A Randomized comparative study to Compare different doses of Dexmedetomidine combined with Ropivacaine to assess post-operative analgesia using ultrasound-guided Supraclavicular Brachial Plexus Block in Upper Limb Surgeries- in Department of Anaesthesia at SMS Hospital, Jaipur
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1.Mean Duration of analgesia (minutes)
研究概览
简要总结
Supraclavicular brachial plexus block has been the choice of anaesthesia for upper limb surgeries .The addition of adjuvant to local anesthetic not only augments the anaesthetic action of the drug but also reduces the dose required thus improving the safety margin. Prolonging postoperative analgesia using various adjuvants has become a trend in regional anesthesia practice .which provides effective pain relief during intra operative and early postoperative period along with avoiding the risks of general anaesthesia.
In this study, we plan to compare different doses of Dexmedetomidine combined with Ropivacaine to determine their effectiveness in prolonging sensory and motor block and duration of analgesia in patients undergoing upper limb surgeries .For this a total of seventy patients (n=70) undergoing elective ultrasound-guided supraclavicular brachial plexus block who satisfy the inclusion criteria will be randomly divided into two groups of 35 each (A and B). Group A patients will be receiving Perineural: 20ml 0.5% ropivacaine + 25mcg Dexmedetomidine diluted in 1ml NS (total-21ml)for ultrasound-guided supraclavicular brachial plexus blockand group B will be receiving Perineural: 20ml 0.5% ropivacaine + 50mcg Dexmedetomidine diluted in 1ml NS (total-21ml) for ultrasound-guided supraclavicular brachial plexus block.
When patients arrive in the operating room(OR), intravenous cannula (IV cannula) will be inserted and hemodynamic variables will be measured. After this ultrasound-guided supraclavicular brachial plexus block will be administered using different doses of dexmedetomidine as an adjuvant to Ropivacaine in groupA and groupB. Surgery will be allowed to proceed after the adequate effect is achieved. Quantitative values of time of onset of sensory loss, time of onset of motor loss, time taken for motor regression, duration of post operative analgesia, hemodynamic parameters, sedation score and side effects if any will be recorded
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
- •1.Patient posted for upper limb surgeries
- •Either sex
- •Age-between 18 and 60 years
- •American Society ofAnesthesiologists Physical Status (ASA‑PS) Classes I and II 5.Bodyweight: 40-70 kg 6.Patients who will give informed written consent.
排除标准
- •1.Patient should not be a part of other study.
- •2.Nonco-operative patient.
- •3.Patients having severe systemic illness and bleeding disorders, 4.Pregnant women 5.Patients allergic to study drugs 6.Patients havingpre-existing sensory and motor deficit 7.Local site infection or deformity if any at the injection site.
结局指标
主要结局
1.Mean Duration of analgesia (minutes)
时间窗: Postoperative 4hr | Postoperative 8hr | Postoperative 12hr | Postoperative 16hr | Postoperative 20hr | Postoperative 24hr
2.Mean of NRS score
时间窗: Postoperative 4hr | Postoperative 8hr | Postoperative 12hr | Postoperative 16hr | Postoperative 20hr | Postoperative 24hr
次要结局
- 1.Mean time of onset of sensory block (minutes)(2.Mean time of onset of motor block (minutes))
研究者
Dr Poonam Kalra
SMS medical college jaipur