Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Sensory block
研究概览
简要总结
Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal, epidural, caudal anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration of postoperative analgesia.The aim of this study is evaluation of the effect of nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing cataract surgery
详细描述
44 patients (22 in each group) scheduled for elective cataract surgery using peribulbar block. Patients of Group N received local anesthetics received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group C received 6 ml of 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml).
Addition of nalbuphine to bupivacaine in peribulbar block is associated with reduced the time of onset of globe akinesia, increased the duration of globe akinesia and analgesia with better postoperative pain relief
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
The enrolled patients were randomized according to computer-generated random number into two equal groups of twenty two patients each and concealed using sequentially numbered sealed opaque envelopes.
Patients of Group N received local anesthetics received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU) , and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group C received 6 ml of 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged 40-60 years.
- •both sex.
- •ASA physical status Ι&II.
- •Patient with axial globe length below 26
排除标准
- •Refusal of the patient to participate in the study.
- •Coagulation abnormalities(INR>1.4).
- •More than ASA II.
- •High myopia with axial length more than 26 mm.
- •Mentally retarded patients and failure of proper communication as in deafness .
- •Morbidly obese patients(BMI>35)
- •Patients with glaucoma (increased IOP>20mmgh)
- •Patients with history of hypersensitivity to study drugs
研究组 & 干预措施
Group N
group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU) and 4mg of nalbuphine in 1 ml normal saline.
Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe. If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study
干预措施: Nalbuphine (Drug)
Group N
group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU) and 4mg of nalbuphine in 1 ml normal saline.
Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe. If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study
干预措施: lidocaine, bupivacaine , hyaluronidase (Drug)
Group C
Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline
干预措施: lidocaine, bupivacaine, hyaluronidase , saline (Drug)
结局指标
主要结局
Sensory block
时间窗: 12 hours Postoperative
Duration of the sensory block
次要结局
- Sensory block onset(12 hours Postoperative)
- Adverse effects of the used drugs(24 hours postoperatively)
- Satisfaction assessed at the end of surgical procedure by using a three-point scale(6 hours Postoperative)
- Motor block(12 hours Postoperative)
- Mean Arterial blood pressure(24 hours postoperatively)
研究者
Ahmed Abdalla
Assistant Professor of Anesthesia&I.C.U and Pain Clinic
Cairo University