跳至主要内容
临床试验/CTRI/2026/04/107927
CTRI/2026/04/107927尚未招募4 期

Comparative evaluation of anaesthetic efficacy of 0.5 percentage bupivacaine with oral diclofenac potassium vs 0.5 percentage bupivacaine on inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular first molar A prospective randomized clinical trial

Vivek Manohar Kalluri1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This prospective randomized double blind clinical trial aims to compare the anaesthetic efficacy of 0.5 percent bupivacaine with oral diclofenac potassium versus 0.5 percent bupivacaine alone for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular first molars. A total of 60 patients will be randomly allocated into two groups of 30 each. The experimental group will receive a single oral dose of 50 mg diclofenac potassium one hour before administration of inferior alveolar nerve block with 0.5 percent bupivacaine. The control group will receive a placebo tablet one hour before administration of inferior alveolar nerve block with 0.5 percent bupivacaine. Pain scores will be recorded using the Heft Parker Visual Analog Scale at four time points before premedication after local anesthesia during access cavity preparation and during first file placement. Successful anaesthesia is defined as no pain or mild pain on the  VAS scale. Patients aged over 18 years with symptomatic irreversible pulpitis in mandibular first molars who have not taken analgesics within six hours will be included. Patients with allergies to diclofenac or bupivacaine bleeding disorders pregnancy or significant medical conditions will be excluded.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Healthy patients over 18 years old with Symptomatic irreversible pulpitis in first mandibular molar tooth Patients who had not taken any analgesics within 6 hours before endodontic treatment.
  • Patient willing to participate.

排除标准

  • History of allergies or sensitivity to Diclofenac Potassium History of known allergies or sensitivity to bupivacaine History of anti-coagulant drug therapy History of central nervous system depressants therapy Pregnant or lactating females, History of active peptic ulcer within the preceding 12 months, Bleeding problems or bleeding disorders Not willing to participate.
  • History of significant medical problems (American Society of Anaesthesiologists class III or higher) History of ventricular arrhythmias, hypotension, hypertension, bradycardia, hemodynamic instability, and cardiovascular collapse.

研究者

发起方
Vivek Manohar Kalluri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vivek Kalluri

Government dental college and hospital mumbai

研究点 (1)

Loading locations...

相似试验