Evaluation of Adding Lidocaine to Dexamethasone in Intra-tympanic Injection for Management of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Importance; Tinnitus is a heterogeneous diagnosis that may occur alone, in the presence of
      hearing loss or as a component of other disorders and can be quite disabling. Intratympanic
      injections of medications recently proved to have role in management of tinnitus. The
      investigators report on our experience with the use of intratympanic injection of Lidocaine
      as local anesthetic which potentiate the action of dexthamesasone in treatment of tinnitus
      without adding potential risks of inner ear Objective; to describe the effect of Lidocaine as
      local anesthetic may potentiate the action of dexthamesasone intratympanic injection in
      treatment of tinnitus without adding potential risks of inner ear Design, Setting,
      participants ; For this single tertiary center( Tanta University Hospital ) prospective case
      series, the investigators included 44 patients divided into two groups (A and B) 22 patients
      in each group suffering from tinnitus between March 2015 and October 2015 Intervention; Under
      local anesthesia 22 patients were subjected to intratympanic injection with combined
      Lidocaine 2% and dexamethasone with ratio (1:1), in the group A, and 22 patients in the other
      group B were subjected to intratympanic injection with dexamethasone only , this process was
      repeated 3 times for 3 successive weeks.

      Main Outcome and Measures; the primary outcome is self-reported significant improve in
      tinnitus in group A more in group B without adding significant damage of inner ear
    

Detailed description: 
      Introduction Tinnitus is a heterogeneous diagnosis that may occur alone, in the presence of
      hearing loss, or as a component of other disorders and can be quite disabling. Tinnitus has
      been estimated to affect over 10% of population.1 Attempts to treat and classify tinnitus
      date back to ancient Egypt. The Ebers Papyrus includes great detail regarding the "treatment
      for a bewitched ear'' Infusion of medicine into the ear were common at this time. (2500 BC).2
      It is more prevalent in patients between the ages of 50 and 70 years, with men over 65 years
      being afflicted more often than women of similar age. 3-4 Tinnitus has complex
      pathophysiology which is difficult to understand and investigate. Many studies have indicated
      that, it usually occurs due to redirection of information and the role of the non-classical
      auditory pathways, changes in synaptic efficacy can open connections in the CNS that are
      normally not conducting and that can redirect information in the CNS. 5 Subjective tinnitus
      is conscious perception of phantom sound, which is audible by the patients only and affects
      their routine life. Many therapies and drugs have been used in the treatment of tinnitus,
      such as dietary modification, tinnitus retraining therapy, antidepressants, anxiolytics, and
      herbal medicines. However, no significant improvement has been found in the majority of the
      patients treated by these therapies or drugs. Various attempts have been made to treat
      peripheral tinnitus since the 1940s, by way of intra tympanic injection. This administration
      procedure requires only low concentrations of medication and comes with minimal systemic
      exposure thus avoiding serious systemic side effects. 6 Intra-tympanic treatment of tinnitus
      with Lidocaine, Corticosteroids and\or Aminoglycosides has been used to treat disabling
      symptoms of tinnitus with different results. 7 Intra-tympanic drug perfusion, has been
      successively used to treat tinnitus since the 1990s.4 Lidocaine (Xylocaine), also called
      lignocaine, is a potent local anesthetic agent, widely used both topical and injection
      anesthesia. The mechanism of action of Lidocaine on the auditory system in the subjective
      tinnitus is controversial as it has central and peripheral action. 7 Therefore, this study
      was designed in a prospective randomized controlled fashion to evaluate the efficacy and
      safety of adding Lidocaine to dexamethasone in treatment of idiopathic subjective tinnitus.

      Methods:

      Trial Designs Two identical, prospective, double-blind controlled Single center randomized
      clinical trials assessed the effectiveness, safety, and tolerability of adding Lidocaine to
      dexamethasone in intratympanic injection in patients with idiopathic subjective tinnitus (age
      range 30 to 63 years). The study design and consent forms were approved by the research
      ethics committee of Tanta university hospitals. The study was conducted according to the
      Declaration of Helsinki and a written informed consent was obtained from every patient who
      agreed to participate in the study.

      The study was carried out on 44 patients suffering from prominent unilateral idiopathic
      subjective non-pulsatile tinnitus (IST) attending to the outpatient clinic of
      otorhinolaryngology department of the Tanta University Hospital, from March 2015 to October
      2015. They were 18 male and 26 female, with age ranged from 30 to 63 years old (mean
      48.909±7.758). Patients were equally divided into two groups (A and B). Group A was injected
      by combined Lidocaine 2% and dexamethasone 8mg/2ml. Group B was injected only by
      dexamethasone 8mg/2ml. Exclusion criteria included Extreme age, pulsatile tinnitus, objective
      tinnitus and ear inflammation.

      Randomization and Trial Intervention Every patient was given a code number in the study to
      keep his personal information confidential. Adequate provisions to maintain privacy of
      participants and confidentiality of data were taken into consideration. To avoid selection
      bias, each candidate, who signed an informed consent for participation in the study, was
      given a number from one to forty four. For every two consecutive patients; the first was
      enrolled in group A and the second was enrolled in group B till the end of the 44 patients.

      Operative technique The drum was anaesthetized locally by cotton soaked with Xylocaine 10%.
      The patient was kept in supine position and his head turned about 45°away from the surgeon.
      All patients were injected by a single surgeon (dr saad elzayat,MD, consultant of ORL). The
      assigned solution was injected under direct vision through an operating microscope at the
      anterosuperior quadrant of the tympanic membrane using a 27-gauge needle. About one ml of the
      drug was injected in the diseased ear. In group A, the investigators used combined Lidocaine
      2% and dexamethasone (8mg/2ml) with ratio (1:1). In group B, the investigators used
      dexamethasone only for injection 8mg/2ml. The patients would remain in the supine position
      for about 30 minutes and avoid swallowing after the injection to keep the Eustachian tube
      closed and give the drug maximal time of contact with the round window. The patients were
      kept in our department for six hours for observation of any complications. This procedure was
      repeated for three times at weekly interval.

      Follow up visits were scheduled one month, 3 months and six months from the first injection.
      Before and after injection, each patient was asked to complete Tinnitus Handicap Inventory
      (THI) and Tinnitus Functional Index (TFI) questionnaires. Full otological, audiological
      examination and adverse events were recorded.

      Statistical Analysis Sample size was calculated as 22 patients in each group to give the
      study a power of 80% at the 5% level of significance. At the time of randomization and during
      the follow up period, both the patient and the surgeon were unaware of the group assignment.
      Each patient was coded; these codes were kept with the main investigator. The envelope was
      opened on the day of the operation. During the follow up period, the patient was assigned to
      the principal investigator of the thesis. The study sheet summarized all the information
      related to the patient except the operative data. The sheet was copied and added to the
      patient file after each session, whereas the original sheet was kept in the study folder.
      Statistical presentation and analysis of the present study was conducted, using SPSS V17.
      Chicago IL, SPSS Inc®)
    

Intervention name(s): Intra-tympanic injection of drugs; Data management of intratympanic drugs
Intervention type(s): Drug; Other
Intervention description(s): Intratympanic injection of combined lidocaine and dexamethasone in treatment of tinnitus; intervention by statistical analysis of Intratympanic injection of combined lidocaine and dexamethasone in treatment of tinnitus
Other intervention name(s): Lidocaine in tinnitus
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Tinnitus; Intra-tympanic; Lidocaine; Dexamethasone