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临床试验/CTRI/2024/11/076797
CTRI/2024/11/076797尚未招募3 期

Effect Of Premedication With Meloxicam on Anaesthetic Efficacy of A Combination of Mannitol Plus LIdocaine With Epinephrine In Inferior Alveolar Nerve Block: A Randomized Control Trial

Dr Shivi Agarwal1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To determine the effect of premedication with meloxicam on the anaesthetic efficacy of a combination of mannitol plus lidocaine with epinephrine in inferior alveolar nerve blocks

研究概览

简要总结

Patients with symptomatic irreversible pulpitis often face significant challenges in achieving effective anesthesia with inferior alveolar nerve (IAN) blocks. Failure rates for IAN blocks in such cases can be as high as 44% to 81%, largely due to the perineural barrier, which restricts the diffusion of anesthetic agents into the nerve trunk. The innermost layer of this barrier, known as the perilemma, acts similarly to the blood-brain barrier, presenting a formidable obstacle to complete anesthetic effectiveness. Inflammation associated with irreversible pulpitis may sometimes disrupt this barrier, temporarily increasing its permeability and improving anesthetic outcomes. However, this effect is unpredictable, prompting research into adjunctive agents that could more consistently enhance anesthesia.

Mannitol, a hyperosmolar sugar alcohol solution, has shown potential in overcoming restrictive barriers like the blood-brain barrier in other medical applications, such as treating cerebral edema. Mannitol works by temporarily increasing the permeability of the perineural membrane, thus potentially allowing more anesthetic to penetrate the nerve trunk. In the context of IAN blocks, mannitol could serve as a valuable addition to lidocaine with epinephrine, making it easier for the anesthetic to reach and affect nerve fibers. Initial studies suggest that when mannitol is used alongside lidocaine, the anesthetic effect may be enhanced, providing better pain control in patients who would otherwise remain sensitive to pain during endodontic procedures.

Additionally, meloxicam, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), offers a promising role as a premedication. Unlike other NSAIDs, meloxicam reduces inflammation with a lower risk of gastrointestinal side effects, making it suitable for short-term preoperative use. In cases of pulpitis, local inflammation exacerbates pain and increases resistance to anesthesia. Meloxicam’s anti-inflammatory effects could help lower this resistance by reducing inflammation around the affected tooth, enhancing the overall depth and duration of anesthesia. Although limited studies have examined meloxicam’s specific effect on dental anesthesia, its potential to support anesthetic efficacy makes it an intriguing option for managing difficult cases of pulpitis.

To accurately assess the combined efficacy of mannitol and meloxicam, the study employs electric pulp testing (EPT) and cavity testing as primary outcome measures. EPT offers an objective way to gauge pulpal anesthesia by measuring the tooth’s response to electric stimuli, while cavity testing directly assesses pain response during the dental procedure. Together, these methods provide a reliable assessment of anesthetic success, reflecting not only numbness but also the absence of pain under challenging conditions.

If successful, this approach could set a new standard for anesthetic protocols in endodontics, particularly for patients with symptomatic irreversible pulpitis who often experience pain despite typical anesthesia signs, such as lip numbness. By enhancing anesthetic effectiveness with mannitol and premedicating with meloxicam, clinicians could achieve a more profound and consistent anesthesia, making dental procedures more comfortable for patients with inflamed pulpal tissue. This innovative protocol has the potential to significantly reduce treatment challenges and improve patient outcomes, providing a promising solution in cases where traditional anesthetic techniques have frequently fallen short.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18-65 years with a vital, painful mandibular posterior tooth and a prolonged response to cold testing.

排除标准

  • AGE OUTSIDE 18-65, ALLERGIES TO SPECIFIC SUBSTANCES,PREGNANCY, SIGNIFICANT MEDICAL CONDITIONS, CERTAIN MEDICATIONS, ACTIVE PATHOSIS AT THE INJECTION SITE, OR INABILITY TO GIVE INFORMED CONSENT.

结局指标

主要结局

To determine the effect of premedication with meloxicam on the anaesthetic efficacy of a combination of mannitol plus lidocaine with epinephrine in inferior alveolar nerve blocks

时间窗: Baseline, 6,12,24,72 hours

次要结局

  • TO ASSESS THE ONSET TIME, DURATION OF ANESTHESIA, AND PATIENT COMFORT(Baseline)

研究者

发起方
Dr Shivi Agarwal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shivi Agarwal

ITS -CDSR, GHAZIABAD

研究点 (1)

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