Comparative evaluation of Dexmedetomidine versus Dexamethasone as adjuvant to ropivacaine 0.75% in ultrasound guided single shot costotransverse block for analgesia in unilateral breastsurgeries: A Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of dexmedetomidine
研究概览
简要总结
Breast surgery is one of the most commonly performed surgery in women. With the recently introduced Costotransverse block (CTB), this study is designed to establish the postoperative analgesic efficacy of single shot CTB by adding either dexmedetomidine or dexamethasone as adjuvant with ropivacaine.
30 patients will be allocated into each group.
Intervention group 1 (Group CTB-SONE): Patients will receive single shot costotransverse block with 15 ml of 0.75%ropivacaine with 0.1mg/kg dexamethasone to make total volume of 18ml.
Intervention group 2 (Group CTB-DINE): Patients will receive single shot costotransverse block with 15ml of 0.75%ropivacainewith dexmedetomidine 1 mcg/kg to make total volume of 18ml.
On the day of surgery, an intravenous (IV) line will be started at 2ml/kg through 20 G cannula.
Basic monitoring including electrocardiogram, peripheral oxygen saturation (spo2), non-invasive blood pressure (NIBP), heart rate (HR) and capnography (after intubation) will be done.
The block will be given after the induction of anaesthesia and before the start of the surgical procedure.
The same general anaesthesia plan will be applied to all patients in both groups.
Tyhe patient will be induced with propofol (2-3mg/kg), fentanyl (1.5-2ug/kg) followed by vecuronium bromide (0.1ug/kg) to facilitate endotracheal intubatuion.
Anaesthesia will be maintained with oxygen, nitrous oxide, sevoflurane (0.6-1 MAC) or propofol infusion (50-150 ug/kg/min).
The patients’s HR, NIBP, SpO2 will be recorded before the block, at the time of block and every 5 min up to 30 min after the block.
All the patients will be reversed and after extubation will be shifted to the post-operative anaesthesia care unit and monitored for 2 h, after which patient will be shifted to ward and will be monitored upto 24 h postoperatively.
The primary outcome measure of the study is to determine the quality of recovery, assessed using the Quality of Recovery (QoR-15) scale at 24 h post operatively.
The time from institution of block to the time for the first analgesic request in the post-opeartive period will be recorded.
the pain score on a VAS at rest and on arm movement will be monitored and the patient satisfaction and future willingness to undergo repeat peripheral nerve block will also be recorded at regular intervals for a period of 24 h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •American Society of Anesthesiologists (ASA) class I-II Age more than 18 years at the date of inclusion Females posted for breast surgery Who have received thorough information and have signed the informed written consent form.
排除标准
- •Patient refusal ASA III- IV including patient with severe respiratory,cardiovascular, liver and metabolic or pre-existing neurological deficit Skin infection at puncture site Allergy to study drugs Recent history of use of analgesic/steroid drugs Pregnant patient History of psychiatric illness and substance abuse.
- •Morbid obesity BMI >40 kg/m2 Coagulation abnormalities (INR>1.5,thrombocytopenia).
结局指标
主要结局
To evaluate the efficacy of dexmedetomidine
时间窗: At 24 hrs.
versus dexamethasone as an adjuvant to
时间窗: At 24 hrs.
ropivacaine on pain relief after costotransverse
时间窗: At 24 hrs.
block by determining the quality of recovery assessed using Quality of Recovery(QoR-15) scale at 24 hour post operatively.
时间窗: At 24 hrs.
次要结局
- To determine the time for first requirement of analgsia.(Total cumulative dose of rescue analgesic)