A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 239
- 主要终点
- Pain Score
研究概览
简要总结
This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.
详细描述
A key component of the multimodal approach to pain management is the intra-operative surgical site injection of a local anesthetic or drug cocktail. There are many formulations used for this purpose. A formulation documented in the literature was implemented by this institution which has dropped the average length of stay dramatically. Concern over the limited half-life of the administered anesthetic and the continued need for opioid administration has led to a search for better drug formulations and administration vehicles. Recently, the FDA approval of an extended release bupivacaine called liposomal bupivacaine was thought to extend the effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia. Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its recent approval and has been an integral part of the "same day total joint" movement.
Studies have suggested improvement in pain control and shortened hospitalizations with the use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of this agent. Recently a randomized double blind study was performed with total knees which demonstrated no improvement in pain management with the addition of liposomal bupivacaine to the multimodal pain management protocol. This study has not been performed in the hip arthroplasty population.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)
排除标准
- •Current use of opioid drugs
- •Revision surgery
- •Surgical complication (femoral fracture with implant insertion)
- •Inability to provide Informed Consent
研究组 & 干预措施
Hip Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Liposomal Bupivacaine (Drug)
Hip Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Bupivacaine (Drug)
Hip Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Clonidine (Drug)
Hip Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Ketorolac (Drug)
Hip Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Epinephrine (Drug)
Hip Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
干预措施: Ropivacaine (Drug)
Hip Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
干预措施: Clonidine (Drug)
Hip Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
干预措施: Ketorolac (Drug)
Hip Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
干预措施: Epinephrine (Drug)
Knee Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Liposomal Bupivacaine (Drug)
Knee Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Bupivacaine (Drug)
Knee Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Clonidine (Drug)
Knee Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Ketorolac (Drug)
Knee Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
干预措施: Epinephrine (Drug)
Knee Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
干预措施: Ropivacaine (Drug)
Knee Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
干预措施: Clonidine (Drug)
Knee Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
干预措施: Ketorolac (Drug)
Knee Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
干预措施: Epinephrine (Drug)
结局指标
主要结局
Pain Score
时间窗: Starting post operatively and then every four hours up to 48 hours
Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated.
次要结局
- Narcotic Consumption(Starting immediately post operatively up to 48 hours)
- Length of Stay(Start of surgery to hospital discharge up to 140 hours)
