Comparison between 0.25% Levobupivacaine and 0.25% Levobupivacaine with Clonidine in erector spinae plane block in patients undergoing open cholecystectomy: A prospective randomized double blinded study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the effect of levobupavacaine only and levobupivacaine with clonidine in erector spinae plane block for post operative anaigesia in patients undergoing open cholesystectomy.Using clonidine as adjuvant may increase the period of postoperative analgesia.
研究概览
简要总结
PROPOSED TOPIC OF RESEARCH:
COMPARISON BETWEEN 0.25%LEVOBUPIVACAINE AND 0.25% LEVOBUPIVACAINE WITH CLONIDINE INERECTOR SPINAE PLANE BLOCK IN PATIENTS UNDERGOING OPENCHOLECYSTECTOMY: A PROSPECTIVE RANDOMIZED DOUBLE BLINDEDSTUDY.
OBJECTIVE OF PROPOSED RESEARCH:
Comparison between duration and dosageof post-operative analgesia in first 24 hours with 0.25% levobupivacaine with and withoutclonidine in erector spinae block in open cholecystectomy.
BACKGROUND OF PRESENT STUDY:
Patients undergoing elective opencholecystectomy under general anesthesia, experience varying degrees of pain and discomfortat the site of surgery during post-operative period despite of using systemic opioid andnonopioid analgesics. Post-operative subcostal pain impairs respiratory dynamics resulting inpostoperative respiratory complications. So, patients usually require supplementation of localanaesthetic in various methods like local infiltration, intercostals nerve block etc. to decreasepost-operative pain and discomfort in addition to general anaesthesia. The erector spinaeplane block is a newer regional anaesthetic technique that can be used to provide analgesiafor many surgical procedures or to manage acute or chronic pain.
METHODOLOGY:
This is a hospital based, double blinded, prospective, randomizedstudy on patients posted for open cholecystectomy under general anaesthesia with 0.25 %levobupivacaine as an agent for erector spinae plane block with or without clonidine as anadjuvant in surgical operating rooms and post-operative ward of the general surgerydepartment of Midnapore Medical College & Hospital, Paschim Medinipur for a period of 12months.
EXPECTED OUTCOME:
Erector spinae plane block will increase the duration ofpost-operative analgesia and reduce the use of post-operative analgesic drugs. Weexpect patients receiving clonidine as adjuvant with levobupivacaine (group B) will havea longer duration post-operative analgesia compared to patients receiving onlylevobupivacaine (group A)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status grade I grade II 2) Age group between 18-60 years of both sexs 3) Body Mass Index between 18.5 and 24 4) Patients scheduled for elective open cholecystectomy surgery.
排除标准
- •Patients with severe cardio-respiratory disease 2)Patients with hepatic and renal disease 3)Patients with neurologic disorder 4)Patients with endocrine disorder 5)Patients with psychiartic problem 6)Thyroid disease 7)Diabetes mellitus 8)Pregnancy 9) Drug allergy to study drugs.
结局指标
主要结局
To compare the effect of levobupavacaine only and levobupivacaine with clonidine in erector spinae plane block for post operative anaigesia in patients undergoing open cholesystectomy.Using clonidine as adjuvant may increase the period of postoperative analgesia.
时间窗: The quality of post operative analgesia will be assessed by using VAS at 15 min, 30 min and thereafter every 30 minutes till patient complains of VAS more than 4.Inj pentazocin 0.5 mg/kg will be administered intramuscularly when patients complains of VAS more than 4. If pain is not relieved 45 mins after pentazocin then 75 mg of diclofenac sodium will be administered intramuscularly as rescue analgesia.Total dose of analgesic drug will be calculated for first 24 hrs of after surgery.
次要结局
- to find out total amount of analgesic drugs used by patient in postoperative period in first 24 hrs.(VAS score will be assessed at 15 mins, 30 mins and thereafter every 30 minutes till the VAS score becoms more than 4.then toatl amount of analgesics drugs will be calculated in first 24 hrs after completion of surgery.)