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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178200
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Gamze ALBAYRAK, Develi Devlet Hastanesi

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,

Condition or disease Intervention/treatment
Cataract Surgery Patient Satisfaction Akinesia Anesthesia, Local Anesthesia; Adverse Effect Anesthesia Recovery Period Drug: Lidocaine 2% Injectable Solution 0.75 ml Drug: Bupivacaine Hcl 0.5% Inj 0.75 ml Drug: Lidocaine 2% Injectable Solution 1.5 ml Drug: Bupivacaine Hcl 0.5% Inj 1.5 ml

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Duration of Anesthesia and Patient Satisfaction After Retrobulbar Block Applied in Cataract Surgery
Estimated Study Start Date : December 16, 2019
Estimated Primary Completion Date : April 24, 2020
Estimated Study Completion Date : April 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
1.5 ml Dose
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
0.75 ml of Lidocaine will be added to the anesthetic solution.
Other Name: Lidocaine

Drug: Bupivacaine Hcl 0.5% Inj 0.75 ml
0.75 ml of Bupivacaine will be added to the anesthetic solution.
Other Name: Bupivacaine

3 ml Dose
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
1.5 ml of Lidocaine will be added to the anesthetic solution.
Other Name: Lidocaine

Drug: Bupivacaine Hcl 0.5% Inj 1.5 ml
1.5 ml of Bupivacaine will be added to the anesthetic solution.
Other Name: Bupivacaine




Primary Outcome Measures :
  1. Patient Pain Score [ Time Frame: Immediately after the surgery ]
    patient pain assessed by with pain score of 3 points-scale (0 No pain,1 Not comfortable, 2 Have pain )

  2. The scores of ocular and eyelid movements [ Time Frame: at 1 minutes after the block ]
    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.

  3. The scores of ocular and eyelid movements [ Time Frame: at 3 minutes after the block ]
    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.

  4. The scores of ocular and eyelid movements [ Time Frame: at 5 minutes after the block ]
    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.

  5. The scores of ocular and eyelid movements [ Time Frame: at 10 minutes after the block ]
    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.

  6. The postoperative scores of ocular and eyelid movements [ Time Frame: at 30 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.

  7. The postoperative scores of ocular and eyelid movements [ Time Frame: at 60 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.

  8. The postoperative scores of ocular and eyelid movements [ Time Frame: at 90 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.

  9. The postoperative scores of ocular and eyelid movements [ Time Frame: at 120 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.

  10. The postoperative scores of ocular and eyelid movements [ Time Frame: at 150 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.

  11. The postoperative scores of ocular and eyelid movements [ Time Frame: at 180 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.

  12. The postoperative scores of ocular and eyelid movements [ Time Frame: 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.

  13. The scores of ocular and eyelid movements [ Time Frame: 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.


Secondary Outcome Measures :
  1. The need for analgesic and how many times it needs [ Time Frame: One day after the surgery ]
    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.

  2. side effects questionnaire [ Time Frame: One day after the surgery ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178200


Contacts
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Contact: Hastane Başhekimliği +903526216020 kayseridhs2@saglik.gov.tr

Locations
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Turkey
Develi Hatice Muammer Kocatürk Devlet Hastanesi
Develi, Kayseri, Turkey, 38400
Sponsors and Collaborators
Develi Devlet Hastanesi
Investigators
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Principal Investigator: Gamze ALBAYRAK, MD Develi Devlet Hastanesi
Publications:
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Responsible Party: Gamze ALBAYRAK, Clinical Specialist Doctor, Develi Devlet Hastanesi
ClinicalTrials.gov Identifier: NCT04178200    
Other Study ID Numbers: 2019/776
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gamze ALBAYRAK, Develi Devlet Hastanesi:
Cataract
Retrobulbar Block
Ocular and eyelid
Akinesia
Anesthesia Recovery Period
Patient Satisfaction
Pain Score
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Lidocaine
Bupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action