Evaluation of effectiveness of dexmedetomidine used as an adjuvant with ropivacaine 0.5 percent for ultrasound-guided iliohypogastric,ilioinguinal and genitofemoral nerve block as a sole anaesthetic technique in patients undergoing inguinal hernia repair A randomised double blinded controlled study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To compare Duration of Analgesia in both the groups
研究概览
简要总结
Inguinal hernioplasty is one of the most commonly performed surgical procedures all over the world. Subarachnoid block is routinely used as an anaesthetic technique of choice without much difficulties and adverse outcomes. However, certain comorbid conditions like ischaemic heart disease, valvular heart disease, coagulopathies, cardiomyopathy etc. increase the risk associated with and limits use of neuraxial blockade as a plan of anaesthesia. Bony deformities like kyphosis and scoliosis make subarachnoid block technically difficult and there is also unpredictable spread of local anaesthetic along subarachnoid space. In such scenarios, general anaesthesia remains the sole technique of choice to undergo planned surgery. This makes the patient bear a wide range of shortcomings like delayed recovery, intensive care unit (ICU) admission, mechanical ventilation, prolonged hospital stay with economic burden along with increased risk of morbidity and mortality.
Inguinal hernia block has wide range of advantages over general anaesthesia in patients with a compromised cardiac status and other co-morbidities. It avoids endotracheal intubation, polypharmacy and subsequent delayed recovery. Further, it decreases the need of ventilator support, provides adequate post-operative analgesia with reduced opioid requirement. The period of hospitalisation is also decreased thus reducing the economic burden.
Ilioinguinal nerve block (IINB), iliohypogastric nerve block (IHNB) and genital branch of the genitofemoral (GF) nerve blocks completes the anaesthesia and may be used for inguinal hernia repair surgeries.Direct ultrasonographic visualisation of these nerves improves the quality of the block, increases success rate to 95 percent, and reduces the risk for complications.
With this background, the present study will be conducted to evaluate the effectiveness of dexmedetomidine used as an adjuvant with ropivacaine 0.5 percent for ultrasound-guided ilioinguinal, iliohypogastric and genital branch of genitofemoral nerve block as a sole anaesthetic technique in patients undergoing inguinal hernia repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients with American Society of Anaesthesiologist (ASA) Physical Status (PS) 1 to 3
- •Duration of surgery less than 2 hours.
排除标准
- •Patients who will not give consent.
- •Infection at the puncture site.
- •Patients with age lesser than 18 years and greater than 65 years
- •Patients with BMI greater than 35 kg per m2
- •Patients with history of allergy to local anaesthetic or dexmedetomidine
- •Patients with resting heart rate lesser than 50 per min.
- •Patients with history of unstable angina or myocardial infarction or complete heart block.
- •Patients with history of any psychiatric,neurological disease or seizure disorder.
- •Patients with history of bleeding disorders or deranged coagulation profile.
结局指标
主要结局
To compare Duration of Analgesia in both the groups
时间窗: Duration of analgesia is the time postoperatively when patient will demand for rescue analgesia or when patients VAS score is equal to or more than 4 in first 24 hrs.
次要结局
- To compare Onset of sensory block(Immediately after block in minutes.)
- To compare visual analog scale(Assessed postoperatively at 1 hr 2 hr 4 hr 6 hr 12 hr 18 hr 25 hr)
- To compare total rescue analgesic consumption(postoperatively in first 24 hours)
- To compare postoperatively patient satisfaction score(Assessed after completion of surgery)
- To compare surgeon satisfaction score(Assessed after completion of surgery)
- To compare duration of sensory block(Assessed postoperatively in first 24 hrs)