Clinical trial
Analgesic Efficacy of Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in Video- Assisted Thoracoscopy (VATS)
Name
16/BW/2023'
Description
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
Trial arms
Trial start
2024-02-26
Estimated PCD
2024-11-07
Trial end
2024-11-07
Status
Not yet recruiting
Treatment
Erector Spinae Plane (ESP) block
Erector Spinae Plane (ESP) block for pain management in VATS procedure
Arms:
ESP block group
Other names:
ESP blockade
Lignocaine
Lignocaine bolus and infusion for pain management in VATS procedure
Arms:
Lignocaine infusion group
Other names:
Lignocaine infusion
Size
60
Primary endpoint
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)
cumulative opioid dose
12 hours after the end of the surgery (and on discharge from PACU/after 24 hours- whichever comes sooner)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patient and nursing staff will be blinded to the performed intervention. PI and performing anaesthesiologist will not be blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-03-04
1 organization
1 product
2 indications
Product
LignocaineIndication
Thoracic Surgical ProceduresIndication
Video-Assisted