Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pec 11 Modified Block on Postoperative Pain Control in Patients Undergoing Breast Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The time to first request of analgesic postoperatively
研究概览
简要总结
in our study we are trying to reach to the preferred adjuvant from either ketamine or dexmedetomidine to be added to bupivacaine local anesthetic during pec 11 modified block as regard its efficacy and duration of postoperative analgesia it can maintain after modified radical mastectomy surgery so as to achieve better control of postoperative pain than using local anesthetic alone.
详细描述
- Type of Study: Randomized controlled trials
- Study Setting: Operating theater of Ain Shams University Hospitals, Cairo, Egypt
- Study Period: 6 months .
- Sampling Method:
Patients will be subdivided randomly into 3 groups :
Group (PC): will receive 30 ml of 0.25%bupivacaine plus 2ml normal saline. Group (PK): will receive 30 ml of 0.25% bupivacaine added to ketamine hydrochloride
1mg/kg diluted in 2ml normal saline. Group(PD): will receive 30 ml of 0.25%bupivacaine added to dexmedetomidine 1ug/kg diluted in 2 ml normal saline. Study Procedure Following local university ethical committee approval, informed consent will be obtained. Details of the anesthetic technique and the study protocol will be fully explained at the preoperative visit, and written consent will be obtained from each patient before inclusion in the study.
In the pre-induction room the patients will be taught how to assess their own pain score using the numerical rating scale (NRS) (0-10; 0 = no pain, 10 = worst imaginable pain) and how to use the device for a patient-controlled analgesia (PCA) .Patients in all groups will receive 5mg oral midazolam ,2 hours prior to surgery.A20 gauge IV cannula will be inserted in the upper limb contralateral to the side of surgery upon reaching the operating room .Before induction of anesthesia electrocardiography (ECG), non-invasive blood pressure (NIBP), arterial oxygen saturation (Sao2), and end-tidal carbon dioxide (EtCo2) will connected to the patient. In all groups general anaesthesia will be induced using 2 μg/kg fentanyl, 2.5mg/kg propofol and 1 mg/kg lidocaine. Endotracheal intubation will be facilitated by 0.5 atracurium and was maintained by 1 MAC sevoflurane in 50% Oxygen /air mixture, and ventilator parameters will be adjusted to maintain normocapnia. The Pecs11 Modified block will be done using in plane approach, an 80 mm needle using linear array ultrasound probe of high frequency (12Hz).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ASA1,11,111 between 18 and 60 years scheduled for modified radical mastectomy
排除标准
- •Patients with history of advanced cardiac disease
- •Patients having sepsis,
- •Patients with prior surgery in areas above or below the clavicle or in the axillary region,
- •Patients with opioid dependence or alcohol or drug abuse,
- •Patients with coagulopathy
- •Patients with psychiatric illness that prevent them from proper perception and assessment of pain.
结局指标
主要结局
The time to first request of analgesic postoperatively
时间窗: "through study completion ,an average of one year"
time
Total postoperative morphine consumption over the first 24 hours postoperative
时间窗: "through study completion ,an average of one year"
number value
次要结局
- pain scores at rest and active movement of ipsilateral arm("through study completion ,an average of one year")
- intraoperative fentanyl requirements("through study completion ,an average of one year")
研究者
Amira Fathy Hefni,MD-EDIC
Assistant professor
Ain Shams University