Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Unilateral Total Knee Arthroplasty- A Randomised, Double Blind, Active Control, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Efficacy and safety of pregabalin and tapentadol by measuring the mean difference in the mean VAS score.
研究概览
简要总结
Preemptive analgesia is a treatment modality which starts even before the surgery, so that the central sensitization is prevented due to incisional injury at the time of surgery, so it covers the period of surgery and initial post-operative period preventing the development of central sensitization.
Gabapentinoid compounds are gabapentin and pregabalin which have been extensively used in seizure disorder patient. Role of gabapentinoid compounds in the management of pain, as a pre-emptive analgesia is yet to be completely evaluated in post operative pain. Opioids have always been the preferred drugs to manage post operative pain. Since opioids have major side effects of nausea vomiting associated with its treatment their use comes with management of these side effects.
Currently, diagnostic and therapeutic approaches to manage pain experienced by individuals are limited especially because there's a lack of bio-markers predictive of therapeutic outcome. In search of an objective method for pain measurement, as pain has always been subjective and it is perceived by different people differently the study will also include finding the use of COX(cyclo-oxygenase)-2 as a bio-marker of pain in post-operative patients.
Although several randomized clinical trials and met-analyses have been conducted comparing the safety and efficacy of tapentadol or pregabalin in post-operative pain, there is no head to head clinical trial conducted comparing the preemptive use of two drugs for postoperative pain following total knee arthroplasty (TKA). Hence the present study is planned.
详细描述
MATERIALS AND METHODS
After approval of the institutional Ethics committee board, written informed consent will be taken from all the eligible and willing patients.
A. Study design: Randomized double blind active controlled parallel group noninferiority clinical trial.
B. Randomization: A variable block randomization. The allocation ratio will be 1:1 ratio between two interventions arms i.e. tapentadol 100 mg(milligram) and pregabalin 150 mg(milligram) orally.
C. Allocation concealment: This study will be participant and investigator blinded. Allocation concealment will be done by sequentially numbered sealed drug pouches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study will be participant and investigator blinded. Allocation concealment will be done by sequentially numbered sealed drug pouches.
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 both males and females undergoing total knee arthroplasty surgery.
- •Patients are capable of providing an informed consent.
- •Age group between 18-75 years.
排除标准
- •1.Patients with asthma, COPD or any other respiratory disease.
- •Persistent nausea and vomiting at time of randomization
- •Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re-uptake inhibitors, gabapentinoids.
- •Patient with known neurological/ neuropsychiatric disorders.
- •Drug or alcohol abuse history
- •Opioid tolerance or opioid dependence.
- •Known history of opioid allergy or pregabalin allergy.
- •Renal disease (creatinine >1.5mg/dl)
- •Liver disease (total bilirubin >1.5mg/dl)
- •Pregnancy and lactation.
- •Cardiovascular insufficiency.
- •Patient with potential serotonin syndrome.
- •Patient with history of constipation and prone to paralytic ileus.
研究组 & 干预措施
Pregabalin
Pregabalin 150mg oral tablets before one hour before undergoing unilateral total knee arthroplasty
干预措施: Pregabalin 150mg (Drug)
Tapentadol
tapentadol 100mg oral tablets before one hour before undergoing unilateral total knee arthroplasty
干预措施: Tapentadol 100 MG Oral Tablet (Drug)
结局指标
主要结局
Efficacy and safety of pregabalin and tapentadol by measuring the mean difference in the mean VAS score.
时间窗: Evaluated over 24hrs post unilateral total knee arthroplasty
Visual analogue scale (VAS) from 0 to 100 mm score at 0,6,12,24 hrs. post operatively in both the groups.
次要结局
- Measuring the rescue analgesic requirement in both the groups(Recorded over 24hrs post unilateral total knee arthroplasty)
- Percentage of adverse events in a 4-point verbal scale.(Recorded over 24hrs post unilateral total knee arthroplasty)
- Comparing differences in TOTPAR scale through different time points of 24 hours Comparing differences in TOTPAR (none, mild, moderate and severe) scale through different time points of 24 hours(Recorded over 24hrs post unilateral total knee arthroplasty)
- Estimation of COX-2 at 0hrs and 6hrs post operatively in both the groups by ELISA.(In two blood samples one at 0hrs and 6hrs post operatively)
- Monitoring adverse events in both the groups including post-operative nausea vomiting (PONV)(Recorded over 24hrs post unilateral total knee arthroplasty)
- Reduction of VAS and nausea/vomiting(Evaluated at the end of 6 hours and 12 hours without nausea and vomiting)
研究者
Dr Debasish Hota
PROFESSOR AND HEAD OF THE DEPARTMENT PHARMACOLOGY
All India Institute of Medical Sciences, Bhubaneswar