CompletedPhase 3ACTRN12619000648123

Lignocaine versus Opioids in Coronary Intervention: Assessing Antiplatelet Activity and Ticagrelor Levels (LOCAL) study

Lignocaine versus opioids as analgesia in patients undergoing percutaneous coronary intervention and its pharmacokinetic and pharmacodynamic impacts on the antiplatelet activity of ticagrelor


Sponsor

Alfred Health

Enrollment

70 participants

Start Date

Feb 13, 2020

Study Type

Interventional

Conditions

Summary

This randomised study will evaluate the efficacy of intravenous lignocaine as an alternative analgesic in patients undergoing percutaneous coronary intervention to fentanyl which is standard of care. The rationale behind this study relates to multiple biochemical studies demonstrating delayed absorption of antiplatelet agents when opioid analgesia is administered. Furthermore, these studies demonstrate that by delaying gastric absorption, the antiplatelet effects of ticagrelor based on platelet function are also delayed. Retrospective analysis of large clinical studies suggest poorer clinical outcomes in patients treated wtih opioid analgesia. Patients admitted and consented for coronary angiography will be recruited from The Alfred Hospital, Victoria. Patients presenting with STEMI, cardiogenic shock, out of hospital cardiac arrest, previous opioid or P2Y12 administration, coagulopathy or allergy to opioids or lignocaine will be excluded. Patients undergoing percutaneous coronary intervention will be randomised to receive either lignocaine or fentanyl as follows: For patients allocated to lignocaine: - Lignocaine 1mg/kg (maximum dose 100mg) will be given as a bolus at the start of the case - During the case, if analgesia is required a further bolus of 0.5mg/kg will be given. - If satisfactory analgesia is not achieved then patient will crossover to fentanyl arm - Total lignocaine dose will be recorded For patients allocated to fentanyl: - If under 70 years of age 0.75mcg/kg of Fentanyl IV will be given at the start of the case. If >70 years of age 0.5mcg/kg will be given at the start of the case. - Further IV fentanyl boluses can be given at the discretion of the interventional cardiologist if further analgesia is required during the case - Fentanyl IV 0.5mcg/kg mcg will be given at the end of the case at the time of administration of ticagrelor. Study endpoints will evaluate the efficacy of intravenous lignocaine in terms of analgesic efficacy and assess the interaction in terms of platelet function studies and pharmacokinetic analysis. This will determine if lignocaine is a safe, effective alternative analgesic which does not interact with antiplatelet agents.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Males and non-pregnant females over 18 years of age who have provided informed consent for angiography and PCI

Exclusion Criteria8

  • Out of hospital cardiac arrest
  • STEMI
  • Cardiogenic shock
  • Morphine or opiate administration in the preceding 24 hours or regular use
  • Patients with a known coagulopathy or coagulation disorder
  • Allergy to fentanyl or lignocaine
  • Bradycardia or evidence of AV block
  • Ticagrelor or other P2Y12 inhibitor use in the preceding 10 days

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Interventions

Randomised controlled trial comparing intravenous lignocaine to intravenous fentanyl in patients requiring periprocedural analgesia for percutaneous coronary intervention to evaluate pharmacokinetic a

Randomised controlled trial comparing intravenous lignocaine to intravenous fentanyl in patients requiring periprocedural analgesia for percutaneous coronary intervention to evaluate pharmacokinetic and pharmacodynamic impact on ticagrelor. The angiogram and coronary stent insertion procedure typically lasts 1-1.5 hours. The intervention will be administered by cath lab nursing staff. Treatment arm: - Lignocaine 1mg/kg (maximum dose 100mg) will be given as a intravenous (IV) bolus at the start of the angiogram procedure after time-out is completed - During the case, if analgesia is required a further bolus of 0.5mg/kg IV will be given at least 15 minutes after previous dose. - If satisfactory analgesia is not achieved then patient will crossover to fentanyl arm - Total lignocaine dose will be recorded Ticagrelor will be given as a 180mg oral tablet loading dose with 250ml of water at the end of the coronary stent procedure in both arms.


Locations(1)

The Alfred - Prahran

VIC, Australia

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ACTRN12619000648123


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