-02
Completion date
2023-08-01
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute, Surgery

Keywords

Regional Anesthesia, Erector Spinae Block, VATS, Quality of Recovery, Acute pain

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.

Interventions

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

Programmed Intermittent Bolus (PIB) of Levobupivacaine

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

Continuous Infusion (CI) of Levobupivacaine

Sponsors

Mater Misericordiae University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery (QoR-15)24 hoursPatient 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

MeasureTime frameDescription
Area Under the Curve for Verbal Rating Score for pain at rest48 hoursPain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
Area Under the Curve for Verbal Rating Score for pain on deep inspiration48 hoursPain scores (0-10). '0' refers to no pain and '10' refers to severe pain.
Time to first intravenous opioid48 hoursWill be measured from immediate postoperative in minutes
Maximal inspiratory volume48 hoursThis will be measured with a calibrated incentive spirometer at the bedside
Duration of time in PACU .24 hoursWill be measured from immediate postoperative in minutes
Length of hospital stay30 daysWill be measured from immediate postoperative in days
Quality of Recovery (QoR-15)48 hoursPatient 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
Time to first mobilisation48 hoursWill be measured from immediate postoperative in hours

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026