Mepivacaine-Tramadol on the Success of Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 4

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 description: 
      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.

      Thus, the aim of the study is to evaluate the success of inferior alveolar nerve block with
      the local application of Mepivacaine plus Tramadol in patients with symptomatic irreversible
      pulpitis, and also to evaluate the duration of the anesthetic effect when using Mepivacaine
      plus Tramadol in the anesthetic technique. This study was designed as a double-blind,
      randomized clinical trial. Following the guidelines suggested by CONSORT group for planning
      and reporting clinical trials. The ethics committee of the Faculty of Dentistry of San Luis
      Potosi University approved the study design. All of the subjects will be informed of the
      possible risk of endodontic therapy and experimental treatments and will sign institutionally
      approved consents forms.

      In total 50 patients will be included in this study. The sample size calculation was
      performed with a Type I error of 0.05 and statical power of 80% using the difference in
      duration of anesthetic effect between two groups and taking into account previous studies
      related to the local effect of tramadol in clinical studies where it is used to assess the
      time of anesthetic effect.

      All the subjects voluntarily will presented at the Postgraduate Endodontics Clinic of the
      Faculty of Dentistry at San Luis Potosi University. The select subjects will have a diagnosis
      of symptomatic irreversible pulpitis in the first and second mandibular molars.

      The patients will be diagnosing with the cold test and they will indicate their pain scores
      using numerical rating scale, this is a 11 point scale where the ends points are the extremes
      of no pain and the worst pain. Accordingly, no pain corresponded with 0, mild pain with 1-3,
      moderate pain with 4-6 and severe pain 7-10. The control group will receive the inferior
      alveolar nerve block using 1.8 ml of Mepivacaine 2% epinephrine 1: 100000 and 1.3 ml of
      Mepivacaine 2% epinephrine 1:100000 mixed with 0.5 ml of Tramadol (50mg/ml) will be used for
      the anaesthetic blockade in the experimental group. After 15 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.

      Statics normal distribution will be tested by the student's t test. A non-parametric chi-
      squared test was performed to identify statistically differences between the groups; the
      level of significance was set at p˂ 0.05.
    

Intervention name(s): Mepivacaine; Mepivacaine plus Tramadol
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Tramadol 1.8 ml of Mepivacaine 2% epinephrine 1:100000.; 0.5 ml of Tramadol mixed with 1.3 ml of Mepivacaine.
Other intervention name(s): Dentocaín; Tradol
Intervention MeSH terms: Tramadol; Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anaesthetic effect; Inferior alveolar nerve block; Local tramadol; Mepivacaine; Symptomatic irreversible pulpitis.