Thoracic Surgery, Video-Assisted
Conditions
Keywords
esp block, lignocaine, Thoracic Surgery, Video-Assisted, erector spinae block
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)
Interventions
PROCEDUREErector Spinae Plane (ESP) block
Erector Spinae Plane (ESP) block with bupivacaine and for pain management in VATS procedure
DRUGLignocaine
Lignocaine bolus and infusion for pain management in VATS procedure
DRUGBupivacaine
Bupivicaine with adrenaline will be used to perform the ESP block
Sponsors
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patient and nursing staff will be blinded to the performed intervention. PI and performing anaesthesiologist will not be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 * VATS for tumor resection or partial lung resection in emphysema * Written, informed consent obtained 1 day prior to surgery
Exclusion criteria
* Lack of consent for ESP blockade * History of allergy to local anaesthetics * Other contraindications to ESP blockade * American Society of Anesthesiologists(ASA) Physical Status Classification value 4 or higher * VATS for indications other than tumor resection or partial lung resection in emphysema * Insulin- dependent diabetes mellitus * More than 1 chest drain post-operatively * Conversion to thoracotomy * Chronic opioid use prior to surgery defined as opioid administration for at least 3 months during the last 12 months * History of alcohol abuse * Suspected technical difficulties with performing the ESP block (e.g. obesity) * Inadequate spread of the local anaesthetic during the ESP block * Cognitive impairment that might cause an inaccurate assessment of pain levels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORAntoni Okniński, MD
National Medical Institute of the Ministry of the Interior and Administration
Outcome results
None listed