Comparison of the efficacy and safety of Transdermal Fentanyl Versus Transdermal Buprenorphine for prevention of Chronic Persistent Post Surgical Pain in Head and Neck Cancer Patients : A Randomized, Single-Blinded, Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving NRS-pain score ≤3/10
研究概览
简要总结
This study is proposed to be a one site prospective randomized study where the study participants will be divided by random allocation into two groups, one will receive treatment with TDF and one group will receive TDB pain patch application. After establishing a diagnosis of HNC, baseline assessment shall be done for pain and quality of life. After the initiation of treatment with transdermal pain patches the participants will be followed up for a period of 3 months at the designated time intervals i.e. at the end of 1st week, 2nd week, 4th week, 6th week, 8th week and 12th week. Two ml venous blood samples shall be collected from all the participants. Two such samples will be obtained as baseline and then at 12th week i.e. post commencement of the treatment with TDF and TDB. Gene expression study will be done by utilizing the real time quantitative PCR, mRNA expression of IL-6 and mTORC1 genes shall be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Operated case of Head and Neck cancer, managed with Standard Postoperative Pain Management Protocol, for initial five days of post-operative period with Pain intensity ≥ 4/10 of Numerical Rating Scale-pain scale on post-operative day 6.
排除标准
- •â€¢Evidence of other sources of pain that may confound the diagnosis •Recent history of any other surgery other than that for HNC •Patients with past H/o MI, DM, pancreatitis and vasculitis.
- •â€¢Patients with evidence of hepatic or renal impairment.
- •â€¢Patients having allergy/intolerance to oral/parenteral/transdermal patches.
结局指标
主要结局
Proportion of patients achieving NRS-pain score ≤3/10
时间窗: Proportion of patients achieving NRS-pain score ≤3/10
次要结局
- Comparison of PDQ(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Comparison of NPSI Score(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Comparison of GPE Score(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Comparison of PDI Score(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Comparison of SF-12 score(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Modulation in mRNA expressions of IL-6 and mTORC1 genes(Pre-treatment and at the end of 12th week post treatment)