NCT06289790

Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS)

Analgesic Efficacy of Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in Video- Assisted Thoracoscopy (VATS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Thoracic Surgery, Video-Assisted

Interventions

Type	Name	Description
PROCEDURE	Erector Spinae Plane (ESP) block	Erector Spinae Plane (ESP) block with bupivacaine and for pain management in VATS procedure
DRUG	Lignocaine	Lignocaine bolus and infusion for pain management in VATS procedure
DRUG	Bupivacaine	Bupivicaine with adrenaline will be used to perform the ESP block

Timeline

• Start date: 2024-04-11
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2024-03-04
• Last updated: 2026-01-21

Locations

1 site across 1 country: Poland