跳至主要内容
临床试验/NCT02110966
NCT02110966已完成4 期

Efficacy of the Combination Mepivacaine-Tramadol on the Success of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial.

Daniel Chavarría Bolaños1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
success of the inferior alveolar nerve block

研究概览

简要总结

The purpose of this study is to evaluate the success of inferior alveolar nerve block, after the local application of Mepivacaine plus Tramadol in patients with symptomatic irreversible pulpitis. Also, to evaluate the duration of the anesthetic effect when using Mepivacaine plus Tramadol in the same anesthetic technique and patients group.

Hypothesis:

Local application of mepivacaine plus tramadol increases the successful of inferior alveolar nerve block in patients with irreversible pulpitis.

详细描述

The treatment of pain is an integral part of Endodontics, this must be controlled before, during and after treatment. The inferior alveolar nerve block is the most common anesthetic technique used in mandibular teeth during endodontic treatments. Several studies have reported that it is more difficult to obtain anesthetic success in patients with irreversible pulpitis. There is a 33-80% of failure in the inferior alveolar nerve block in patients with irreversible pulpitis.

Some of the more accepted theories for local anesthetic failure establish that inflammation induce tissue acidosis causing ion traping of the local anesthetics enabling the molecules to cross the cell membrane, also inflammatory mediators may sensitize the neurons by interacting with specific receptors leading to periphery sensibilization. Tissue injury may alter the composition, distribution and activity of sodium channels expressed on nociceptors and this may have profound implications in local anesthetic failure. On the other hand, there is a specific group of tetrodotoxin resistant sodium channels four times less sensitive to lidocaine which increase their activity during inflammation.

Some ways to control pain is through pharmacological synergism. Tramadol has been proposed as pharmacological adjuvant to local anesthesia and it can improve the anesthetics success and the duration of the anesthetic effect. However, oral administration of drugs can cause adverse systemic effects, and that's why local application is an alternative to increase its concentration on the local damaged tissue reducing the possibility of interactions with other drugs and adverse effects. Another advantage of the combination of Mepivacaine with Tramadol is that it reduces the number of injections in patients and it is less traumatic.

Tramadol is centrally acting drug but also a local anesthetic and analgesic effect it has been reported. It acts at multiple sites producing different action mechanisms. Some studies suggest that the use of Tramadol can improve the effect of Mepivacaine in the inferior alveolar nerve block. The blockade of the nervous conduction with Tramadol is 80% more effective if it is compared with some anesthetics like lidocaine.

There are few studies evaluating local application of tramadol. In the field of dentistry tramadol using for local anesthetic adjuvant has been studied in oral surgery, so it is important to evaluate it in the field of endodontics to provide better pain management during treatments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects diagnosed with symptomatic irreversible pulpitis in the first and second mandibular molars.

排除标准

  • Pregnancy
  • Hypersensitivity to local anesthetics and Tramadol
  • Teeth with insufficient tooth structure for restoration, periodontal disease, root resorption, root fracture
  • Systemic diseases: diabetes, uncontrolled hypertension.
  • Patients taking drugs or narcotics.
  • Patients who have used analgesics in the last 8 hours.
  • Patients ingested IMAOS and tricyclic antidepressants 14 days before.
  • Patients ingested carbamazepine (anticonvulsants)
  • Patients in active treatment with ketoconazole and erythromycin.

研究组 & 干预措施

Mepivacaine plus Tramadol

Experimental

1.3 ml of Mepivacaine 2% epinephrine 1:100000 mixed with 0.5 ml of Tramadol (50mg/ml) will be used for the anesthetic blockade in the experimental group

干预措施: Mepivacaine plus Tramadol (Drug)

Mepivacaine

Active Comparator

The control group will receive the inferior alveolar nerve block using 1.8 ml of Mepivacaine 2% epinephrine 1: 100000.

干预措施: Mepivacaine (Drug)

结局指标

主要结局

success of the inferior alveolar nerve block

时间窗: 0-30 minutes

The anesthetic blockade will be assessed by a three step examination: lip numbess, positive/negative response to cold testing and clinical discomfort during endodontic access. Inferior alveolar nerve block success will be defined as the absence of pain during any of these evaluations and if patients report pain an analogue visual scale will be used. Also, the patient will reported the level of pain in the application of the inferior alveolar nerve block using mepivacaine and mepivacaine plus tramadol and local and systemic side effects will be monitored.

次要结局

  • Anesthetic effect duration(0-14 hours)

研究者

发起方
Daniel Chavarría Bolaños
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Chavarría Bolaños

Basic Sciences Laboratory, Dentistry School

Universidad Autonoma de San Luis Potosí

研究点 (1)

Loading locations...

相似试验