Efficacy Of Magnesium Sulphate Versus Ketamine as an Adjuvant to Bupivacaine in Pectoral Nerve Block During Mastectomy : Comparative Controlled , Randomized Double-Blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The postoperative time to first request of analgesia
研究概览
简要总结
There are no published article that compare magnesium sulfate and ketamine as adjuvants to bupivacaine in PECS block , so the aim of this study is to evaluate the efficacy of Magnesium sulfate versus ketamine when added to local anesthetic ( Bupivacaine) in pectoral nerve block during mastectomy and detect which of these drugs has the more effective analgesic effect and decrease opioid consumption .
详细描述
Breast cancer is the most common malignancy in females, and its incidence increases with increase the age of the patients and it is the most expected cause of death in the world .
Surgery is the main treatment of breast cancer and other treatments include chemotherapy, radiotherapy , hormonal therapy and biological therapy or combination treatment and this depends on the type of the cancer and its stage .
Breast surgery is usually associated with significant postoperative pain. Poorly controlled postoperative pain has a negative physiological and psychological impacts as it is associated with an increase in hospital stay , medical care cost, significant postoperative nausea and vomiting , development of chronic pain syndrome and impaired quality of life .
Several methods have been involved in postoperative pain control including multi modal analgesia using multiple medication with different mechanism of action as intravenous and oral opioids , non-steroidal anti-inflammatory drugs and local anesthetic infiltration also has an important role in pain control .
Regional anesthetic procedures have an effective role in acute pain control as thoracic epidural and thoracic paravertebral block are considered the gold standard procedures for postoperative pain management for breast cancer surgery, but not every anesthesiologist is comfortable making these invasive procedures .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
this is a randomized double-blinded study All patients included will be divided randomly into three groups Preoperative data will be recorded by anesthesiologist who will be blinded to the study .
The studied drugs will be prepared by anesthetist ( who will be blinded to the study and will not involved in the technique) in labeled syringes .
Randomization will be done using a computer-generated sequence. The randomly assigned numbers in each group will be hidden in sealed and opaque envelopes
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient
- •Age from 30 to 70 years old
- •American Society of Anesthesiologists (ASA) I-II
排除标准
- •Cognitive impairment
- •History of alcohol or drug abuse
- •Allergy to the studied drugs
- •Patients with coagulation disorders
- •Block site infection
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension
- •Body Mass Index( BMI) more than 30 kg/m2
研究组 & 干预措施
Group A (control group )
Patients will be given 30 mL of 0.25% bupivacaine hydrochloride in pectoral nerve block .
干预措施: Use of Bupivacaine in pectoral nerve block in mastectomy (Drug)
Group B ( Ketamine group)
Patients will be given 30 mL of 0.25% bupivacaine hydrochloride plus ketamine hydrochloride (1 mg/kg) in pectoral nerve block .
干预措施: use of Ketamine as adjuvants to bupivacaine in pectoral nerve block in mastectomy (Drug)
Group C (Magnesium sulfate group)
Patients will be given 30 mL 0.25% bupivacaine hydrochloride plus magnesium sulfate ( 28 ml bupivacaine 0.25% plus 2ml magnesium sulfate (50%) in pectoral nerve block
干预措施: Use of Magnesium Sulfate as adjuvants to bupivacaine in pectoral nerve block in mastectomy (Drug)
结局指标
主要结局
The postoperative time to first request of analgesia
时间窗: up to 24 hours
the aim of this study is to evaluate the efficacy of Magnesium sulfate versus ketamine when added to local anesthetic (Bupivacaine) in pectoral nerve block during mastectomy and the first time of request of analgesia postoperative in hours is the primary outcome
次要结局
- Visual Analogue Scale (VAS) , the scale is determined by measuring the distance in millimeter (mm) on the 10 centimeter (cm) line between the 0 (no pain ) and the mark of the patient .(up to 24 hours)
- Postoperative analgesic requirements( (pethidine in milligram/ kilogram (mg/kg) )(up to 24 hours)
- Postoperative heart rate (Beat/minute)(up to 24 hours)
- Postoperative non invasive mean arterial blood pressure in millimeters of mercury (mmHg)(up to 24 hours)
- Postoperative respiratory rate (breath /minute )(Up to 24 hours)
- Postoperative Nausea and Vomiting(Up to 24 hours)
研究者
Doaa Moaz Sayem,MD
Lecturer of Anaesthesia, Department of anaesthesia, Surgical Intensive Care Unit and Pain Management Faculty of Medicine ,Beni-Suef university
Beni-Suef University