NCT04850885

Efficacy of Dexamethasone or Adrenaline in Inferior Alveolar Nerve Block

Completed Phase 3 Last updated 22 April 2021

What this trial tests

Phase 3 trial testing inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml in Oral Surgical Procedure in 83 participants. Completed in 28 February 2021.

Timeline

1 August 2020

Primary endpoint
2 February 2021

28 February 2021

Quick facts

Lead sponsor	Tribhuvan University, Nepal
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	83
Start date	1 August 2020
Primary completion	2 February 2021
Estimated completion	28 February 2021
Sites	1 location across Nepal

Drugs / interventions tested

• inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml — full drug profile →

Conditions studied

• Oral Surgical Procedure — all drugs for Oral Surgical Procedure →

Sponsor

Tribhuvan University, Nepal

Who can join

Adults 18 to 60, any sex, with Oral Surgical Procedure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of dexamethasone or adrenaline with lignocaine 2% for prolonging inferior alveolar nerve block: a randomized controlled trial.
   Deo SP, Ahmad MS, Singh A. · · 2022 · cited 5× · PMID 35221304 · DOI 10.5125/jkaoms.2022.48.1.21