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Clinical trial

Intravenous Lignocaine as an Analgesic Adjunct in Adolescent Idiopathic Scoliosis Surgery (IGNITE-AIS Study)

ID
Name
UM.M/PDR/638/3(151)
Description
This is a single-center study comparing the effect of intravenous (IV) Lignocaine given throughout posterior spinal fusion surgery on the reduction of morphine usage during postoperative period in adolescent idiopathic scoliosis (AIS) patients.
Trial arms
Trial start
2020-12-24
Estimated PCD
2022-03-31
Trial end
2022-09-30
Status
Completed
Phase
Early phase I
Treatment
Lignocaine
Group A will receive 1.5mg/kg IV lignocaine bolus prior to induction followed by 2mg/kg/hour of lignocaine infusion throughout surgery until wound closure in which the infusion will be halved to 1mg/kg/hour until the end of surgery. The same rate will be infused in the recovery room for another half an hour before participant is discharge.
Arms:
Lignocaine
Other names:
Group A
Normal saline
Group B will receive saline of similar volume and rate as Group A
Arms:
Placebo
Other names:
Group B
Size
115
Primary endpoint
To evaluate postoperative morphine consumption at 24 hours
Immediately post-operation until 24 hours post-operation
Eligibility criteria
Inclusion Criteria: * American Society of Anaesthesiologists (ASA) physical status I and II Exclusion Criteria: * Hypersensitivity to amide local anaesthetics/lignocaine * Liver disease (alanine aminotransferase, ALT or aspartate aminotransferase, AST more than twice normal) * Renal impairment (defined as estimated Glomerular Filtration Rate \<= 60ml/min) * History of cardiac disease/cardiac arrhythmia * Epilepsy * Intellectual disability * Preoperative chronic pain with regular opioid usage
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A, Lignocaine and Group B, placebo. Group A will receive 1.5 mg/kg IV lignocaine bolus prior to induction followed by 2mg/kg/hour of lignocaine infusion throughout surgery until wound closure in which the infusion rate will be halved to 1 mg/kg/hour until the end of surgery. This same rate will be infused in the recovery room for another half an hour before patient discharge. Group B will receive saline of similar volume and rate as for Group A.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The medications will be prepared before induction by a nurse or doctor who is neither a member of the trial team and later handed to the anaesthetist in charge of the administration according to the trial protocol. The trial drugs are prepared in a 10-ml syringe for the bolus injection and a 50-ml syringe for continuous infusion. For the bolus injection, IV lignocaine 1% will be drawn into the 10-ml syringe will lignocaine 1% solution according to the weight of the patient (0.15ml/kg) or an equal amount of 0.9% saline. The 50-ml syringe contained either 50ml of lignocaine 1% solution or 0.9% normal saline solution.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 115, 'type': 'ACTUAL'}}
Updated at
2024-06-07

1 organization

1 product

1 drug

2 indications

Organization
University of Malaya
Product
Lignocaine
Indication
Adolescent Idiopathic Scoliosis
Indication
Analgesic
Drug
Varlilumab