A Comparative Safety and Efficacy Study of Intrathecal Morphine 150 μg with 200 μg Dose for Post-operative Analgesia in Total Knee Replacement Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- •The main outcome
研究概览
简要总结
| Protocol Title |
A Comparative Safety and Efficacy Study of I****ntrathecal M****orphine 150 μg with 200 μg D****ose for Post-operative A****nalgesia in T****otal K****nee R****eplacement Surgeries
|Protocol Short Title
Safety and efficacy of Intrathecal Morphine as an Analgesic in Post-operative Total Knee Replacement
|Acronym
IMDATKR
|Protocol Number
CIMS/2021/001
|Phase of Development
Investigator Initiated Study
|Indication
Use of Morphine in Orthopedic Surgeries like Total Knee Replacement Surgeries as analgesics agent
|Name of Investigational Product
Morphine 150 μg or Morphine 200 μg
|Study Rationale
Total knee replacement (TKR) is a successful surgical approach for the treatment of end-stage knee osteoarthritis in terms of functional recovery and pain relief. This clinical study is designed to compare the intraoperative and postoperative hemodynamic effects, the side effects, the effect on the duration of pain start, the 24-hour VAS and the amount of the morphine, additional analgesia used/added to the local anesthetic in the spinal anesthesia in cases of elective total knee replacement.
|Study Objectives
To determine the safety and efficacy of intrathecal Morphine opiate (narcotic) analgesic agent150 vs 200 μg dose along with other nonsteroidal anti-inflammatory drugs (NSAIDS) agents
|Study Population
The population will consist of approximately 134 males and females with elective primary unilateral TKR
|Study Design
This is an interventional, prospective single-center study to evaluate the safety and efficacy of 2 doses of intrathecal morphine 150 and 200 μg with other nonsteroidal anti-inflammatory drugs (NSAIDS) agent
|Planned No. of Subject
Total 134 Subjects; 67 in Morphine 150 μg arm and other 67 in Morphine 200 μg as a comparative arm
|Planned Duration of Study Participation
Till hospitalization of subjects for TKR surgeries
|Inclusion Criteria
· Elective primary unilateral TKR;
· Patient between the age of 40 to 80
· American Society of Anesthesiologists (ASA) physical status classification 1-3
· BMI less than 40 kg/m2;
· Willing and able to provide written informed consent prior to performing study procedures.
|Exclusion Criteria
- Patients with the history of severe renal and hepatic dysfunction;
- Contraindication to spinal anesthesia (refusal, coagulopathy, sepsis, local infection, spinal defects, previous laminectomy);
- Contraindication to nonsteroidal anti-inflammatory drugs (NSAIDS);
- Patient has an emotional or neurological condition that would prevent their willingness to participate in the study.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
- Creatinine clearance less than 50 ml/min
- Participation in any other clinical trial of an experimental treatment for TKR
|Study Treatment
Group A -Inj. Morphine 150 μg intrathecal with saline along with Inj. Sensorcaine 0.5% heavy (4 ml) (20 mg) intrathecal for Intraoperative anesthesia.
Group B - Inj. Morphine 200 μg intrathecal with saline along with Inj. Sensorcaine 0.5% heavy (4 ml) (20 mg) intrathecal for Intraoperative anesthesia.
|Data Analysis
Descriptive summary statistics (mean, median, standard deviation, minimum and maximum for continuous variables and frequency and percentage for categorical variables)
|Conducted At
Care Institute of Medical Sciences (CIMS Hospital Pvt. Ltd.),
Nr. Shukan Mall, Off Science city Road, Sola, Ahmedabad-380060
|Principal Investigator
Dr. Deepak Desai
|Co- Investigator
Dr. Satish Patel
Dr. Mayank Patel
Dr. Chintan Parekh
Dr. Sandeep Makani
Dr. Mitul Patel
Dr. Ravi Adatiya
|Estimated Duration
1 Year
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Elective primary unilateral TKR; 2.Patient between the age of 40 to 80 3.American Society of Anesthesiologists (ASA) physical status classification 1-3 4.BMI less than 40 kg/m2; 5.Willing and able to provide written informed consent prior to performing study procedures.
排除标准
- •1.Patients with the history of severe renal and hepatic dysfunction; 2.Contraindication to spinal anesthesia (refusal, coagulopathy, sepsis, local infection, spinal defects, previous laminectomy); 3.Contraindication to nonsteroidal antiinflammatory drugs (NSAIDS); 4.Patient has an emotional or neurological condition that would prevent their willingness to participate in the study.
- •5.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment 6.Creatinine clearance less than 50 ml/min 7.Participation in any other clinical trial of an experimental treatment for TKR.
结局指标
主要结局
•The main outcome
时间窗: Until 24 hour of postoperative periods
variables will be
时间窗: Until 24 hour of postoperative periods
consumption amount
时间窗: Until 24 hour of postoperative periods
of opioids (other
时间窗: Until 24 hour of postoperative periods
than morphine) or
时间窗: Until 24 hour of postoperative periods
Diclofenac or
时间窗: Until 24 hour of postoperative periods
Paracetamol in
时间窗: Until 24 hour of postoperative periods
postoperative
时间窗: Until 24 hour of postoperative periods
periods for
时间窗: Until 24 hour of postoperative periods
analgesia within 24
时间窗: Until 24 hour of postoperative periods
hours after the
时间窗: Until 24 hour of postoperative periods
operation.
时间窗: Until 24 hour of postoperative periods
次要结局
- 1. The side effects between group, the length of hospital stay, range of movement, loss of blood collected in dressing / closed suctions.(2. The side effect of intrathecal morphine include nausea, vomiting, retention of urine, itching, constipation, sedation, intraoperative discomfort and respiratory depression.)