NCT02110966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

April 8, 2014

Last Update Submit

October 30, 2014

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Anaesthetic effectInferior alveolar nerve blockLocal tramadolMepivacaineSymptomatic irreversible pulpitis.

Outcome Measures

Primary Outcomes (1)

  • success of the inferior alveolar nerve block

    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 Outcomes (1)

  • Anesthetic effect duration

    0-14 hours

Study Arms (2)

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

Drug: Mepivacaine plus Tramadol

Mepivacaine

ACTIVE COMPARATOR

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

Drug: Mepivacaine

Interventions

MepivacaineDRUG

Drug: Tramadol 1.8 ml of Mepivacaine 2% epinephrine 1:100000.

Also known as: Dentocaín
Mepivacaine
Mepivacaine plus TramadolDRUG

0.5 ml of Tramadol mixed with 1.3 ml of Mepivacaine.

Also known as: Tradol
Mepivacaine plus Tramadol

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endodontics Master Degree program, Dentistry Faculty, San Luis Potosi University

San Luis Potosí City, San Luis Potosí, 78290, Mexico

Location

Related Publications (18)

  • Walton RE, Torabinejad M. Managing local anesthesia problems in the endodontic patient. J Am Dent Assoc. 1992 May;123(5):97-102. doi: 10.14219/jada.archive.1992.0133.

    PMID: 1597649BACKGROUND

  • Hellstrom PM, Husebye E, Kraglund K. Methodology for motility studies on the small intestine: a Scandinavian consensus. Eur J Surg Suppl. 1991;(564):51-61. No abstract available.

    PMID: 1718505BACKGROUND

  • Cohen HP, Cha BY, Spangberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3. doi: 10.1016/S0099-2399(06)81366-X.

    PMID: 8245762BACKGROUND

  • Henry MA, Hargreaves KM. Peripheral mechanisms of odontogenic pain. Dent Clin North Am. 2007 Jan;51(1):19-44, v. doi: 10.1016/j.cden.2006.09.007.

    PMID: 17185058BACKGROUND

  • Noguera-Gonzalez D, Cerda-Cristerna BI, Chavarria-Bolanos D, Flores-Reyes H, Pozos-Guillen A. Efficacy of preoperative ibuprofen on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a randomized clinical trial. Int Endod J. 2013 Nov;46(11):1056-62. doi: 10.1111/iej.12099. Epub 2013 Apr 6.

    PMID: 23561002BACKGROUND

  • Kargi E, Babuccu O, Altunkaya H, Hosnuter M, Ozer Y, Babuccu B, Payasli C. Tramadol as a local anaesthetic in tendon repair surgery of the hand. J Int Med Res. 2008 Sep-Oct;36(5):971-8. doi: 10.1177/147323000803600513.

    PMID: 18831890BACKGROUND

  • Sawynok J. Topical and peripherally acting analgesics. Pharmacol Rev. 2003 Mar;55(1):1-20. doi: 10.1124/pr.55.1.1.

    PMID: 12615951BACKGROUND

  • Stein C, Lang LJ. Peripheral mechanisms of opioid analgesia. Curr Opin Pharmacol. 2009 Feb;9(1):3-8. doi: 10.1016/j.coph.2008.12.009. Epub 2009 Jan 20.

    PMID: 19157985BACKGROUND

  • Isiordia-Espinoza MA, Pozos-Guillen AJ, Martinez-Rider R, Herrera-Abarca JE, Perez-Urizar J. Preemptive analgesic effectiveness of oral ketorolac plus local tramadol after impacted mandibular third molar surgery. Med Oral Patol Oral Cir Bucal. 2011 Sep 1;16(6):e776-80. doi: 10.4317/medoral.16854.

    PMID: 21217614RESULT

  • Wang JT, Chung CC, Whitehead RA, Schwarz SK, Ries CR, MacLeod BA. Effects of local tramadol administration on peripheral glutamate-induced nociceptive behaviour in mice. Can J Anaesth. 2010 Jul;57(7):659-63. doi: 10.1007/s12630-010-9301-9. Epub 2010 Mar 26.

    PMID: 20340056RESULT

  • Robaux S, Blunt C, Viel E, Cuvillon P, Nouguier P, Dautel G, Boileau S, Girard F, Bouaziz H. Tramadol added to 1.5% mepivacaine for axillary brachial plexus block improves postoperative analgesia dose-dependently. Anesth Analg. 2004 Apr;98(4):1172-1177. doi: 10.1213/01.ANE.0000108966.84797.72.

    PMID: 15041620RESULT

  • Guven M, Mert T, Gunay I. Effects of tramadol on nerve action potentials in rat: comparisons with benzocaine and lidocaine. Int J Neurosci. 2005 Mar;115(3):339-49. doi: 10.1080/00207450590520948.

    PMID: 15804720RESULT

  • Isiordia-Espinoza MA, Orozco-Solis M, Tobias-Azua FJ, Mendez-Gutierrez EP. Submucous tramadol increases the anesthetic efficacy of mepivacaine with epinephrine in inferior alveolar nerve block. Br J Oral Maxillofac Surg. 2012 Mar;50(2):157-60. doi: 10.1016/j.bjoms.2011.02.010. Epub 2011 May 8.

    PMID: 21555171RESULT

  • Altunkaya H, Ozer Y, Kargi E, Ozkocak I, Hosnuter M, Demirel CB, Babuccu O. The postoperative analgesic effect of tramadol when used as subcutaneous local anesthetic. Anesth Analg. 2004 Nov;99(5):1461-1464. doi: 10.1213/01.ANE.0000135640.21229.A0.

    PMID: 15502049RESULT

  • Pozos AJ, Martinez R, Aguirre P, Perez J. The effects of tramadol added to articaine on anesthesia duration. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):614-7. doi: 10.1016/j.tripleo.2006.01.017. Epub 2006 Jul 27.

    PMID: 17052637RESULT

  • Kapral S, Gollmann G, Waltl B, Likar R, Sladen RN, Weinstabl C, Lehofer F. Tramadol added to mepivacaine prolongs the duration of an axillary brachial plexus blockade. Anesth Analg. 1999 Apr;88(4):853-6. doi: 10.1097/00000539-199904000-00032.

    PMID: 10195537RESULT

  • Ceccheti MM, Negrato GV, Peres MP, Deboni MC, Naclerio-Homem Mda G. Analgesic and adjuvant anesthetic effect of submucosal tramadol after mandibular third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Mar;117(3):e249-54. doi: 10.1016/j.oooo.2012.05.015. Epub 2012 Sep 12.

    PMID: 22981094RESULT

  • Pozos AJ, Martinez R, Aguirre P, Perez J. Tramadol administered in a combination of routes for reducing pain after removal of an impacted mandibular third molar. J Oral Maxillofac Surg. 2007 Aug;65(8):1633-9. doi: 10.1016/j.joms.2006.06.267. No abstract available.

    PMID: 17656294RESULT

MeSH Terms

Interventions

MepivacaineTramadol

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Laura Rodríguez, DDS

    Universidad Autónoma San Luis Potosí

    PRINCIPAL INVESTIGATOR

  • Daniel Chavarria, MSc, PhD

    Universidad Autonoma San Luis Potosi

    STUDY DIRECTOR

  • Amaury Pozos, MSc, PhD

    Universidad Autonoma San Luis Potosi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Basic Sciences Laboratory, Dentistry School

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 10, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations

ME(1)