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

Diabetes Mellitus Clinical Trial

— LCIOADMT2  

Official title:

Efficacy and Safety of Intraoral Local Anesthesia by Lidocaine + Clonidine in Patients With Diabetes Mellitus Type 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371759
• Other study ID #: UBelgrade 534/2
• Secondary ID: 175021
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2015
• Last updated: March 13, 2016
• Start date: June 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Local Anesthesia

Intervention

Procedure:
• L+C maxillary anesthesia
Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
• L+C mandibular anesthesia
Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
• L+E maxillary anesthesia
Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
• L+E mandibular anesthesia
Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)

Locations

Country	Name	City	State
Serbia	School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of intraoral local anesthesia	Time until cessation in soft tissue numbness	Up to 6 hours after local anesthesia injection	No
Primary	Intensity of intraoral local anesthesia	Pain assessment by Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS) during tooth extraction	Up to 10 minutes after local anesthesia injection	No
Primary	Change from baseline in systolic blood pressure at 5 minutes	Clinically significant changes in systolic blood pressure at the time of local anesthesia injection	baseline, 5 minutes	Yes
Primary	Change from baseline in systolic blood pressure at 10 minutes	Clinically significant changes in systolic blood pressure 5 minutes after local anesthesia injection	baseline, 10 minutes	Yes
Primary	Change from baseline in systolic blood pressure at 15 minutes	Clinically significant changes in systolic blood pressure 10 minutes after local anesthesia injection	baseline, 15 minutes	Yes
Primary	Change from baseline in systolic blood pressure at 20 minutes	Clinically significant changes in systolic blood pressure 15 minutes after local anesthesia injection	baseline, 20 minutes	Yes
Primary	Change from baseline in systolic blood pressure at 35 minutes	Clinically significant changes in systolic blood pressure 30 minutes after local anesthesia injection	baseline, 35 minutes	Yes
Primary	Change from baseline in diastolic blood pressure at 5 minutes	Clinically significant changes in diastolic blood pressure at the time of local anesthesia injection	baseline, 5 minutes	Yes
Primary	Change from baseline in diastolic blood pressure at 10 minutes	Clinically significant changes in diastolic blood pressure 5 minutes after local anesthesia injection	baseline, 10 minutes	Yes
Primary	Change from baseline in diastolic blood pressure at 15 minutes	Clinically significant changes in diastolic blood pressure 10 minutes after local anesthesia injection	baseline,15 minutes	Yes
Primary	Change from baseline in diastolic blood pressure at 20 minutes	Clinically significant changes in diastolic blood pressure 15 minutes after local anesthesia injection	baseline, 20 minutes	Yes
Primary	Change from baseline in diastolic blood pressure at 35 minutes	Clinically significant changes in diastolic blood pressure 30 minutes after local anesthesia injection	baseline, 35 minutes	Yes
Primary	Change from baseline in heart rate at 5 minutes	Clinically significant changes in heart rate at the time of local anesthesia injection	baseline, 5 minutes	Yes
Primary	Change from baseline in heart rate at 10 minutes	Clinically significant changes in heart rate 5 minutes after local anesthesia injection	baseline, 10 minutes	Yes
Primary	Change from baseline in heart rate at 15 minutes	Clinically significant changes in heart rate 10 minutes after local anesthesia injection	baseline, 15 minutes	Yes
Primary	Change from baseline in heart rate at 20 minutes	Clinically significant changes in heart rate 15 minutes after local anesthesia injection	baseline, 20 minutes	Yes
Primary	Change from baseline in heart rate at 35 minutes	Clinically significant changes in heart rate 30 minutes after local anesthesia injection	baseline, 35 minutes	Yes
Primary	Change from baseline in electrocardiogram at 5 minutes	Clinically significant changes in ECG at the time of local anesthesia injection	baseline, 5 minutes	Yes
Primary	Change from baseline in electrocardiogram at 10 minutes	Clinically significant changes in ECG 5 minutes after local anesthesia injection	baseline, 10 minutes	Yes
Primary	Change from baseline in electrocardiogram at 15 minutes	Clinically significant changes in ECG 10 minutes after local anesthesia injection	baseline, 15 minutes	Yes
Primary	Change from baseline in electrocardiogram at 20 minutes	Clinically significant changes in ECG 15 minutes after local anesthesia injection	baseline, 20 minutes	Yes
Secondary	Onset of intraoral local anesthesia	Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection	Up to 10 minutes, until subjective feeling of soft tissue numbnes	No
Secondary	Width of anesthetic field	Soft tissue numbness area determined by pin-prick	Up to 10 minutes after injection of local anesthesia	No
Secondary	Postoperative analgesia	Number of analgesic doses required for postoperative pain control, VAS, NRS	up to 24 hours after tooth extraction	No
Secondary	Local postoperative complications	Postoperative infection, postoperative bleeding, alveolitis, paresthesia, delayed wound healing by clinical examination	24 hours, 7 days	Yes