An observational study in Cataract Surgery, Patient Satisfaction and Akinesia, sponsored by Develi Devlet Hastanesi. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-11-26.
Sponsored by Develi Devlet Hastanesi · Observational
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,
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 80 is close to the median of 81 across 484 observational studies indexed under Cataract.
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80 people will be included in the study. All adult patients of ASA (American Society of Anesthesiologists) I-II-III who accept retrobulbar anesthesia before cataract surgery will be included in the study.
The study will not include a vulnerable population, such as people with disabilities, children, pregnant women, puerperants and nursing women, people in intensive care and unconscious, and those who cannot give consent in person or vulnerable subjects.
Exclusion Criteria:
For retrobulbar anesthesia, 1.5 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients.
Drug: Lidocaine 2% Injectable Solution 0.75 ml · Drug: Bupivacaine Hcl 0.5% Inj 0.75 ml
For retrobulbar anesthesia, 3 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients.
Drug: Lidocaine 2% Injectable Solution 1.5 ml · Drug: Bupivacaine Hcl 0.5% Inj 1.5 ml
0.75 ml of Lidocaine will be added to the anesthetic solution.
Also known as: Lidocaine
0.75 ml of Bupivacaine will be added to the anesthetic solution.
Also known as: Bupivacaine
1.5 ml of Lidocaine will be added to the anesthetic solution.
Also known as: Lidocaine
1.5 ml of Bupivacaine will be added to the anesthetic solution.
Also known as: Bupivacaine
Patient Pain Score
patient pain assessed by with pain score of 3 points-scale (0 No pain,1 Not comfortable, 2 Have pain )
Time frame: Immediately after the surgery
The scores of ocular and eyelid movements
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.
Time frame: at 1 minutes after the block
The scores of ocular and eyelid movements
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.
Time frame: at 3 minutes after the block
The scores of ocular and eyelid movements
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.
Time frame: at 5 minutes after the block
The scores of ocular and eyelid movements
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.
Time frame: at 10 minutes after the block
The postoperative scores of ocular and eyelid movements
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.
Time frame: at 30 minutes after the operation
The postoperative scores of ocular and eyelid movements
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.
Time frame: at 60 minutes after the operation
The postoperative scores of ocular and eyelid movements
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.
Time frame: at 90 minutes after the operation
The postoperative scores of ocular and eyelid movements
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.
Time frame: at 120 minutes after the operation
The postoperative scores of ocular and eyelid movements
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.
Time frame: at 150 minutes after the operation
The postoperative scores of ocular and eyelid movements
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.
Time frame: at 180 minutes after the operation
The postoperative scores of ocular and eyelid movements
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.
Time frame: at 210 minutes after the operation
The scores of ocular and eyelid movements
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.
Time frame: at 240 minutes after the operation
The need for analgesic and how many times it needs
The patients will be asked whether they need analgesia (yes or no), if they need analgesia, they will be asked what time and how many times they take analgesic agents.
Time frame: One day after the surgery
side effects questionnaire
Ophthalmic side effects (Globe perforation, Pain at the injection site, Pressure sensation behind the eye, Subconjunctival hemorrhage, Retrobulbar hemorrhage, hematoma, ecchymosis, diplopia, ptosis) and other side effects (Nausea and vomiting, arrhythmia, Convulsion, Allergy, Weakness)
Time frame: One day after the surgery
Plan to share: No
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