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临床试验/NCT04178200
NCT04178200Unknown不适用

Evaluation of Duration of Anesthesia and Patient Satisfaction After Retrobulbar Block Applied in Cataract Surgery

Develi Devlet Hastanesi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年12月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Patient Pain Score

研究概览

简要总结

It is aimed to determine patient satisfaction (pain assessment during and after the operation) and the initial and total anesthesia durations of eye lid and globe anesthesia after administration of local anesthetic solution only in standard applied volumes (1.5-3 ml). No agents will be added to the local anesthetic agents used in the conventional retrobulbar block in patients who will undergo cataract surgery,

详细描述

In this study, 80 patients with American Society of Anesthesiologists (ASA) I-II-III who accepted retrobulbar anesthesia before cataract surgery and who were over 18 years of age and under 90 years of age were included in the study. Not accepting local anesthesia, being under 18 years of age, having problems in communication, having eyelid or eye anomaly, having Parkinson's disease, myopia with axial length ≥ 26 mm, hypersensitivity to local anesthetics or other drugs, and bleeding or other drug-induced clotting problem were determined as exclusion criteria for the investigator's study.

Written informed consent will be obtained from patients eligible for the study according to the above criteria. While obtaining informed consent, it will also be verbally stated that this study does not include any risks other than the risks of standard cataract surgery and retrobulbar block.

Patients taken to the operating room before the operation will be monitored and baseline blood pressure, pulse and peripheral capillary oxygen saturation (SpO2) values will be recorded. 2lt / min oxygen will be administered to patients with a nasal cannula. The normal ocular and valve movements of the patient will be checked and recorded before the procedure. Patients will receive a 20 gauge intravenous (IV) cannula. Before the retrobulbar block is applied, topical anesthesia is provided with 0.5% proparacaine drops and field cleaning with povidone iodine will be performed. The patient will be instructed to look at the finger held by the assistant personnel to bring the eyeball to the neutral position and the local anesthetic mixture will be slowly injected into the retrobulbar area with a 25 gauge ophthalmic needle. For retrobulbar anesthesia, 1.5-3 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients. The maximum treatment duration is 1 day and single dose. Gently massage the eye to disperse the local anesthetic solution and reduce bleeding. After block 1, 3, 5 and 10 minutes ocular movements and valve movements will be evaluated. To do this, patients will be told to look up, down, right and left and be asked to squeeze and open their eyelids. Ocular movements will be scored for each direction separately if normal, 2 if slightly restricted, and 0 if there is no movement (total score 0-8) [1]. In the evaluation of eye lid movements, complete immobility will be scored as 0, partial movement as 1 and normal movement as 2 [2]. The patient's blood pressure, pulse and SpO2 values will be recorded at 5 min intervals throughout the operation. During the operation, the pain of the patients will be assessed by a 3-point scale (0: no pain; 1: uncomfortable; 3: pain). Postoperative ocular and eye lid akinesia scores of the patients will be recorded at 30-minute intervals. Ocular and eye lid akinesia times will be recorded. Any side effects that occur during and after the procedure will be recorded. One day later, patients' responses will be recorded by asking for the first time and the number of times they need analgesics.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To accept retrobulbar anesthesia before cataract surgery
  • To be over 18 and under 90
  • Being ASA I-II-III

排除标准

  • Not to accept local anesthesia
  • To be under 18 years
  • Having problems in communication
  • To have lid or eye anomaly
  • Being Parkinson's
  • Being myopia with axial length ≥ 26 mm
  • Hypersensitivity to local anesthetics or other drugs
  • Having bleeding or other drug related clotting problems

研究组 & 干预措施

1.5 ml Dose

For retrobulbar anesthesia, 1.5 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients.

干预措施: Lidocaine 2% Injectable Solution 0.75 ml (Drug)

1.5 ml Dose

For retrobulbar anesthesia, 1.5 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients.

干预措施: Bupivacaine Hcl 0.5% Inj 0.75 ml (Drug)

3 ml Dose

For retrobulbar anesthesia, 3 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients.

干预措施: Lidocaine 2% Injectable Solution 1.5 ml (Drug)

3 ml Dose

For retrobulbar anesthesia, 3 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients.

干预措施: Bupivacaine Hcl 0.5% Inj 1.5 ml (Drug)

结局指标

主要结局

Patient Pain Score

时间窗: Immediately after the surgery

patient pain assessed by with pain score of 3 points-scale (0 No pain,1 Not comfortable, 2 Have pain )

The postoperative scores of ocular and eyelid movements

时间窗: at 210 minutes after the operation

Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.

The scores of ocular and eyelid movements

时间窗: at 240 minutes after the operation

Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.

次要结局

  • The need for analgesic and how many times it needs(One day after the surgery)
  • side effects questionnaire(One day after the surgery)

研究者

发起方
Develi Devlet Hastanesi
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gamze ALBAYRAK

Clinical Specialist Doctor

Develi Devlet Hastanesi

研究点 (1)

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