Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS)
- Conditions
- Thoracic Surgery, Video-Assisted
- Interventions
- Procedure: Erector Spinae Plane (ESP) block
- Registration Number
- NCT06289790
- Lead Sponsor
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
- 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)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESP block group Erector Spinae Plane (ESP) block 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 Lignocaine infusion group Lignocaine 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
- Primary Outcome Measures
Name Time Method pain score on numerical rating score 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)
cumulative opioid dose 12 hours after the end of the surgery (and on discharge from PACU/after 24 hours- whichever comes sooner) measured as fentanyl equivalent
- Secondary Outcome Measures
Name Time Method time to discharge from hospital max. observation time: 30 days measured as number of days in the hospital counting from the day of the surgery
incidence of severe hypotension 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
incidence of nausea and vomiting 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
incidence of priuritis 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
incidence of local anaesthetic systemic toxicity symptoms 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.
intra-operative cumulative opioid dose intra-operative measured as fentanyl equivalent
Trial Locations
- Locations (1)
National Medical Institute of the Ministry of the Interior and Administration
🇵🇱Warsaw, Mazowieckie, Poland