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临床试验/CTRI/2024/10/075264
CTRI/2024/10/075264尚未招募4 期

To compare the efficacy of transdermal diclofenac, ketoprofen and lidocaine patch in post operative pain outcome in modified radical mastectomy patients and consumption of opioid in first 24 hours via patient controlled analgesia pump

Swami Rama Himalayan University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月12日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
To compare the numerical rating score (NRS) score between diclofenac, ketoprofen and lidocaine patch groups and to evaluate the post operative 24 hour intravenous fentanyl consumption through Patient controlled analgesia pump

研究概览

简要总结

Breast cancer treatment is multidisciplinary including surgical, hormonal therapy, targeted drug therapy, radiotherapy, chemotherapy and immunotherapy. Modified Radical Mastectomy (MRM) is a procedure in which the entire breast is removed including the skin, nipple, areola and most axillary lymph nodes, except the pectoralis major muscle which is spared. Most common complication in patients undergoing modified radical mastectomy is pain. In 2020 definition of pain has been revised by International Association for Study of Pain (IASP) as “an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage”. Post MRM pain can be Axillary, chest, shoulder and arm pain, which if left untreated can turn into chronic pain. This is described as post mastectomy pain syndrome (PMPS). Persistent pain in post operative period affects 20-50% of mastectomy patients which in turn affects quality of life of the patient thereafter. Pathophysiology of pain is mainly unrelieved inflammation. Reducing post operative pain can improve the quality of life for which different pain modalities can be used including intravenous (iv) opioids, non-steroidal anti inflammatory drugs (NSAIDS), antiepileptics, antidepressants, blocks. Regional nerve blocks show good efficacy in pain management but the availability of ultrasound limits the use of blocks. Opioid induced hyperalgesia is a sensitisation process whereby opioids, paradoxically causes increased pain sensitivity. In recent advances for multimodal analgesia, opioid free analgesia is produced to avoid opioid related side effects. Non opioid analgesics include NSAIDS, Selective Serotonin reuptake inhibitors, Tricyclic antidepressants, Salicylates, etc .Transdermal drug delivery system is painless method of delivering drugs systematically by applying a drug formulation onto intact and healthy skin. The drug initially penetrates through the stratum corneum and then passes through the deeper epidermis and dermis without drug accumulation in the dermal layer. When drug reaches the dermal layer, it becomes available for systemic absorption via the dermal microcirculation. This route has many advantages including non invasiveness, ease of access and the pharmacokinetics of the drug is more uniform, thus minimizing the risk of toxic side effects. Transdermal drugs bypass the first-pass metabolism of the liver, protecting it from damage

By the end of study we will be able to find out the efficacy of lignocaine patch for post operative pain management in modified radical mastectomy patients.

研究设计

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

入排标准

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

入选标准

  • Patients undergoing modified radical mastectomy Patients giving written consent ASA 1, 2 and 3.

排除标准

  • Patients operated for benign breast disease Patients undergoing repeat surgery or reconstructive breast surgery Allergic to Diclofenac, Ketoprofen or Lignocaine or any other drug used in the study.

结局指标

主要结局

To compare the numerical rating score (NRS) score between diclofenac, ketoprofen and lidocaine patch groups and to evaluate the post operative 24 hour intravenous fentanyl consumption through Patient controlled analgesia pump

时间窗: 1 hour pre induction to 24 hour post operative

次要结局

  • To evaluate and document the complications and side effects of diclofenac, ketoprofen and lidocaine patch for post operative analgesia for 24 hours.(1 hour pre induction to 24 hour post operative)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sonali Mittal

Swami Rama Himalayan University

研究点 (1)

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