Efficacy of Dexmedetomidine as an Adjuvant in Obturator Nerve Block for Postoperative Pain in Patients Undergoing Transurethral Surgeries Under Spinal Anesthesia : A Randomized Controlled Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Severity of pain measured by visual analog scale (VAS) score. postoperative pain after transurethral surgeries
研究概览
简要总结
in our study, we will investigate the impact of adding dexmedetomidine to bupivacaine for the potency of the obturator nerve block and prevention of the postoperative pain associated with transurethral surgery in comparison of obturator nerve block with bupivacaine alone
详细描述
- After history taking and examination of the labs and airway of the patient , An intravenous catheter will be secured in the dorsum of the hand of non dominant hand and patients will be monitored for heart rate, noninvasive blood pressure, and oxygen saturation.
- All patients after aseptic preparation will receive subarachnoid block in lumber 3-4 or 4-5 space in sitting position.
- About 3 ml (15mg) of heavy 0.5% bupivacaine will be injected into subarachnoid space.
- After the completion of the block, patients will be laid in the supine position and subsequently waited for 5 min for fixation of drug and assessed for sensorimotor block.
- Further procedure will be performed as per the group allocation.
- ONB will be performed by classic technique 1.5cm lateral and 1.5cm caudal to the pubic tuberacle . after contact with the pubic ramus is made , the needle is redirected laterally to a point 2-3 cm deeper than the pubic ramus.(15)
- A waiting period 20 min will be allowed for the full effect of the block and then resection will be allowed to perform
- Hemodynamics (heart rate, mean arterial blood pressure) will be recorded intraoperatively and postoperative at 0, 2 and 6 hours .
- VAS score at 0,2 and 6 hours post-operatively will be assessed.
- Time to first call for analgesic requirements (duration of analgesia) will be measured.
- Total postoperative analgesic consumption in the first 24 hours post-operative will be measured.
- Incidence of complications such as nerve injury, hematoma formation, local anesthetic toxicity, intravascular injection, bleeding and bladder perforation will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be adults (above 18 years) scheduled to undergo transurethral surgery under regional anesthesia.
- •ASA1, ASA2
排除标准
- •American Society of Anesthesiologists (ASA) physical class 3,4, severe cardiac comorbidity (impaired contractility with ejection fraction less than 50%, heart block, significant arrhythmias, tight valvular lesions), allergy to any study's drugs
研究组 & 干预措施
group Dexmedetomidine
: Patients in this group will receive regional anesthesia and obturator nerve block bilaterally (10 ml 2% preservative-free lignocaine along with 5 ml 0.5% preservative-free bupivacaine) and dexmedetomidine 100 mcg/mL (2µg/kg).
干预措施: Dexmedetomidine (Drug)
group Dexmedetomidine
: Patients in this group will receive regional anesthesia and obturator nerve block bilaterally (10 ml 2% preservative-free lignocaine along with 5 ml 0.5% preservative-free bupivacaine) and dexmedetomidine 100 mcg/mL (2µg/kg).
干预措施: Bupivacaine Hydrochloride (Drug)
group Bupivacaine
:Patients in this group will receive regional anesthesia and bilateral obturator nerve block only (10 ml 2% preservative-free lignocaine along with 5 ml 0.5% preservative-free bupivacaine).
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Severity of pain measured by visual analog scale (VAS) score. postoperative pain after transurethral surgeries
时间窗: 24 hours postoperatively
the VAS score consists of 10cm line where 0 represents NO PAIN and 10 represents SEVEREST FORM OF PAIN
次要结局
- • Incidence of adductor jerk reflex(intraoperative)
- • Perioperative analgesic consumption, which will be calculated as the total amount of opioids administered in the postoperative periods.(24 hours postoperative)
- • Incidence of adverse effects as bleeding and bladder perforation.(24 hours postoperative)