Fentanyl Versus Ketorolac as an Adjuvant to Peribulbar Block for Anterior Segment Surgeries, A Prospective Double-blinded Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Duration of globe akinesia
研究概览
简要总结
This study aims to compare the efficacy of ketorolac and fentanyl as adjuvants to local anesthetics for anterior segment surgeries of the eye.
详细描述
Regional anesthesia for eye surgery includes peribulbar, retrobulbar, and sub-Tenon's blocks. Peribulbar block is commonly used due to a lesser incidence of serious complications such as globe perforation and retrobulbar hemorrhage.
Fentanyl is a synthetic opioid widely used as an adjuvant to local anesthetics to prolong its action and provide better postoperative analgesia. fentanyl fastens lid and globe akinesia and provides a better akinesia score.
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that reduces the release of inflammatory mediators such as prostaglandins, thereby reducing afferent sensitivities and finally reducing pain. It is devoid of narcotic analgesic adverse effects such as sedation, nausea, and respiratory depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Scheduled to undergo operations for anterior segment surgeries of the eye under local (peribulbar) anesthesia.
排除标准
- •Patient's refusal.
- •Known allergy or hypersensitivity to aspirin or nonsteroidal anti-inflammatory medications.
- •Patients with contraindications to local anesthetics, such as high axial length or patients with high preoperative intraocular pressure.
- •If cases develop severe pain intraoperatively from the start, necessitating rescue analgesia and sedation or requiring conversion to general anesthesia.
- •Infection at the site of injection.
- •Patients with coagulopathies or on anticoagulants.
- •Impaired renal function.
研究组 & 干预措施
Fentanyl group
Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, and hyaluronidase 60 IU and fentanyl 20 μg diluted in normal saline to a total volume of 8 ml.
干预措施: Fentanyl + Lidocaine + Bupivacaine + Hyaluronidase (Drug)
Ketorolac group
Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, hyaluronidase 60 IU, and ketorolac 15 mg diluted in normal saline to a total volume of 8 ml.
干预措施: Ketorolac + Lidocaine + Bupivacaine + Hyaluronidase (Drug)
Control group
Patients will receive a mixture of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, hyaluronidase 60 IU diluted in normal saline to a total volume of 8 ml.
干预措施: Lidocaine + Bupivacaine + Hyaluronidase (Drug)
结局指标
主要结局
Duration of globe akinesia
时间窗: 10 minutes after injection
Assessment of Globe akinesia will be assessed at 2, 5 and 10 minutes after injection with a 12-point scale. Each of the four rectus muscles and each lid score from 0 to 2; 0 = total akinesia, 1 = partial akinesia, 2 = no akinesia)
次要结局
- Time of first rescue analgesia(6 hours postoperatively)
- Heart rate(Intraoperatively)
- Blood pressure(Intraoperatively)
- Onset of globe akinesia(10 minutes after injection)
- Onset of corneal anesthesia(1 minute after injection)
- Degree of pain(6 hours postoperatively)
研究者
Aya Mohamed Abo Zied
Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.
Cairo University