Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty: A Randomized Double Blind Placebo-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Assessment of Change of Pain score compared to plecebo by visual analogue scale
研究概览
简要总结
The study intends to evaluate the efficacy of Tapentadol against placebo as a preemptive analgesic in the management of post-operative pain in the patiens undergoing total knee arthroplasty.
The primary objective is to evaluate th epain score in visual analogue scale at various time points within 24 hours post operarively
详细描述
METHODOLOGY
- Consent: Participants will be explained the benefit and harm of joining the study and the freedom of withdrawing from the study at any moment they would like to. A full voluntary written informed consent will be obtained from each participant. Study will be conducted following the principles of Helsinki after getting written permission of the institutional ethics committee. Before enrolment of first subject in this study registration for clinical trial will be done.
- Participants: Patients of either sex, above 18 yrs. of age undergoing Total Knee Arthroplasty will be the participants in this study.
- Inclusion Criteria:
- Patients both males and females undergoing elective total knee replacement surgery
- Patients are capable to provide an informed consent
- Age 18-75 yrs.
- Exclusion Criteria:
- Patients with Asthma, COPD or any other respiratory disease.
- Persistent nausea and vomiting at the time of randomization.
- Epilepsy.
- Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re uptake inhibitors.
- Patients with ASA grading 3 or more.
- Drug abuse history.
- Opioid tolerance or opioid dependence.
- Renal disease(creatinine>1.5 mg/dl).
- Liver disease (total bilirubin>1.5 mg/dl).
- Known history of opioid allergies.
- Major psychiatric disorder.
- Pregnancy and lactation.
- Emergency surgery.
- Bone tumor
- Migraine patients or patients complaining dizziness, vertigo.
Screening: The trial will be comprised of complete medical history and physical examination and screening. Pre-operative laboratory investigations will be recorded in case record form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex undergoing elective tota knee replacement surgery
- •Patients are capable to provide an informed consent
- •Age 18-65 years
排除标准
- •Patients with Asthma, copd or any other respiratory disease
- •Persistent nausea , vomiting at the time of randomization
- •Treated with MAO inhibitors, Tricyclic antidepressants, SSRIs and SNRIs
- •Patients with ASA grading 3 or more
- •Drug abuse history, opioid tolerance or dependence, known history of opiod allergies
- •Renal or liver disease
- •Major psychiatric disorder
- •Pregnancy and lactation
- •Emergency surgery
- •Bone tumor, epilepsy or patients with migraine
研究组 & 干预措施
Tapentadol arm
Single dose of 100 mg of extended release oral tapentadol will be administered 1 hour before surgery.
干预措施: Tapentadol 100 MG (Drug)
Placebo arm
A comparable placebo will be administered 1 hour before surgery.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Assessment of Change of Pain score compared to plecebo by visual analogue scale
时间窗: 24 hrs. post-operatively( 0,2,4,6,12,24 hrs post operatively)
All the subjects will be assessed for pain at various time points post-operatively by visual analogue scale(VAS) (minimum value 00- no pain to maximum value-100 - worst pain imaginable) Higher values indicate worse outcome
次要结局
未报告次要终点
研究者
Dr Debasish Hota
Prof and Head of the Department
All India Institute of Medical Sciences, Bhubaneswar