Clinical trial NCT05181371: ESP Block in VATS: Programmed Intermittent Bolus Versus Continuous Infusion on Quality of Recovery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Surgery
Keywords: Regional Anesthesia
Erector Spinae Block
VATS
Quality of Recovery
Acute pain
Lead sponsor: Mater Misericordiae University Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery (QoR-15)
timeFrame: 24 hours
Secondary outcomes:
measure: Maximal inspiratory volume
timeFrame: 48 hours
measure: Area Under the Curve for Verbal Rating Score for pain at rest
timeFrame: 48 hours
measure: Area Under the Curve for Verbal Rating Score for pain on deep inspiration
timeFrame: 48 hours
measure: Time to first intravenous opioid
timeFrame: 48 hours
measure: Time to first mobilisation
timeFrame: 48 hours
measure: Duration of time in PACU .
timeFrame: 24 hours
measure: Length of hospital stay
timeFrame: 30 days
measure: Quality of Recovery (QoR-15)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St Jame's University Hospital
Study officials:
affiliation: Mater University Hospital
name: Donal Buggy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finnerty D, Ni Eochagain A, Ahmed M, Poynton A, Butler JS, Buggy DJ. A randomised trial of bilateral erector spinae plane block vs. no block for thoracolumbar decompressive spinal surgery. Anaesthesia. 2021 Nov;76(11):1499-1503. doi: 10.1111/anae.15488. Epub 2021 Apr 20.
citation: Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11.
citation: Onuoha OC. Epidural Analgesia for Labor: Continuous Infusion Versus Programmed Intermittent Bolus. Anesthesiol Clin. 2017 Mar;35(1):1-14. doi: 10.1016/j.anclin.2016.09.003. Epub 2016 Dec 12.
citation: Ilfeld BM, Gabriel RA. Basal infusion versus intermittent boluses for perineural catheters: should we take the 'continuous' out of 'continuous peripheral nerve blocks'? Reg Anesth Pain Med. 2019 Mar;44(3):285-286. doi: 10.1136/rapm-2018-100262. Epub 2019 Jan 13. No abstract available.
citation: Eochagain AN, Moorthy A, O'Gara A, Buggy DJ. 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: a double-blinded randomised controlled trial. Trials. 2022 Sep 21;23(1):792. doi: 10.1186/s13063-022-06726-7.