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Efficacy of Dexamethasone or Adrenaline in Inferior Alveolar Nerve Block

NCT04850885 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2021-04-22

No results posted yet for this study

Summary

Oral and dental professionals were responsible for the discovery of anaesthesia, given their close day-to-day contact with pain and, hence, their motivation to seek the means to alleviate it. Currently, third molar surgery (TMS) has become the model most frequently used in acute pain trials because third molar surgery (TMS) is simple and frequently used procedure with pain moderate or severe in intensity, as well as sufficient numbers of patients, are available for the required sample size for the studies.

Effective local anaesthesia is arguably the single most important pillar upon which modern dentistry stands. Many agents are not available in the markets of Nepal that provide a rapid onset of surgical anaesthesia with adequate duration. The current study is designed to search for a better quality of perioperative analgesics with a single injection of dexamethasone and lignocaine in IANB preoperatively during TMS. The purpose of the current study is to evaluate the effectiveness and safety profiles of coadministration of dexamethasone (4mg/ml) or adrenaline ( 0.01mg/ml) with lignocaine 2% in IANB during TMS. Best of my knowledge this is a unique and novel clinical trial, probably the first trial which aim to overcome three principal challenges of local anaesthesia with a single injection during TMS.

Conditions

  • Oral Surgical Procedure

Interventions

DRUG

inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml

The modified technique of classical IANB was to be selected to avoid failure as described by Clark and Homes (1959). The patients were requested to keep their mouth wide open and an occlusal plane parallel to the floor. Palpation of anatomical landmarks was done properly and the guide finger was positioned at the retromolar fossa. A 5 ml syringe equipped with a 24 gauge needle length of 3.6 cm was used, it was been advanced from premolar on the opposite side into the tissue just above the fingernail until hitting the bone. The body of the syringe was redirected over the lower central incisors and kept parallel to the molars in a horizontal plane at the same time. The needle was inserted another 2 cm deep into the tissue and 3.5 ml of solution X was deposited 1 cm higher than the usual after multiple aspirations (90 degrees two planes). Further, 1 ml solution X was deposited after the withdrawn needle in pterygomandibular space.

Sponsors & Collaborators

  • National Medical College, Birgunj, Nepal

    collaborator UNKNOWN

  • Tribhuvan University, Nepal

    lead OTHER

Principal Investigators

  • Saroj P Deo, 10+2 · Tribhuvan University, Nepal

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-02-02
Completion
2021-02-28

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04850885 on ClinicalTrials.gov