A Prospective Randomized Double Blind Study Comparing Propofol Medium Chain/Long Chain Triglyceride And Propofol Medium Chain/Long Chain Triglyceride With Lignocaine On Injection Pain

摘要

A common drawback of propofol is pain on injection and lignocaine is commonly mixed with propofol to reduce its incidence and severity. In this study we sought to compare the effectiveness of propofol medium chain and long chain triglyceride (MCT/LCT ) alone in comparison to propofol medium chain and long chain triglyceride (MCT/ LCT) premixed with lignocaine in preventing propofol pain on injection. 200 patients were randomly divided into two groups. Group A received propofol – MCT/LCT premixed with normal saline and group B received propofol- MCT/LCT premixed with 20 mg lignocaine. The incidence of pain in group A was 63% compared to 15% in group B (Χ2 = 48.242 ,p< 0.001). To conclude propofol MCT/LCT alone provides no advantage to reduce pain on injection in comparison to propofol MCT/LCT premixed with lignocaine. Introduction Propofol is a popular intravenous anaesthetic agent providing smooth induction and rapid recovery from anaesthesia. However pain on injection is a major disadvantage with a reported incidence of approximately 70% when a standard formulation of propofol is administered with no intervention to reduce pain.(1) Several strategies have been applied to alleviate pain, such as previous administration of opioids or metoclopromide and adaptation of the temperature of the emulsion. The most frequently used method to reduce pain is the administration of lignocaine, either before propofol injection, with or without a tourniquet (2) or added to the propofol emulsion as a premixture.(1,3,4) The mechanism of pain relief can be two fold ; first by reduction of propofol in the aqueous phase and second by lignocaine acting as a stabiliser in the kinin cascade.(5) Injection pain has been attributed to the amount of free propofol in the aqueous phase of the emulsion. In 1997, Doenicke et al (6) advocated a reformulated lipid emulsion of propofol to alleviate injection pain. This reformulation of propofol contains both medium chain triglycerides (MCT) and long chain triglycerides (LCT) in equal proportions in contrast to usual LCT formulation. The amount of free propofol in a MCT/LCT emulsion is assumed to be less compared with propofol LCT thus causing less pain on injection. However recent studies have suggested that propofol MCT/LCT emulsion when used alone causes more pain on injection as compared to propofol LCT with lignocaine.(7,8,9)The aim of this study was to determine whether propofol in a reformulated MCT/LCT emulsion without further addition was more effective in preventing pain on injection as compared to propofol MCT/LCT with lignocaine and more frequently used standard LCT propofol with a premixture of lignocaine. Material and Methods Following approval by the institutional ethics committee and written informed consent, 300 ASA I-III patients aged 18-65 years scheduled for elective surgery under general anaesthesia were recruited into this prospective randomised double blind study. Sample size was determined by performing a power analysis which showed that a minimum of 200 patients will be required for the study. Exclusion criteria were patients with ischemic heart disease and neurological problems, pregnant or lactating patients, those who were taking any analgesics before surgery, or those with known hypersensitivity to propofol or to any of the constituents of the emulsion (soy-bean oil, MCT, glycerol, egg lecithin, sodium oleate or water for injection).The drugs used were propofol –MCT/LCT (PropofolR-Lipuro, B Braun Ltd, Melsungen, Germany) and lignocaine hydrochloride 2% (XylocardR , AstraZeneca, India).The patients were assigned to 2 groups using computer generated randomizatiopn with 100 patients in each group. Group A received propofol – MCT/LCT premixed with normal saline ( 1 ml of normal saline added to 19 ml propofol-lipuro). Group B received propofol- MCT/LCT premixed with lignocaine (1 ml of 2% lignocaine added to 19 ml propofol- lipuro).Patients received no premedication. On arrival at the ope