Lidocaine + Clonidine for Intraoral Anesthesia in Patients With Diabetes Mellitus Type 2 (LCIOADMT2)

University of Belgrade

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus; Local Anesthesia

Treatments: Drug: L+E mandibular anesthesia; Drug: L+E maxillary anesthesia; Drug: L+C maxillary anesthesia; Drug: L+C mandibular anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02371759

UBelgrade 534/2

175021 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to determine whether 2% lidocaine (L) + clonidine (C) (15 mcg/ml) as a vasoconstrictor achieves efficient (equal or better parameters of intraoral local anesthesia in comparison to 2% lidocaine + epinephrine (E) (1:80 000)) and safe (stable cardiovascular parameters - systolic, diastolic, mean blood pressure and heart rate) intraoral local anesthesia in patients with Diabetes mellitus type 2.

Full description

Patients with diabetes mellitus type 2, represent a risk for performing regional anesthesia techniques due to microvascular (microangiopathy, neuropathy) and macrovascular (hypertension, coronary heart disease) complications. There is evidence that local anesthetic toxicity may be increased in diabetic setting due to underlying neuropathy; while interaction of diabetic blood vessels with vasoconstrictors may be of importance because of microangiopathic changes. Lately, regional anesthesia protocol in general surgery for patients with diabetes mellitus was released, proposing reduction of local anesthetic concentration and avoiding epinephrine as vasoconstrictor.

Oral cavity tissues in diabetes mellitus also suffer from neuropathy (burning, paresthesia, teeth loss, temporomandibular dysfunction, xerostomia) and microangiopathy (periodontal disease, salivary gland dysfunction). Most widely used vasoconstrictor for intraoral local anesthesia, epinephrine, is an alpha- and beta- adrenergic agonist. Because of its beta-adrenergic effects, epinephrine could adversely affect cardiovascular function, especially in risk patients. There are data suggesting that intraoral local anesthesia obtained with 2% lidocaine with clonidine, selective alpha 2-adrenoceptor agonist as a vasoconstrictor, is characterized with significantly more stable cardiovascular parameters and similar parameters of local anesthesia with respect to lidocaine with epinephrine in healthy and hypertensive patients.

With regard to aforementioned, the aim of this randomized double-blind controlled clinical trial is to evaluate and compare efficacy and safety of intraoral local anesthesia obtained with 2% lidocaine (L) + clonidine (15 mcg/ml) (C) or 2% L + epinephrine (1:80 000) (E), comparing healthy and diabetes mellitus type 2 patients. Prior to tooth extraction, random allocation to one of four groups (L+C maxillary infiltration, L+C mandibular block, L+E maxillary infiltration and L+E mandibular block) is performed for diabetic (30 per group) and healthy (30 per group) patients. Parameters of local anesthesia (onset, duration, intensity, width of anesthetic field for maxillary infiltration), cardiovascular parameters (systolic, diastolic, mean arterial pressure; heart rate and electrocardiographic changes), quality of postoperative analgesia (assessed by Visual Analogue Scale, Numerical Rating Scale and number of consumed analgesics) and postoperative complications (infection, bleeding, paresthesia, delayed wound healing) are evaluated and compared.

Enrollment: 256 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy participants: ASA I
• Diabetic type 2 participants: ASA III (HbA1c level < 9%)
• Required a single-root teeth indicated for non-complicated extraction
• Dental diagnosis of periodontal disease, tooth fracture, chronic periapical lesion and root infection
• Subjects give informed written consent

Exclusion criteria

• Pregnancy and lactation
• Allergy to used drugs and food
• Hepatic and/or renal failure
• ASA IV patients
• Tobacco smokers
• History of alcoholism and/or drug abuse and addiction

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 8 patient groups

Diabetics: L+C maxillary anesthesia

Experimental group

Description:

Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia

Treatment:

Drug: L+C maxillary anesthesia

Diabetics: L+C mandibular anesthesia

Experimental group

Description:

Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia

Treatment:

Drug: L+C mandibular anesthesia

Diabetics: L+E maxillary anesthesia

Active Comparator group

Description:

Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia

Treatment:

Drug: L+E maxillary anesthesia

Diabetics: L+E mandibular anesthesia

Active Comparator group

Description:

Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia

Treatment:

Drug: L+E mandibular anesthesia

Healthy: L+C maxillary anesthesia

Experimental group

Description:

Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia

Treatment:

Drug: L+C maxillary anesthesia

Healthy: L+C mandibular anesthesia

Experimental group

Description:

Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia

Treatment:

Drug: L+C mandibular anesthesia

Healthy: L+E maxillary anesthesia

Active Comparator group

Description:

Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia

Treatment:

Drug: L+E maxillary anesthesia

Healthy: L+E mandibular anesthesia

Active Comparator group

Description:

Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia

Treatment:

Drug: L+E mandibular anesthesia