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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181371
• Other study ID #: ESP2
• Status: Completed
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: Mater Misericordiae University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Surgery

Intervention

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

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St Jame's University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Mater Misericordiae University Hospital

Country where clinical trial is conducted

Ireland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery (QoR-15)	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	24 hours
Secondary	Maximal inspiratory volume	This will be measured with a calibrated incentive spirometer at the bedside	48 hours
Secondary	Area Under the Curve for Verbal Rating Score for pain at rest	Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.	48 hours
Secondary	Area Under the Curve for Verbal Rating Score for pain on deep inspiration	Pain scores (0-10). '0' refers to no pain and '10' refers to severe pain.	48 hours
Secondary	Time to first intravenous opioid	Will be measured from immediate postoperative in minutes	48 hours
Secondary	Time to first mobilisation	Will be measured from immediate postoperative in hours	48 hours
Secondary	Duration of time in PACU .	Will be measured from immediate postoperative in minutes	24 hours
Secondary	Length of hospital stay	Will be measured from immediate postoperative in days	30 days
Secondary	Quality of Recovery (QoR-15)	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	48 hours

External Links

•   ESP vs PVB