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临床试验/CTRI/2025/07/091857
CTRI/2025/07/091857尚未招募2/3 期

Evaluation of Efficacy of Intrasocket Local Application of Bupivacaine as Add on Pain Control Therapy in Patients Undergoing Surgical Extraction of Mandibular Third Molar: A Randomized Control Clinical Study.

NA1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月8日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
NA
入组人数
120
试验地点
1
主要终点
1. To determine the duration of pain relief obtained after

研究概览

简要总结

The management of post-operative dental pain is imperative to eliminate patient suffering, improve quality of life, and reduce healthcare costs. Post-surgical dental pain is typically treated with orally administered analgesics that block inflammatory mediators (e.g., non-steroidal anti-inflammatory drugs, corticosteroids) or block central mechanisms of pain perception (e.g., opioids).  Although extremely beneficial for managing pain, these orally delivered drugs require continuous self-medication, and hold potential for adverse systemic effects, including sleep disruption, nausea, neurological dysfunction, circulatory/respiratory depression, and addiction.  Alternatively, anaesthetic drugs that block peripheral nerve impulses, such as bupivacaine, are delivered locally to the surgical site, thereby lessening the quantity of necessary postoperative analgesics and mitigating the deleterious effects of oral medications. For instance, a single injection of Bupivacaine results in a maximum plasma drug concentration within 30–45minutes, with complete elimination after 6 hours. Local drug delivery of local anaesthetics may improve dental pain management by prolonging drug effectiveness, and reducing toxicity by slowing drug uptake into systemic circulation. Current approaches to achieve sustained duration of anaesthetic involve co-formulation of drug with a biocompatible polymeric carrier, which controls drug release kinetics. Bupivacaine is an Amide type of Anaesthetic agent and is known for postoperative pain control. According to Stanley F. Malamed The patients requirement for postoperative opiod analgesics is considerably lessened when bupivacaine is administered for pain control. For short surgical procedure (<30 min) Bupivacaine may be administered at the start of procedure following administration of the local anaesthetic chosen for periprocedural pain management. However, for postoperative pain control after lengthy surgical procedures, it is reasonable to administer Bupivacaine at the conclusion of the procedure, just before the patients leave the dental operating chair. 16 Many studies have used Bupivacaine- Soaked gelatin sponges in major surgeries to reduce post operative analgesia. The development and use of local anaesthetics for intraoperative anaesthesia and postoperative analgesia is considered to be one of the most important advances in dentistry in the last century. Talimkhani et al. used the intra-socket administration of bupivacaine with a prepared catheter fixated to a mandibular second molar, with its cannula inserted into the socket of the extracted third molar so that the patients could directly administer drugs (bupivacaine or saline as a placebo) into the tooth socket. bupivacaine significantly relieved postoperative pain after the surgical extraction of Impacted Mandibular Third Molar Surgery. Several researchers have credited bupivacaine with the ability to provide prolonged postoperative analgesia and to minimize analgesic requirements in the early postoperative hours, when pain is at its highest intensity. Its long duration of action and superior ability to decrease pain and discomfort have been reported in comparison with articaine and lidocaine. Therefore, bupivacaine is a common choice for pain control following impacted mandibular third molar extraction. The delivery of a local anaesthetic agent to the postextraction socket has been described to alleviate postoperative pain. However, the use of local delivery therapeutics requires some mechanism to maintain the agent within the oral environment for an adequate period of time to prolong drug effectiveness and reduce its toxicity by slowing drug uptake into the systemic circulation. Few studies have investigated the effect of the local application of bupivacaine in post-extraction sockets 17 following the surgical removal of Impacted mandibular third molar surgery. Therefore, the aim of this study was to assess the effect of the local application of bupivacaine on reducing early postoperative pain following IMTM surgery Therefore, to induce the effects of bupivacaine locally into the extraction socket, Absorbable Gelatin sponge can be used as a vehicle. Absorbable Gelatin sponge is water insoluble, porous sponge prepared from dried and sterilized porcine gelatin. It has very little tissue reaction, liquefies in the socket within a week and fully absorbed within 4 to 6 weeks. It has been used as vehicle to carry medicaments applied to the bleeding site, such as topical thrombin for hemostasis. Locally delivered drug will bypass the undesired toxic systemic adverse effects. The aim of this study is to assess the Effect of Intra-Socket delivery of Bupivacaine in Post Extraction initial Dental Pain.

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

  • Position B (according to Winters classification based on depth for impacted third molar)
  • Healthy patients of age 18 years and above of either gender requiring surgical extraction of impacted mandibular third molars.
  • Patients willing to participate in the study.
  • Anaesthesiologists physical classification level 1 (ASA-1).

排除标准

  • Patients with possible allergies or hypersensitivity to study drug and local anaesthesia and to drugs such as antibiotics and anti-inflammatory drugs.
  • Medically compromised patients such as cardiovascular disease, diabetes mellitus, hepatic disease, blood disorder, GI bleeding or ulceration.
  • Mentally challenged patients, pregnant women and Lactating mothers.
  • Patients on corticosteroid therapy.
  • Patients with reduced mouth opening due to conditions such as oral submucous fibrosis and hypoplastic mandible.

结局指标

主要结局

1. To determine the duration of pain relief obtained after

时间窗: Patients will be evaluated | post administration of drug and to score the overall pain at 4hr, 6hr and 8hr using the VAS

locally administered Bupivacaine.

时间窗: Patients will be evaluated | post administration of drug and to score the overall pain at 4hr, 6hr and 8hr using the VAS

次要结局

  • To quantify the period of administration of an additional(analgesic in the post operative period after locally)

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Dr Shagun Soni

Nair Hospital Dental College

研究点 (1)

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