A RANDOMIZED CONTROL STUDY TO EVALUATE THE EFFICACY OF INTRAOPERATIVE LIGNOCAINE INFUSION FOR POST-OPERATIVE PAIN RELIEF IN RENAL TRANSPLANT RECIPIENT PATIENTS.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of intravenous lignocaine at 1.5 mg/kg/hr. in giving adequate post-operative pain relief in renal transplant patients by a combination of numeric pain scale and postoperative fentanyl consumption in comparison to the control group.
研究概览
简要总结
Renal transplants are one of the most performed transplant surgeries. The post-operative pain causes significant morbidity because of the complexity of the transplant surgery and delays the recovery period. These patients often have multiple comorbidities and with poorly controlled postoperative pain, can lead to tachycardia, hypertension, and increased risk of respiratory complications, which can in turn affect overall recovery and graft survival. Among the multimodal pain relief available for these patients, lignocaine has a good margin of safety because of its pharmacodynamics and pharmacokinetics that can make it a good sought-after drug despite the multiple co morbidities present in these patients.
Lignocaine hydrochloride is a local anesthetic agent commonly used for local and topical anesthesia, but it also has antiarrhythmic, and analgesic uses and can be used as an adjunct to tracheal intubation. It is a tertiary amine and is a class Ib antiarrhythmic agent. The anti-nociceptive effects of lignocaine are to be attributable to the blockade of neuronal sodium channels and potassium currents, and the blockade of presynaptic muscarinic and dopamine receptors. They also block sodium and potassium currents centrally at a spinal cord level, specifically targeting the spinal dorsal horn neurons, in addition to their generally accepted peripheral nerve blockade. Lignocaine has potential utility as a potent anti-inflammatory agent. Accumulating data suggests that lignocaine’s powerful anti-inflammatory properties may be superior in many ways to non-steroidal anti-inflammatory drugs and steroids, the traditional anti-inflammatory agents.
With the above discussion, we can hypothesize that, “Intraoperative Lignocaine hydrochloride infusion can be used for providing post-operative pain relief to reduce the opioid consumption†and this study will test the same hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •End stage renal disease patients undergoing recipient of elective live renal transplant surgery
- •male and female
- •ASA 2 and ASA 3 patients.
排除标准
- •Patient refusal
- •Allergic to lignocaine
- •Age less than 18 and more than 65
- •ASA 4 patients
- •Patients undergoing cadaver in renal transplants
- •Uncontrolled Hypertension and Diabetes Mellitus
- •Deranged liver function tests
- •NYHA III and IV
- •History of convulsions.
结局指标
主要结局
To evaluate the efficacy of intravenous lignocaine at 1.5 mg/kg/hr. in giving adequate post-operative pain relief in renal transplant patients by a combination of numeric pain scale and postoperative fentanyl consumption in comparison to the control group.
时间窗: Intra operative surgery time and the duration of patient controlled analgesia.
次要结局
- Intra operative hemodynamics, post operative nausea vomiting and recovery.(Post operative recovery time.)
研究者
Sangeetha A
Manipal hospitals