A comparative study of post operative pain relief by continuous epidural infusion of Bupivacaine with two different doses of Dexmedetomedine as an adjuvant
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
- 1) HAEMODYNAMIC AND RESPIRATORY PARAMETERS ( BP,PULSE,SPO2,MAP)
研究概览
简要总结
AIM and OBJECTIVES
To compare 0.125% bupivacaine with two different doses of dexmedetomidine (1mcg/kg and 2mcg /kg )as adjuvant for epidural analgesia in surgeries below level of umbilicus ,post operative onset, quality and duration of analgesia, blood pressure, pulse rate, outcome.
MATERIALS AND METHODS
STUDY SITE : ACS MEDICAL COLLEGE AND HOSPITALS, DEPARTMENT ANAESTHESIA
STUDY DESIGN : PROSPECTIVE,RANDOM DOUBLE BLIND HOSPITAL BASED STUDY.
STUDY DURATION: 2 YEARS
MINIMUM SAMPLE SIZE: MINIMUM SAMPLE SIZE IS 100 PATIENTS.
As valuable adjuncts to local anesthetics, ά-2 agonists have sedative properties and analgesic actions at peripheral, spinal and supra spinal levels. Dexmedetomidine - a highly selective ά-2 agonist has been demonstrated to have a strong synergistic action with local anesthetics. Furthermore, when used through the epidural route, Dexmedetomidine has been shown to have numerous beneficial effects.
It acts on both pre and post synaptic sympathetic nerve terminals and on the central nervous system, decreasing sympathetic outflow and norepinephrine release, with consequent sedative, anti-anxiety, analgesic, sympatholytic effects.
Dexmedetomidine causes dose dependent bradycardia, hypotension, so, in this prospective study we have used two different doses that are, 1 and 2 μg/kg along with the
local anesthetic agent bupivacaine to compare their analgesic and
anesthetic efficacy as well as their side effects.
All patients will be anesthetized via epidural route in a double blinded fashion based on a computer generated code to one of the following three treatment groups to receive either
Group 1 :12.5ml bupivacaine (ANAWIN 0.5%) (n=20) (control group)
Group 2 :12.5ml bupivacaine (ANAWIN0.5%) plus 1 μgkg-1 5dexmedetomidine (50μg/ml concentration)(n=20)]
Group 3 : 12.5 ml bupivacaine (ANAWIN 0.5%)plus 2 μg/kg dexmedetomidine { 100mcg/ml concentration)(n=20)].
The anesthetic solution was completed to 50ml using normal saline.
The anesthetic dose will be given in infusion form using infusion pump at infusion rate of 5ml/hr for a period of 24hrs.
Parameters recorded and assessed
onset of analgesia,
duration of the epidural analgesia ,
Mean Arterial Pressure(MAP),
Heart rate,
Visual Analogue Pain Scale(VAS)
Tools used
VAS PAIN SCORE:
VISUAL ANALOGUE SCALE
Used to assess the severity of pain.
0- No pain
1-
2- Mild pain
3-
4- Moderate pain
5-
6- Severe pain
7-
8- Very severe pain
9-
10- Worst possible pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •ALL PATIENTS WILLING FOR STUDY.
- •PATIENTS WITH BOTH GENDERS PATIENTS WHO ARE CONSIOUS AND ORIENTED ALL PATIENTS UNDERGOING SURGERIES BELOW LEVEL OF UMBILICUS ALL PATIENTS UNDER ASA 1, ASA 2, ASA 3 CATEGORIES, ALL PATIENTS UNDERGOING SURGERIES WITH SOLO EPIDURAL PROCEDURE, EPIDURAL WITH SPINAL WITH SPINAL DRUG WITH NO ADJUVANTS ,.
排除标准
- •PATIENTS WHO REFUSE FOR PROSEDURE PREGNANT PATIENTS PATIENTS WITH SPINAL BIRTH DEFECTS,HEMATOLOGICAL CONDITIONS ,HEMOSTATIC DISORDERS OBESE PATIENTS PATIENTS WITH CHRONIC BACK PAIN PSYCHIATRIC PATIENTS UNCONSIOUS,NOT ORIENTED,COMATOSED PATIENTS.
结局指标
主要结局
1) HAEMODYNAMIC AND RESPIRATORY PARAMETERS ( BP,PULSE,SPO2,MAP)
时间窗: 1.at beginning of epidural infusion | 2.at 5 min after first dose | 3.at 10 min after beginning infusion | 4.at 20 min after beginning of infusion | 5.at 1hr after beginning of infusion | 6.at 6hrs after beginning of infusion | 7.at 12 hrs after beginning of infusion | 8.at 24hrs after beginning of infusion
(VAS SCORE 1 TO 10)
时间窗: 1.at beginning of epidural infusion | 2.at 5 min after first dose | 3.at 10 min after beginning infusion | 4.at 20 min after beginning of infusion | 5.at 1hr after beginning of infusion | 6.at 6hrs after beginning of infusion | 7.at 12 hrs after beginning of infusion | 8.at 24hrs after beginning of infusion
2) VISUAL ANALOGUE PAIN SCORE MONITORING DURING PROCEDURE
时间窗: 1.at beginning of epidural infusion | 2.at 5 min after first dose | 3.at 10 min after beginning infusion | 4.at 20 min after beginning of infusion | 5.at 1hr after beginning of infusion | 6.at 6hrs after beginning of infusion | 7.at 12 hrs after beginning of infusion | 8.at 24hrs after beginning of infusion
次要结局
- 1) DOSE OF DRUG AT WHICH PATIENT GETS MAXIMUM PAIN RELIEF.(DURING THE PROCEDURE)