National Medical Institute of the Ministry of the Interior and Administration
Warsaw, Masovian Voivodeship, 02-507, Poland
NCT Number: NCT06289790
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Warsaw, Masovian Voivodeship, 02-507, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Erector Spinae Plane (ESP) block with bupivacaine and for pain management in VATS procedure
Other names: ESP blockade
Lignocaine bolus and infusion for pain management in VATS procedure
Other names: Lignocaine infusion
Bupivicaine with adrenaline will be used to perform the ESP block
Time frame: 1,3,6,12 hours after surgery (and on discharge from post- anaesthesia care unit [PACU]/after 24 hours- whichever comes sooner)
static and dynamic score (defined as cough effort) on numerical rating score (values: 0-10 where the lower number means less pain and a better outcome)
Time frame: 12 hours after the end of the surgery (and on discharge from PACU/after 24 hours- whichever comes sooner)
measured as fentanyl equivalent
Time frame: BP measured at 1,3,6,12 hour and on discharge from PACU or more frequently if needed
(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
Time frame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
patients will be monitored for incidence of nausea and vomiting and incidence of those will be noted
Time frame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
patients will be monitored for incidence of priuritis and incidence of it will be noted
Time frame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
Patients will be monitored for the following symptoms: limbs numbness, tinnitus, seizures, coma, bradycardia (defined as heart rate below 45 beats per minute), severe ventrical arrhytmias. Incidence of those will be noted.
Time frame: intra-operative
measured as fentanyl equivalent
Time frame: max. observation time: 30 days
measured as number of days in the hospital counting from the day of the surgery
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Other
Analgesic Efficacy of Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in Video- Assisted Thoracoscopy (VATS)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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