A Prospective study to compare epidural buprenorphine versus epidural tramadol for post operative analgesia in lower limb orthopedic replacement surgeries.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- This observational study will help us to know between epidural buprenorphine and epidural tramadol which drug provides better postoperative analgesia
研究概览
简要总结
A Prospective study to compare epidural buprenorphine versus epidural tramadol for post operative analgesia in lower limb orthopedic replacement surgeries
AIM
The aim of study is to compare post operative analgesic efficacy of epidural tramadol versus epidural buprenorphine in lower limb orthopedic replacement surgery.
OBJECTIVES
· To compare the onset, total duration and quality of analgesia between the groups.
· To compare the haemodynamic changes between the study groups.
**INCLUSION****CRITERIA:**Patient willing to sign the written informed consent.
Patients belonging to American Society of Anaesthesiologists (ASA) Grade I or II
Male or female patients between age range of 18- 60 years.
lPatients undergoing elective lower limb orthopedic replacement surgeries under spinal anaesthesia.
EXCLUSION****CRITERIA:
Patients unwilling to participate in the study.
Patients belonging to ASA Grade III or more.
Pregnant or lactating woman.
History of known allergy to study drug.
Patients having any vertebral anomalies.
Patients who needs supplementation of general anaesthesia.
Any contraindication to Epidural Anaesthesia (local site infection, coagulation disorder, raised intacranial pressure, hemodynamic instability, neurological disorders).
Methods:
The Randomised Prospective Observational Study will be conducted in Department of Anaesthesiology in Dhiraj hospital. After approval from instituitional ethics committee the study will be conducted to compare epidural buprenorphine and epidural tramadol for post operative analgesia in 60 patients undergoing lower limb orthopedic replacement surgeries, aged 18 to 60 years.
Patients will be randomly allocated using computer generated random numbers into two groups: Group B and Group T of 60 patients each.
60 patients will be randomly divided by computer generated random numbers into 2 groups of 30 patients each :
Group B will receive epidurally 100 mcg of buprenorphine diluted with normal saline to make a total volume of 10ml.
Group T will receive epidurally 50mg of tramadol diluted with normal saline to make a total volume of 10ml.
The procedure will be performed by the anaesthesiologist not related to study. All the patients will be explained clearly about the purpose and nature of the study in the language they can understand. They will be included in the study only after obtaining a written informed consent.
Study site: Dhiraj hospital, S.B.K.S. Medical institute and research center, Sumandeep vidyapeeth deemed to be university,piparia,vadodara,Gujarat.
Study design: Randomized Prospective Observational Study
likely outcome of the study:
This prospective and observational study will help us to compare between epidural buprenorphine and epidural tramadol which drug provides superior postoperative analgesia with fewer side effects and is a more effective option for patients undergoing lower limb orthopaedic replacement surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patient willing to sign the written informed consent.
- •Patients belonging to American Society of Anaesthesiologists (ASA)Grade I or II 3)Male or female patients between age range of 18 and 60 years.
- •Patients undergoing elective lower limb orthopedic replacement surgeries under spinal anaesthesia.
排除标准
- •Patients unwilling to participate in the study.
- •Patients belonging to ASA Grade III or more.
- •ï¬ Pregnant or lactating woman.
- •History of known allergy to study drug.
- •Patients having any vertebral anomalies.
- •Patients who needs supplementation of general anaesthesia.
- •Any contraindication to Epidural Anaesthesia (local site infection, coagulation disorder, raised intacranial pressure, hemodynamic instability, neurological disorders).
结局指标
主要结局
This observational study will help us to know between epidural buprenorphine and epidural tramadol which drug provides better postoperative analgesia
时间窗: postoperatively,the study drug will be administered via epidural route when VAS more than equal to 4. | * The VAS before administration of drug is considered as "Base Line". | * VAS is noted immediately after administration of drug | * VAS is noted at 1st, 2nd, 3rd, 4th and so on till 12th hour after the administration of the drug via epidural route.
with minimal side effects in patients undergoing lower limb replacement surgeries.
时间窗: postoperatively,the study drug will be administered via epidural route when VAS more than equal to 4. | * The VAS before administration of drug is considered as "Base Line". | * VAS is noted immediately after administration of drug | * VAS is noted at 1st, 2nd, 3rd, 4th and so on till 12th hour after the administration of the drug via epidural route.
次要结局
- to compare the hemodynamics of the two groups.(vitals will be taken at baseline,15mminutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes.)
研究者
Akashi Shah
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre
