Clinical trial NCT04178200: Evaluation of Duration of Anesthesia and Patient Satisfaction After Retrobulbar Block Applied in Cataract Surgery
Official title: Evaluation of Duration of Anesthesia and Patient Satisfaction After Retrobulbar Block Applied in Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract Surgery
Patient Satisfaction
Akinesia
Anesthesia, Local
Anesthesia; Adverse Effect
Anesthesia Recovery Period
Keywords: Cataract
Retrobulbar Block
Ocular and eyelid
Akinesia
Anesthesia Recovery Period
Patient Satisfaction
Pain Score
Lead sponsor: Develi Devlet Hastanesi
Sponsor class: OTHER_GOV
First posted: 2019-11-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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,

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. To accept retrobulbar anesthesia before cataract surgery
2. To be over 18 and under 90
3. Being ASA I-II-III

Exclusion Criteria:

1. Not to accept local anesthesia
2. To be under 18 years
3. Having problems in communication
4. To have lid or eye anomaly
5. Being Parkinson's
6. Being myopia with axial length ≥ 26 mm
7. Hypersensitivity to local anesthetics or other drugs
8. Having bleeding or other drug related clotting problems

Primary outcomes:
measure: Patient Pain Score
timeFrame: Immediately after the surgery
measure: The scores of ocular and eyelid movements
timeFrame: at 1 minutes after the block
measure: The scores of ocular and eyelid movements
timeFrame: at 3 minutes after the block
measure: The scores of ocular and eyelid movements
timeFrame: at 5 minutes after the block
measure: The scores of ocular and eyelid movements
timeFrame: at 10 minutes after the block
measure: The postoperative scores of ocular and eyelid movements
timeFrame: at 30 minutes after the operation
measure: The postoperative scores of ocular and eyelid movements
timeFrame: at 60 minutes after the operation
measure: The postoperative scores of ocular and eyelid movements
timeFrame: at 90 minutes after the operation
measure: The postoperative scores of ocular and eyelid movements
timeFrame: at 120 minutes after the operation
measure: The postoperative scores of ocular and eyelid movements
timeFrame: at 150 minutes after the operation
measure: The postoperative scores of ocular and eyelid movements
timeFrame: at 180 minutes after the operation
measure: The postoperative scores of ocular and eyelid movements
timeFrame: at 210 minutes after the operation
measure: The scores of ocular and eyelid movements
timeFrame: at 240 minutes after the operation
Secondary outcomes:
measure: The need for analgesic and how many times it needs
timeFrame: One day after the surgery
measure: side effects questionnaire
timeFrame: One day after the surgery
Other outcomes:
Locations:
city: Develi
country: Turkey
facility: Develi Hatice Muammer Kocatürk Devlet Hastanesi
state: Kayseri
Study officials:
affiliation: Develi Devlet Hastanesi
name: Gamze ALBAYRAK, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barr J, Kirkpatrick N, Dick A, Leonard L, Hawksworth G, Noble DW. Effects of adrenaline and hyaluronidase on plasma concentrations of lignocaine and bupivacaine after peribulbar anaesthesia. Br J Anaesth. 1995 Dec;75(6):692-7. doi: 10.1093/bja/75.6.692.
citation: Sarvela PJ. Comparison of regional ophthalmic anesthesia produced by pH-adjusted 0.75% and 0.5% bupivacaine and 1% and 1.5% etidocaine, all with hyaluronidase. Anesth Analg. 1993 Jul;77(1):131-4. doi: 10.1213/00000539-199307000-00026.