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)
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 hoursPatient 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).
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 04. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: March 4, 2024, Last downloaded: ClinicalTrials.gov processed this data on March 13, 2024, Last updated: March 13, 2024 |
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| PPN (Katalog-ID): |
CTG000069558 |
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| 245 | 1 | 0 | |a Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS) |b Analgesic Efficacy of Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in Video- Assisted Thoracoscopy (VATS) |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: March 4, 2024, Last downloaded: ClinicalTrials.gov processed this data on March 13, 2024, Last updated: March 13, 2024 | ||
| 520 | |a 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 hoursPatient 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) | ||
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Not yet recruiting | |
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