Efficacy and safety of lidocaine with clonidine for intraoral local anaesthesia in patients with diabetes mellitus type 2

Abstract

Introduction Patients with diabetes mellitus (DM) type 2 are at increased risk for performance of regional anaesthesia, due to macrovascular and microvascular complications of DM, including changes in small blood vessels of peripheral nerves (diabetic neuropathy). Results of experimental studies show that local anesthetics, even in clinically applicable concentrations, cause more pronounced damage to the nerves in the presence of DM, with clinically observable changes in parameters of regional anaesthesia. Neuropathic and microangiopathic changes caused by DM are also observed in the oral cavity tissues of DM patients. To date, there are no available data on efficacy and safety of intraoral local anaestehsia in patients with DM. Aims The aims of this doctoral dissertation were to test and compare efficacy and safety of intraoral local anaesthesia obtained with 2% lidocaine with clonidine (15 mcg / ml) (LC) and 2% lidocaine with epinephrine (1:80 000) (LE) in healthy and DM type 2 participants, by assessing the parameters of pulpal and soft tissues anaesthesia, pulpal blood flow, parameters of postoperative analgesia, presence of local side effects, as well as parameters of cardiovascular functions in the settings with and without oral surgical procedure. Material and method This prospective, double blind, randomized, controlled clinical study was performed in two parts. One part of the study included 36 healthy (ASA I) i 36 DM tip 2 participants (ASA II i ASA III), who received tested anaesthetic solutions (LC i LE) for maxillary infiltration anestehesia, in cross over-manner with washout period of 14 days, in the setting without oral surgical procedure. Tested parameters were: pulpal blood flow, parameters of pulpal anaesthesia and cardiovascular functions. Following part of the study involved 106 healthy (ASA I) i 127 DM tip 2 patients (ASA II i ASA III), divided into 8 groups according to health status, anaesthesia technique (infiltration, block) and tested anesthetic solution (LC, LE). In this study population the tested parameters were: soft tissue anaesthesia, postoperative analgesia, local side effects and cardiovascular parameters after infiltration and block application of either LC or LE, for extraction of single-rooted teeth in upper and lower jaw. Pulpal blood flow of maxillary central incisors was measured by laser Dopler flowmetry prior to, as well as 5, 10, 15, 30, 45 and 60 minutes after maxillary infiltration anaesthesia...

Uvod Pacijenti sa dijabetes melitusom (DM), zbog pratećih makrovaskularnih i mikrovaskularnih komplikacija osnovnog oboljenja, koje zahvataju i periferne nerve (dijabetična neuropatija), predstavljaju pacijente rizika za primenu regionalne anestezije. Pokazano je u eksperimentalnim uslovima da lokalni anestetici, u klinički primenljivim koncentracijama, izazivaju veća oštećenja na nervima izmenjenim dijabetičnom neuropatijom, što se u kliničkim uslovima manifestuje promenjenim parametrima regionalne anestezije. Promene koje DM izaziva na krvnim sudovima i nervima su zapažene i u tkivima i organima orofacijalne regije. Za sada nema podataka o parametrima i bezbednosti primene intraoralne lokalne anestezije u uslovima DM. Ciljevi Ovo istraživanje je imalo za ciljeve da ispita i uporedi efikasnost i bezbednost intraoralne lokalne anestezije postignute primenom 2% lidokaina sa klonidinom (15 mcg / ml) (LC) i 2% lidokaina sa epinefrinom (1:80 000) (LE) kod zdravih i ispitanika sa DM tip 2, praćenjem kliničkih parametara anestezije zubne pulpe i mekih tkiva, protoka krvi kroz zubnu pulpu, parametara postoperativne analgezije, učestalosti lokalnih neželjenih efekata, kao i parametara kardiovaskularne funkcije u uslovima sa i bez oralnohirurške intervencije. Materijal i metod Ova prospektivna, dvostruko slepa, randomizovana, kontrolisana klinička studija je izvedena u dva dela. U jednom delu studije učestvovalo je 36 zdravih (ASA I) i 36 ispitanika sa DM tip 2 (ASA II i ASA III), koji su u ukrštenom dizajnu istraživanja bez oralnohirurške intervencije, u razmaku od 14 dana dobili ispitivane anestetičke rastvore (LC i LE) za maksilarnu infiltracionu anesteziju, pri čemu su ispitivani protok krvi kroz zubnu pulpu maksilarnih centralnih sekutića, kao i parametri anestezije zubne pulpe i kardiovaskularne funkcije. U drugom delu studije učestvovalo je 106 zdravih (ASA I) i 127 ispitanika sa DM tip 2 (ASA II i ASA III), koji su prema zdravstvenom statusu, tehnici anestezije (infiltraciona, sprovodna) i vrsti anestetičkog rastvora (LC, LE) podeljeni u 8 grupa...