Comparative study of preoperative oral pregabalin alone,pregabalin with dexamethasone and pregabalin with Vitamin B complex for postoperative analgesic requirement in open inguinal hernia repair under subarachanoid block.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Primary outcome will be to compare efficacy of drug combinations in prevention of postoperative pain .
研究概览
简要总结
PROJECT SUMMARY: Prevention and treatment of postoperative pain continues to be a major concern in postoperative care and plays an important role in the early mobilization and well being of the surgical patient.Postoperative pain due to tissue injury and surgical trauma is associated with neuroendocrine stress responses, catecholamine,inflammatory mediator release, and central sensitization,which is considered to be one of the mechanisms responsible for the persistence of postoperative pain.Preventing central sensitization with multimodal analgesicinterventions could reduce the intensity or even eliminate acutepostoperative pain hyperalgesia and chronic pain after surgery.Role of pregabalinhas been established in literature for postoperative pain other than neuropathic painwith good results.[3,4] On the other hand Dexamethasone is known to have some analgesic,antiemetic properties but its efficacy as an adjuvant analgesic for postoperative pain in cases under spinal anaesthesia is not studied extensively. Recently few studies have shown the role of Vitamin B complex in Acute pain although there is limited literature supporting its adjuvant analgesic role for postoperative pain.However there is paucity of studies in comparison with pregabalin alone with dexamethasone and pregabalin with vitamin B complex for postoperative pain. This study is designed to compare their efficacy with respect to increase in duration of analgesia, reduction in total post- operative requirements of analgesics and study side effects and complications in Three groups.One twentysix patients of either sex in ASA grade I and II were randomly allocated to one of the three groups of fortytwo each. The patients in Group I will be given single dose of oral capsulePregabalin 300mg with IV Placebo in 100ml NS( over 15 minutes) one hour prior to administration of spinal anaesthesia in patient of Open Inguinal hernia repair.Group II will be administered oral capsule Pregabalin 300mg with IV Inj Dexamethasone 8 mg in 100ml NS( over 15 minutes) one hour prior to administration of spinal anaesthesia in patient of open inguinal hernia repair.Group III will be administered oral capsule Pregabalin 300 mg with Inj VitaminB complex(Inj Thiamine 1gm, pyridoxine hydrocloride 1gm,Cyanocobalamine 100mcg,Dexpanthenol 15mg) in 100ml NS( over 15 minutes, close watch for hypersensitivity reaction for 5 minutes,if present stop infusion and noted )one hour prior to administration of spinal anaesthesia in patient of open inguinal hernia repair. The patients will be observed periopeatively for variations in haemodyanamic parameters, sedation scores and incidence of adverse effects among the groups.Postoperatively pain was assessed by Visual Analogue Scale immediate postoperatively and upto 24 hours thereafter. Time since spinal anaesthesia to first dose of analgesic and total dose of analgesic in first 24 hours will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient consented for the study Patient of Age Group : 20-60 years Patients with American society of anaesthesiologists I or II Patient of any gender posted for inguinal hernia repair.
排除标准
- •Patients with refusal to enter the study Patients with American society of anaesthesiologists III, IV or V Pregnant females Patient with History of Renal disease Patient with History of seizure or other neurological disorders Patient currently taking Gabapentin or Pregabalin for other medical purpose Patient with known history of allergic reaction to pregabalin from previous use Patients with known history of allergic reaction to vitamin b complex Patients with comorbid diseases like diabetes, hypertension, neurological, psychiatric or neurovascular disorder Patients having absolute contraindication for spinal anaesthesia like raised intracranial pressure, severe hypovolemia, bleeding diathesis and local infection .
结局指标
主要结局
Primary outcome will be to compare efficacy of drug combinations in prevention of postoperative pain .
时间窗: upto 24 hours
次要结局
- Secodary outcome is to compare haemodynamic staus and incidence of side effects.(upto 24 hours)
