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

October 30, 2014 updated by: Daniel Chavarría Bolaños

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosi, Mexico, 78290
        • Endodontics Master Degree program, Dentistry Faculty, San Luis Potosi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mepivacaine plus Tramadol
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
Drug: Mepivacaine plus Tramadol
0.5 ml of Tramadol mixed with 1.3 ml of Mepivacaine.
Other Names:
  • Tradol
Active Comparator: Mepivacaine
The control group will receive the inferior alveolar nerve block using 1.8 ml of Mepivacaine 2% epinephrine 1: 100000.
Drug: Mepivacaine
Drug: Tramadol 1.8 ml of Mepivacaine 2% epinephrine 1:100000.
Other Names:
  • Dentocaín

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of the inferior alveolar nerve block
Time Frame: 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.
0-30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-14 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Chavarría Bolaños

Investigators

  • Principal Investigator: Laura Rodríguez, DDS, Universidad Autonoma San Luis Potosi
  • Study Director: Daniel Chavarria, MSc, PhD, Universidad Autonoma San Luis Potosi
  • Study Chair: Amaury Pozos, MSc, PhD, Universidad Autonoma San Luis Potosi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIFE-008-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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