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Research Article | Volume 14 Issue: 3 (May-Jun, 2024) | Pages 224 - 228
The Impact of Intra-Ligamentry Tramadol Hydrochloride on Anaesthesia During Endodontic Treatment for Mandibular Molars: A Randomised Control Trial
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1
Department of Conservative Dentistry and Endodontics, Shrimant Madhavrao Scindia District Hospital, Vidisha
2
Graduate, karnavati School of Dentistry, Gandhinagar.
3
Department of Conservative Dentistry and Endodontics, Rajiv Gandhi Government Civil Hospital Ganj Basoda, Vidisha
4
Department of Conservative Dentistry and Endodontics, District Bhoj Hospital, Dhar
5
Senior Lecturer, Department of Oral Medicine and Radiology, Dental College Azamgarh, Azamgarh
6
Senior Lecturer, Department of Conservative Dentistry and Endodontics, Albadar Dental College and Hospital, Kalaburagi
Under a Creative Commons license
Open Access
PMID : 16359053
Received
March 6, 2024
Revised
March 21, 2024
Accepted
April 10, 2024
Published
May 6, 2024
Abstract

Introduction-One opioid that is physiologically similar to methylmorphine is tramadol hydrochloride. The topical administration of morphine to the de-sheathed saphenous nerve was tested in an experiment, which found that the medication in reverse blocked nerve transmission. Methodology- The prospective, active-controlled, triple-arm, double-blind randomized control clinical trial was carried out at Department of Conservative Dentistry and Endodontics, Shrimant Madhavrao Scindia District Hospital, Vidisha. Participants in this research were those who had undergone a primary inferior alveolar nerve block that had failed. The investigation lasted for a period of six months. The main measure of IANB's anaesthetic success was determined by the absence or mild pain (pain score ≤ of 54 on the Heft Parker visual analogue scale) throughout endodontic access cavity creation and root canal instruments, as well as a negative reaction to electric and thermal pulp sensitivity tests after 15 minutes of an injection. Results- 38 individuals had effective initial inferior alveolar nerve blocks (48 out of 153 patients, or 31% success rate). One of the three intraligamentary injections was administered to the rest 105 patients. The kind of teeth, age, and gender were not significantly different from one another. Conclusion: For mandibular molars with irreversible pulpitis refractory to IANB injections, an additional intraligamentary injection of tramadol to 2% lidocaine combined with 1:80,000 epinephrine can aid in successfully attaining anaesthesia throughout endodontic therapy.

Keywords
INTRODUCTION

For the majority of regular dental treatments, local anaesthesia is a necessary and typical element. The principal pharmaceutical approach to achieving local anaesthesia appropriate for dental and oral surgery processes involves the local management of an amide- or ester-based local anaesthetic the agent (e.g., procaine, articaine, or lidocaine/lignocaine) by means of infiltration or nerve blocking techniques. Because of their quick start, dependability, and safety profile, amide- based local anaesthetics are the most often used medicine in dentistry. Practitioners also prefer employing these above ester-based LA.1

The healthiest and most efficient way to avoid and alleviate pain is thought to be with local anaesthetics. 2There are certain limitations even though standard local anaesthetics (based on amides and ester) are thought to be safe. Due to the generation of metabolites called para-aminobenzoic acid, allergies to traditional local anaesthetics are exceedingly uncommon and have been linked more to ester-based agents than to amide-based ones.3 Patients may be allergic to latex diaphragms from dental cartridges or antioxidants and preservatives (such metabisulfite) used as supplements to local anaesthetics in the past. Occasionally, the delivery of an intravascular vasoconstrictor in conjunction with a local anaesthetic via injection may be misinterpreted as a "allergy" to the anaesthesia, instead of being acknowledged as a typically preventable and unintentional occurrence.4 The incidence of complications associated with conventional dental local anaesthetic agents has been reported to be 4.5%, with the most common being dizziness, tachycardia and agitation5, whereas others have reported a prevalence of up to 26%.6

One opioid that is chemically similar to methylmorphine is tramadol hydrochloride. The topical administration of morphine to the de-sheathed saphenous nerve was found to have a reversible inhibitory impact on nerve transmission, according to a research that assessed its effects. Pang et al.7 used intradermal injections of 0.5 mL each of tramadol, lidocaine, and saline on the volar surfaces of the forearms to assess the local anaesthetic impact of the drug. The two test solutions did not differ substantially from one another, according to the scientists, and both lidocaine and tramadol greatly lessen feelings of pain when contrasted with saline. Since then, a number of investigations have assessed tramadol's ability to provide local anaesthesia when administered either by itself or in conjunction with other local anaesthetics. The studies have reported that tramadol exerts local anesthetic properties similar to lidocaine.8 Hence, current prospective clinical trial aims to compare and evaluate the use of tramadol, administered as supplementary intraligamentary injections, after a failed primary inferior alveolar nerve block.

MATERIAL AND METHODS:

The study was carried out at Department of Conservative Dentistry and Endodontics, Shrimant Madhavrao Scindia District Hospital, Vidisha. The clinical trial was a triple-arm, double-blind, randomised, active-controlled study. Participants in the research were those who had undergone a primary inferior alveolar nerve block that had unsuccessful. The study lasted for a period of six months. The primary IANB's anaesthetic success was determined by the absence or mild pain (pain score ≤ of 54 on the Heft Parker visual analogue scale) during endodontic access cavity preparation and root canal instruments, as well as a negative reaction to electric and thermal pulp tests for sensitivity after 15 minutes of injections. The margin of error was set at 80% and the α errors were maintained at 0.05, respectively, according to information collected in an earlier investigation. The sample size calculations recommended including 35 patients per category, keeping the expected incidence of successful outcomes in the control group at 56%, in order to assess a difference of 30% in the test groups.

The American Society of Anaesthesiologists class I or II history of illness, manifesting symptoms irreversible pulpitis in an acute and extended response to electric and thermal tests, the presence of vital coronal pulp, and the patient's capacity to grasp and comprehend the utilisation of pain evaluations were the requirements for inclusion. The following conditions were grounds for exclusion: multiple teeth experiencing active pain; contraindications to using any NSAIDs or opioids as part of the local anaesthetic solutions; teeth having anatomic deviations or periodontally damaged teeth; and patients who were pregnant or nursing. The diagnosis and evaluation of inclusion/ exclusion criteria were made by a trained clinician, not involved in the actual clinical trial.

For purposes of ruling out any sensitivity to the injection solutions (2% lidocaine with epinephrine and tramadol hydrochloride), an intracutaneous examination was performed on each of the enrolled individuals. Using an insulin syringe, the diluted solutions (1/10) were injected into the forearm's extensor surface. Visual inspection of the injection site was done to rule out erythema or redness. The first step in the trial was to administer an IANB containing 1.8 mL of 2% lidocaine and 1:80,000 adrenaline. The local anaesthetic solution was gradually administered for more than two minutes following negative suction in both planes. Following ten minutes, the patients' perceived level of lip numbness was assessed. When lip numbness did not occur, the blockage was deemed "missed," and the individual was not included.

Individuals who missed blocks received a new injection of IANB and the data was not included in the final analysis. Patients reporting profound lip numbness again received electric and thermal pulp sensibility tests. When there was a positive response, the anaesthesia was deemed to have "failed," and the information was recorded as such. Beneath a rubber barrier, endodontic access cavity preparation was administered to patients who did not respond well. The individual undergoing surgery was instructed to record any pain they felt while the procedure on the 170mm-long Heft Parker Visual Analoge Scale (HP VAS). Six categories—faint, weak, mild, moderate, severe, and intense—are represented by a line that is 170 mm length on the HP VAS. The patient uses signals from the pain scale's divisions to indicate their level of pain. The anaesthesia was deemed unsuccessful if the patient experienced pain greater than mild pain, which was defined as more than 54 mm on the HP VAS.

Statistical Analysis

Utilising Sigma-Stat 3.1 software, a one-way analysis of variance and appropriate post-hoc tests were used to examine the patients' ages and heart rates. The categorical data on gender, teeth kind, and anaesthetic outcomes were analysed using the Pearson chi-square test at 95% significance.

RESULTS:

38 individuals had effective initial inferior alveolar nerve blocks (48 out of 153 clients, or 31% success rate). One of the three intraligamentary injections was administered to the last 105 patients. Table 1 displays the demographic information (ages, sex, and teeth form).

 

TABLE 1-Comparison of age, gender, type of tooth, and success rates

 

2% lidocaine

Tramadol hydrochloride

2% lidocaine plus Tramadol hydrochloride

p

Age

28 years±12 years,

range- 18–59 years

26 years±11 years,

range- 19–54 years

29 years±12 years,

0.66

range- 18–57 years

Gender

21 males

23 males

19 males

0.45, χ2=1.56,

df=2

14 females

12 females

18 females

Type of tooth

First molar=28

First molar=27

First molar=29

0.8, χ2=0.3, df=2

Second

molar=7

Second molar=8

Second molar=6

Successful anesthesia

19 out of 35 patients (54%)

4 out of 35 patients

(11%)

28 out of 35 patients

(80%)

<0.001, χ2=

33.6, df=2

There was no significant difference between age, gender, and type of teeth. There were significant differences between the anesthetic success rates. df: Degrees of freedom

 

TABLE 2-Group-wise comparison of the anesthetic success rates

 

vs.

The difference in success rates

p

95% confidence

intervals of difference in success rates

Chi-square,

degree of freedom X2, df)

2% lidocaine

Tramadol hydrochloride

43%

p=0.0001

21% to 60%

14.5, 1

 

2% lidocaine plus Tramadol hydrochloride

26%

p=0.02

4% to 45%

5.3, 1

Tramadol hydrochloride

2% lidocaine plus

Tramadol hydrochloride

69%

p<0.0001

47% to 81%

33, 1

 

TABLE 3-Pair-wise comparison of the maximum heart rates

 

 

95% CI

Significance values

Difference In heartrates

Lower bound

Upper bound

T score, p

2% lidocaine vs Tramadol hydrochloride

9

3.7

14.3

T=3.4 p=0.001

Significant

2% lidocaine vs 2% lidocaine plus Tramadol hydrochloride

1

–6.6

4.7

T=0.34 p=0.7

Non-significant

Tramadol hydrochloride vs 2% lidocaine plus Tramadol hydrochloride

–8

–13.3

–2.7

T=3 p=0.0035

Significant

CI: Confidence intervals

DISCUSSION

Additional intraligamentary injections with alternative solutions were administered to the patients whose original IANB failed. Eighty percent of the intraligamentary injections containing two percent lidocaine with tramadol were successful. This is a notable increase over the use of two percent lidocaine or tramadol hydrochloride individually. With a dual mechanism of action involving both opioid and non-opioid effects, tramadol is a synthetic, mild opioid analgesic. Due to its the two types of tramadol (+) and (-), there is a twofold mechanism. Tramadol (+) is converted to (+)-O-desmethyl- tramadol (M1). By blocking the release of nociceptive neurotransmitters via selective mu-receptors, (+) tramadol and its metabolite exhibit central opiate agonist properties.9 The selective mu affinity of the metabolite is much higher than the parent (+) tramadol.9,10In addition, the (+) tramadol prevents serotonin from being reabsorbed. Tramadol with a (-) stymies nor-epinephrine absorption. The combined effect of both enantiomers prevents the diffusion of central pain. Tramadol has demonstrated local anaesthetic effects in addition to its central analgesic effects. Its primary processes are unrelated to this attribute, though. When injected locally, it has both analgesia and anaesthetic effects.10

Tramadol's efficacy as a local anaesthetic during small procedures, such as lipoma excision or scar revision, was assessed in a research.11 Prior surgery, the patients were randomised to receive subcutaneous injections of either 2% lidocaine or 2 mg/kg tramadol. The researchers listed two benefits for the tramadol group: first, it has lidocaine-like local anaesthetic qualities; second, it lessens the need for analgesics after surgery. Furthermore, it was recently demonstrated that tramadol can lengthen the time that an articaine injectable works.11 An additional investigation assessed the impact of incorporating tramadol into bupivacaine solution while brachial plexus block in the axilla. When 100 mg of tramadol is added to 0.25% bupivacaine, it has been observed to have a faster onset and longer duration than when 0.25% bupivacaine is administered alone.12 In the field of dental care, the local efficacy of tramadol has been mainly evaluated during oral surgical procedures. The authors reported similar results with both injections.

An further investigation assessed the dissemination of intraligamentary injections in mandibular and maxillary teeth.13 The researchers discovered a widespread palatine vascular expansion in the anterior and superior labial palatine arteries following maxillary intraligamentary injection. Additionally, expansion was seen to the larger palatine and sphenopalatine arteries. The mandibular teeth exhibited a quick filling of crestal vessels, interdental spaces, and trabecular spaces, as well as a spread into the inferior alveolar and incisive vascular bundle. Contrary to simple dispersion, the researchers determined that intraligamentary injections result in absorption in the vascular bundle. Vasoconstrictors are given to delay the absorption of local anaesthetic drugs. By affecting the adrenergic receptors and constricting the nearby blood arteries, they function as a chemical tourniquet. The presence of vasoconstrictors has been shown to affect the duration of intraligamentary injections.14

CONCLUSION

The addition of tramadol hydrochloride to 2% lidocaine with 1:80,000 epinephrine, given as supplementary intraligamentary injection, can improve the anesthetic success rates.

REFERENCES
  1. Hawkins J.M., Moore P.A. Local anesthesia: advances in agents and techniques.  Clin. North. Am. 2002;46(4):719–32.
  2. Singh P. An emphasis on the wide usage and important role of local anesthesia in dentistry: A strategic review.  Res. J. (Isfahan) 2012;9(2):127.
  3. Eggleston S.T., Lush L.W. Understanding allergic reactions to local anaesthetics.  Pharmacother. 1996;30:851–7.
  4. Rood J. Adverse reaction to dental local anaesthetic injection–'allergy' is not the cause.  Dent. J. 2000;189(7):380–4.
  5. Daubländer M., Müller R., Lipp M.D. The incidence of complications associated with local anesthesia in dentistry.  Prog. 1997;44:132–41. 
  6. Kaufman E., Goharian S., Katz Y. Adverse reactions triggered by dental local anaesthetics: a clinical survey.  Prog. 2000;47:134–8. 
  7. Pang WW, Mok MS, Chang DP, Huang MH. Local anesthetic effect of tramadol, metoclopramide, and lidocaine following intradermal injection. Reg Anesth Pain Med. 1998;23(6):580–3.
  8. Bigham AS, Habibian S, Ghasemian F, Layeghi S. Caudal epidural injection of lidocaine, tramadol, and lidocaine-tramadol for epidural anesthesia in cattle. J Vet Pharmacol Ther. 2010;33(5):439–43.
  9. Grond S, Sablotzki A. Clinical pharmacology of tramadol. Clin Pharmacokinet. 2004;43(13):879–923.
  10. Lassen D, Damkier P, Brøsen K. The pharmacogenetics of tramadol. Clin Pharmacokinet. 2015;54(8):825–36.
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