Efficacy and safety of preemptive duloxetine and tramadol combination for the control of postoperative pain in patients undergoing unilateral total knee arthroplasty: A randomized, double-blind clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Mean difference in VAS score ( 0 to 100 mm) post operatively in 4 groups
研究概览
简要总结
Despite the availability of multiple analgesic treatment modalities, postoperative pain management is sometimes neglected & under-managed. Also, post-operative high-dose opioids have significant multiple side effects like constipation, paralytic ileus, nausea, vomiting, sedation etc. Prolonged periods of opioid usage for pain management can lead to opioid dependence as well. On the other hand, postoperative long-term NSAID use can lead to renal and hepatic impairment. Thus, there is a dire need for alternative therapeutic options in the management of post-operative pain. The present study has been planned to evaluate the effectiveness of Duloxetine combined with Tapentadol as pre-emptive analgesia in TKA by comparing the pain score, cumulative dosage of opioids, high-sensitivity C-reactive protein (hs-CRP) level, and adverse effects after TKA. We hypothesize that the effectiveness of duloxetine combined with Tapentadol as TKA pre-emptive analgesia would lead to satisfactory clinical outcomes. The primary objective of the present study is to evaluate the effectiveness of Duloxetine combined with Tapentadol as TKA pre-emptive analgesia by compared the pain score, cumulative dosage of opioids, high-sensitivity C-reactive protein (hs-CRP) level, and adverse effects after TKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients both male and females undergoing unilateral total knee arthroplasty surgery.
- •Patients who can provide informed consent 3.Age group between 18-75 years.
排除标准
- •Patients with chronic diseases including asthma, COPD, or any other respiratory disease.
- •Persistent nausea and vomiting at the time of randomization
- •History of seizure
- •Subjects treated with monoamine oxidase inhibitors, tricyclic antidepressants, serotonin-norepinephrine reuptake 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, AST or ALT ≥ 3 times ULN))
- •Pregnancy and lactating women.
- •Cardiovascular insufficiency.
- •Patient with potential serotonin syndrome.
- •Patient with a history of constipation and prone to paralytic ileus.
结局指标
主要结局
Mean difference in VAS score ( 0 to 100 mm) post operatively in 4 groups
时间窗: 0, 24 hour post operatively
次要结局
- 1.To evaluate pain score in visual analog scale (VAS) at 0, 6 & 12 hours postoperatively in patients undergoing TKA
- 2.To evaluate the efficacy of pre-emptive analgesia independent of time points
- 4.Comparing differences in TOTPAR (none, mild, moderate & severe) scale at 0, 6,12, 24 hours post-operatively in both the groups
- 3.Reduction of VAS to 3 or less at the end of 12 hours from 6 hours without nausea & vomiting
- 6.Mean difference in total analgesic consumption in both the groups postoperatively.
- 7. Estimation of plasma hs-CRP at baseline & 6 hours postoperatively in all the groups by ELISA.
- 8. Monitoring treatment-emergent adverse events (TEAE) on a four-point verbal scale in both the groups including post-operative nausea vomiting (PONV).(24 hour post operative)
- 5.Time to first request for rescue analgesia postoperatively