Effect of Perineural Bupivacaine Infusion on Postoperative Opioid Requirement After Major Lower Limb Amputation: An Open-label Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- To determine the decrease in patient’s post-operative opioid requirement in those undergoing major lower limb amputation and receiving continuous perineural infusion of bupivacaine for three days compared to those receiving standard care
研究概览
简要总结
This is a clinical, prospective, randomised, open label, controlled trial in which the primary objective is to determine the decrease in patient’s post-operative opioid requirement in those undergoing major lower limb amputation and receiving continuous perineural infusion of bupivacaine for three days compared to those receiving standard care. Secondary objectives are to determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for postoperative mean pain score assessed using the visual analog scale (VAS) for three days in both groups, incidence of catheter-related complications (brocade, slippage, wound infections), and incidence of Phantom limb pain.
A sample size of 124 is aimed for and recruited patients undergoing major lower limb amputations will be randomised into the control and study groups intra op after identification of the nerve around which perineural catheter is to be placed. Patients in the control group will recieve bupivacaine infusion for 72h post op via the perineural catheter and post op opioid requirements will be assessed for 72h post op. Secondary outcomes will also be assessed. Patients in the control group will be managed according to standard amputation techniques and anaesthesia protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (Age ≥ 18 years) undergoing elective or emergency major lower limb amputations.
排除标准
- •1.Patients undergoing hip disarticulation, and hindquarter amputation.
- •2.Patients who have an allergy to bupivacaine 3.Patients are expected to be requiring sedation or ventilatory support for more than 24 hours.
- •4.Patients undergoing revision amputation who have been previously recruited into the study.
- •5.Patients undergoing bilateral amputations.
- •6.Patients in whom the appropriate nerve could not be identified.
- •8.Patient denying consent.
结局指标
主要结局
To determine the decrease in patient’s post-operative opioid requirement in those undergoing major lower limb amputation and receiving continuous perineural infusion of bupivacaine for three days compared to those receiving standard care
时间窗: Measured every 6h for 72h
次要结局
- To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for postoperative mean pain score assessed using the visual analog scale (VAS) for three days in both groups.
- To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for incidence of catheter-related complications (brocade, slippage, wound infections).
- To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for incidence of Phantom limb pain(3 months post op)