Comparative Evaluation of Peri-operative Analgesic Effect of Lidocaine Combined with Opioid Analgesic in Patients with Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis in Mandibular Molars – A Double Blind Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To comparatively assess the perioperative analgesic efficacy of 75 mcg and 150 mcg of buprenorphine with 2% lignocaine hydrochloride as a local anaesthetic agent in mandibular molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis using heft-parker visual analogue scale.
研究概览
简要总结
| Regardless of the advancements in innovation, the number of people experiencing dental pain remains relatively high. Amongst them, many require endodontic therapy for the relief of pain. Though the procedure prevails upon anxiety in some individuals, literature states that fear of pain and needles, failure of profound anesthesia, and anxiety are the major concerns. |
Profound research has been investigated in endodontic pain management. A survey by the American Association of Endodontists (AAE) found that 67% of patients had fear of pain as their primary concern during endodontic therapy. A study by O¢Keefe stated that patients with moderate to severe preoperative pain are more analogous with intra and postoperatively during endodontic therapy. Pain management in endodontic therapy can be focused on either by blocking or reducing the nociceptive impulses or by preventing pain perception in the central nervous system. Thus, in many of the peripheral nerve block approaches, a short-acting local anesthetic with or without a vasoconstrictor is employed.
Endorphins are endogenous opioids produced naturally to provide analgesic effects. In inflammation, the opioid receptors are increased around the peripheral nerves. If an exogenous opioid is added to the local anesthetic agent to block the peripheral nerve, significant analgesia can be achieved during the procedure and postoperatively.
Buprenorphine is a partial agonist and antagonist opioid with the property of a ceiling effect. It has fewer side effects when compared to full-agonist opioids. An elimination half-life of 24–37 hours provides a significant duration of analgesia without motor or sensory blockade.
Peri-operative pain experienced by patients suffering from pulpitis is a major concern in endodontic therapy. To improve the patient’s compliance with post-operative sequelae, we intended to add Buprenorphine, a narcotic analgesic with a partial agonist and antagonist in action. With this addition to lidocaine, the post-operative analgesic effect can be prolonged.
The present study has chosen to use buprenorphine at two distinct concentrations, along with 2% lignocaine, in order to assess perioperative analgesia. Typically, a dose of 300 mcg of buprenorphine is included with the local anesthetic used in peripheral plexus blocks. Because the inferior alveolar nerve is smaller in diameter and in a highly vascularised area, a lower dose of 75 mcg and 150 mcg with 2% lignocaine will be used in this study.
However, a comprehensive review of the literature observed no studies that revealed the efficacy of mixing buprenorphine hydrochloride with lignocaine hydrochloride as a local anesthetic for endodontic therapy. Moreover, there were no reports comparing this combination of drugs with other local anesthetic agents.
Thus, the aim of this study is to compare the perioperative analgesic effect of buprenorphine hydrochloride combined with lignocaine hydrochloride during the treatment of mandibular molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis.
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 45.00 Year(s)(—)
- 性别
- All
入选标准
- •• ASA I & II • Pain severity with HP-VAS (85-170) Moderate – Severe in mandibular molars.
排除标准
- •• ASA III • Patient consumed any anti-inflammatory drugs 24 hrs before the day of reporting.
- •• Allergic to LA • Pregnant & lactating women • Patients under the influence of alcohol 24 hrs before the procedure.
结局指标
主要结局
To comparatively assess the perioperative analgesic efficacy of 75 mcg and 150 mcg of buprenorphine with 2% lignocaine hydrochloride as a local anaesthetic agent in mandibular molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis using heft-parker visual analogue scale.
时间窗: intraoperative and 6, 12, 24, 48 hrs post operative
次要结局
- Pain experience assessment(intraoperative and 6, 12, 24, 48 hrs post operative)
研究者
Dr Vijay Amirtharaj L
SRM Institute of Science and Technology
