Is Tramadol Hydrochloride with Adrenaline an Alternative to Lignocaine Hydrochloride with Adrenaline in Dental Implant Surgery ?? – A Randomized Controlled Clinical Trial

Background: When used as infiltration anesthesia, tramadol is known to provide a local anesthetic effect. Objectives: The purpose of this study was to examine the anesthetic potency of local infiltrations of 5% tramadol hydrochloride with adrenaline and 2% lignocaine hydrochloride with adrenaline in dental implant procedures. To assess tramadol postoperative analgesia's onset, duration, potency, and effectiveness as a local anesthetic agent. Expected Result: The study was carried out to check potency of Tramadol hydrochloride with adrenaline to lignocaine hydrochloride in dental implant surgery, it had similar efficacy and used as an alternative where lignocaine was contraindicated. Conclusion: Tramadol hydrochloride with adrenaline was used as an alternative to lignocaine hydrochloride in selected cases, if the study proves.


INTRODUCTION
Pain serves as the inspiration for pioneering efforts by dentists to control pain as it has always been a barrier to dentistry. Pain is defined "an uncomfortable frame of mind that may have a physical basis in something that is being done to the body, or may be purely mental" in 1906 [1,2]. Many people avoid dental clinics due the associated pain which leads to anxiety. The most commonly followed method for blocking pain during oral surgical procedures is done by using Local anesthesia [3]. Amide linkage for local anesthetic with the formulation of lignocaine was introduced during second era which was developed by Nils Lofgren, the most widely used cocaine derivative, during World War II in 1943 Due to the near ideal properties, it represents the gold standard drug, so all new local anesthetics are compared to it [5,6,7]. Allergy to lignocaine is rare but if present then what will be the alternative? It is mostly raising question. Drugs from other group or other drug from same group is advocated in literature, but in day to day practice other drug's availability is questionable. In the search of newer alternative local anesthetic agents, tramadol hydrochloride is one of them, which is available easily.
Since Tramadol is synthetic opioid in aminocyclohexanol group, therefore is a centrally acting analgesic selective for µ receptor. It is shown to have a local anaesthetic effect which is alike to lignocaine after intradermal injections. Opioids nerve conduction blocking effect have been demonstrated in both animal and clinical studies. In this study the researchers evaluated its local anaesthetic efficacy in commonly performed dental implant procedures [8].

Aims and Objectives
To compare anesthetic potency of local infiltration of 5% tramadol hydrochloride with adrenaline and 2% lignocaine hydrochloride with adrenaline, in dental implant procedures. To evaluate onset, duration, potency and tramadol postoperative analgesia is examined as a local anesthetic agent.

MATERIALS AND METHODOLOGY
A split mouth study will be conducted in the Outpatient Department of Oral and Maxillofacial Surgery, of Sharad Pawar Dental College, Sawangi, district Wardha, Maharashtra. Sample size will be appx. 80. Therefore, a total number of 80 patients who needed dental implants will be selected. The subjects will be classified in two groups. This will be a split mouth study with 40 sample size. Patients will be selected randomly regardless of their gender, religion and caste. A written consent will be obtained from all the patients. During implant surgery in patients who receive tramadol infiltration, subjective and objective signs will be noted. If pain persists beyond VAS 4, the conventional method of anesthesia with lignocaine will be use in that case. The patient will be periodically questioned about pain and following the surgery all the patients will be asked to score pain experience during the procedure on 100mm VAS scale (Visual Analogue Scale). The patients will be asked to assign scores for each parameter at intervals of 1hrs, 2hrs, 3hrs, 4hrs, 5hrs and 6hrs from the onset of anesthesia. Further any adverse effects will also recorded after 24 hrs follow up such as Nausea and Vomiting. Blood pressure and heart rate will be recorded pre, intra and postoperatively.  [10] prospectively compared anesthetic efficacy of tramadol and lignocaine hydrochloride with adrenaline in simple exodontia. The study was conducted on 50 patients accessing onset of anesthesia and pain. They suggested that wherever Lignocaine HCL is contraindicated Tramadol HCL with adrenaline can be used as an alternative with added advantage of no reversal drug or post op analgesia needed. While Shoeb Kasim Jendi, Ahmed M. Syed, Sheeraz Badal, Amol Doiphode, Sandesh S. Chougule, Sameer A. Shaikh, Ahmed Ahtesham [2019] [11] performed a study over 100 patients to compare potency of tramadol with that of lignocaine as local anesthetic for exodontia in terms of their onset and duration of action, intraoperative and post-operative pain and adverse reactions.

DISCUSSION
They conclude that 5% tramadol and 2% lignocaine has similar local anesthetic efficacy but tramadol is comparatively weaker. In a study done by Bilal Ege, Miray Ege, Mahmut Koparal, Hilal Alan [2019] [12] compared the anesthetic potency of tramadol hydrochloride and lignocaine in 32 selected patients who required bilaterally orthodontic maxillary first premolar extractions. There were no differences noted between the solutions for the anesthetic onset, lignocaine was statistically more efficient for total anesthesia duration [13]. In terms of postoperative pain, it was found when tramadol was compared with it, the VAS scores with lignocaine were higher. In general, the tramadol values were dramatically lower than lignocaine values, which suggested that using tramadol along with epinephrine can be used as an alternative for local anesthetic for maxillary first premolar tooth extractions during oral maxillofacial surgery.

IMPLICATION
Lignocaine being a gold standard drug is most commonly used as a local anesthesia during oral surgical procedures, however an alternative drug is required when lignocaine cannot be used or is contra indicated . In such cases tramadol may be an effective pain alleviating agent.

CONCLUSION
Tramadol hydrochloride with adrenaline may be used as an alternative to lignocaine hydrochloride in selected cases, if the study proves.

CONSENT
As per international standard or university standard, patients' written consent will be collected and preserved by the author(s).

ETHICAL APPROVAL
As per international standard or university standard written ethical approval will be collected and preserved by the author(s).