Clinical trial NCT06289790: Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS)
Official title: Analgesic Efficacy of Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in Video- Assisted Thoracoscopy (VATS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Surgery, Video-Assisted
Keywords: esp block
lignocaine
Thoracic Surgery, Video-Assisted
erector spinae block
Lead sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare analgesic efficacy of erector spinae plane (ESP) block vs intravenous lignocaine infusion in video- assisted thoracoscopy (VATS. The main goals are to compare post- operative pain scores and cumulative post- operative opioid doses in both groups

Detailed description: Number of patients: 60 patients enrolled for VATS procedure randomly and evenly assigned to one of the 2 groups.

Randomization: An online tool (Sealed EnvelopeTM\[12\]) will be used to randomly and evenly assign patients to one of the two groups. Blocks of 4,6,8 will be used and since the blocks assignment will be random as well, the total number of patients can be slightly larger than 60. On the day of the procedure an envelope containing one block of numbers will be opened and numbers from that envelope will be drawn for consecutive patients until the block is finished.

Intervention:

under general anaesthesia, preoperative ultrasound(USG) guided ESP blockade at Th5, single shot of 30 ml 0,3 % bupivacaine (not exceeding the maximum dose of 2 mg/kg of bupivacaine) with adrenaline 5 µg/ml and dexamethasone 0,15 mg/kg intravenously, post-operative infusion of 0,9% NaCl for 6 hours, infusion rate set as if it were lignocaine 1,5 mg/kg/h vs pre-induction lignocaine bolus of 1,5 mg/kg i.v. and dexamethasone 0,15 mg/kg intravenously, intraoperative infusion of lignocaine 2 mg/kg i.v., post-operative infusion of lignocaine 1,5 mg/kg i.v. for 6 hours

Patient and nursing staff will be blinded to the performed intervention.

Primary end- points: 1) pain score (static and dynamic defined as cough effort) on numerical rating score (NRS) 1,3,6,12 hours after surgery (and on discharge from post- anaesthesia care unit \[PACU\]/after 24 hours- whichever comes sooner) 2) cumulative opioid dose after 12 hours (and on discharge from PACU/after 24 hours- whichever comes sooner)

Secondary end- points: 1) incidence of adverse effects such as: severe hypotension (defined as a 20% drop of either mean arterial pressure (MAP), systolic blood pressure (SBP) or diastolic blood pressure (DBP) compared to baseline measured in the ward prior to surgery)\[BP measured at 1,3,6,12 hour and on discharge from PACU or more frequently if needed), nausea and vomiting, priuritis, local anaesthetic systemic toxicity symptoms.

2) intra- operative cumulative opioid dose 3) time to discharge from hospital (max. observation time: 30 days)

Eligibility criteria: Inclusion criteria:

* Age \>18
* VATS for tumor resection or partial lung resection in emphysema
* Written, informed consent obtained 1 day prior to surgery

Exclusion criteria:

* Lack of consent for ESP blockade
* History of allergy to local anaesthetics
* Other contraindications to ESP blockade
* American Society of Anesthesiologists(ASA) Physical Status Classification value 4 or higher
* VATS for indications other than tumor resection or partial lung resection in emphysema
* Insulin- dependent diabetes mellitus
* More than 1 chest drain post-operatively
* Conversion to thoracotomy
* Chronic opioid use prior to surgery defined as opioid administration for at least 3 months during the last 12 months
* History of alcohol abuse
* Suspected technical difficulties with performing the ESP block (e.g. obesity)
* Inadequate spread of the local anaesthetic during the ESP block
* Cognitive impairment that might cause an inaccurate assessment of pain levels

Primary outcomes:
measure: pain score on numerical rating score
timeFrame: 1,3,6,12 hours after surgery (and on discharge from post- anaesthesia care unit [PACU]/after 24 hours- whichever comes sooner)
measure: cumulative opioid dose
timeFrame: 12 hours after the end of the surgery (and on discharge from PACU/after 24 hours- whichever comes sooner)
Secondary outcomes:
measure: incidence of severe hypotension
timeFrame: BP measured at 1,3,6,12 hour and on discharge from PACU or more frequently if needed
measure: incidence of nausea and vomiting
timeFrame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
measure: incidence of priuritis
timeFrame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
measure: incidence of local anaesthetic systemic toxicity symptoms
timeFrame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
measure: intra-operative cumulative opioid dose
timeFrame: intra-operative
measure: time to discharge from hospital
timeFrame: max. observation time: 30 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: National Medical Institute of the Ministry of the Interior and Administration
state: Mazowieckie
Study officials:
affiliation: National Medical Institute of the Ministry of the Interior and Administration
name: Antoni Okniński, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
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