Clinical Trial: Mepivacaine-Tramadol on the Success of Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.

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.



Original Primary Outcome: Same as current

Current Secondary Outcome: Anesthetic effect duration [ Time Frame: 0-14 hours ]

The time of the anesthetic effect will be evaluated in patients in whom anesthetic success is achieved, and also the consume of emergency and rescue post-operative analgesics. Side effects will also be monitored during this period.


Original Secondary Outcome: Same as current

Information By: Universidad Autonoma de San Luis Potosí

Dates:
Date Received: April 8, 2014
Date Started: April 2014
Date Completion:
Last Updated: October 30, 2014
Last Verified: October 2014