Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289790
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-19
Brief Title:
Erector Spinae Plane ESP Block vs Intravenous Lignocaine Infusion in VATS
Sponsor:
Central Clinical Hospital of the Ministry of Internal Affairs and Administration Warsaw Poland
Organization:
Central Clinical Hospital of the Ministry of Internal Affairs and Administration Warsaw Poland
Study Overview
Official Title:
Analgesic Efficacy of Erector Spinae Plane ESP Block vs Intravenous Lignocaine Infusion in Video- Assisted Thoracoscopy VATS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 EnvelopeTM12 will be used to randomly and evenly assign patients to one of the two groups Blocks of 468 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 ultrasoundUSG guided ESP blockade at Th5 single shot of 30 ml 03 bupivacaine not exceeding the maximum dose of 2 mgkg of bupivacaine with adrenaline 5 µgml and dexamethasone 015 mgkg intravenously post-operative infusion of 09 NaCl for 6 hours infusion rate set as if it were lignocaine 15 mgkgh vs pre-induction lignocaine bolus of 15 mgkg iv and dexamethasone 015 mgkg intravenously intraoperative infusion of lignocaine 2 mgkg iv post-operative infusion of lignocaine 15 mgkg iv 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 13612 hours after surgery and on discharge from post- anaesthesia care unit PACUafter 24 hours- whichever comes sooner 2 cumulative opioid dose after 12 hours and on discharge from PACUafter 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 surgeryBP measured at 13612 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
Randomization An online tool Sealed EnvelopeTM12 will be used to randomly and evenly assign patients to one of the two groups Blocks of 468 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 ultrasoundUSG guided ESP blockade at Th5 single shot of 30 ml 03 bupivacaine not exceeding the maximum dose of 2 mgkg of bupivacaine with adrenaline 5 µgml and dexamethasone 015 mgkg intravenously post-operative infusion of 09 NaCl for 6 hours infusion rate set as if it were lignocaine 15 mgkgh vs pre-induction lignocaine bolus of 15 mgkg iv and dexamethasone 015 mgkg intravenously intraoperative infusion of lignocaine 2 mgkg iv post-operative infusion of lignocaine 15 mgkg iv 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 13612 hours after surgery and on discharge from post- anaesthesia care unit PACUafter 24 hours- whichever comes sooner 2 cumulative opioid dose after 12 hours and on discharge from PACUafter 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 surgeryBP measured at 13612 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None