Cataract SurgeryNCT04178200
Evaluation of Duration of Anesthesia and Patient Satisfaction After Retrobulbar Block Applied in Cataract Surgery
An observational study of Cataract Surgery and Patient Satisfaction, run by Develi Devlet Hastanesi at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cataract Surgery, Patient Satisfaction, Akinesia
- What is being tested?
- Lidocaine 2% Injectable Solution 0.75 ml, Bupivacaine Hcl 0.5% Inj 0.75 ml and Lidocaine 2% Injectable Solution 1.5 ml
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2019to 24 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- To accept retrobulbar anesthesia before cataract surgery
- To be over 18 and under 90
- Being ASA I-II-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Develi Hatice Muammer Kocatürk Devlet Hastanesi
Develi, Kayseri, 38400
About this study
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,
Read the 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.
- Conditions
- Cataract Surgery, Patient Satisfaction, Akinesia, Anesthesia, Local, Anesthesia; Adverse Effect, Anesthesia Recovery Period
- Being tested
- Lidocaine 2% Injectable Solution 0.75 ml, Bupivacaine Hcl 0.5% Inj 0.75 ml, Lidocaine 2% Injectable Solution 1.5 ml, Bupivacaine Hcl 0.5% Inj 1.5 ml
- Keywords
- Cataract, Retrobulbar Block, Ocular and eyelid, Akinesia, Anesthesia Recovery Period, Patient Satisfaction, Pain Score
- Medical subject headings
- Patient Satisfaction, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% Injectable Solution 0.75 mlDrug
Also called Lidocaine
0.75 ml of Lidocaine will be added to the anesthetic solution.
Bupivacaine Hcl 0.5% Inj 0.75 mlDrug
Also called Bupivacaine
0.75 ml of Bupivacaine will be added to the anesthetic solution.
Lidocaine 2% Injectable Solution 1.5 mlDrug
Also called Lidocaine
1.5 ml of Lidocaine will be added to the anesthetic solution.
Bupivacaine Hcl 0.5% Inj 1.5 mlDrug
Also called Bupivacaine
1.5 ml of Bupivacaine will be added to the anesthetic solution.
| Study group | Role | What they receive |
|---|---|---|
| 1.5 ml Dose | For retrobulbar anesthesia, 1.5 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients. Receives: Drug: Lidocaine 2% Injectable Solution 0.75 ml; Drug: Bupivacaine Hcl 0.5% Inj 0.75 ml | |
| 3 ml Dose | For retrobulbar anesthesia, 3 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients. Receives: Drug: Lidocaine 2% Injectable Solution 1.5 ml; Drug: Bupivacaine Hcl 0.5% Inj 1.5 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Score
patient pain assessed by with pain score of 3 points-scale (0 No pain,1 Not comfortable, 2 Have pain )
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 240 minutes after the operation
Secondary outcomes (2)
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.
Measured: 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)
Measured: One day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start16 Dec 2019 (estimated)
- Primary completion24 Apr 2020 (estimated)
- Study completion24 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Develi Devlet Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gamze ALBAYRAK, Develi Devlet Hastanesi
- Investigators
- Gamze ALBAYRAK, MD, Principal investigator, Develi Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178200
- Sponsor's protocol ID
- 2019/776
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8672315Sarvela 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.
PubMed 8317720
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Duration of Anesthesia and Patient Satisfaction After Retrobulbar Block Applied in Cataract Surgery
- ClinicalTrials.gov ID
- NCT04178200
- Acronym / sponsor ID
- 2019/776
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Develi Devlet HastanesiOther government
- Study start
- 16 Dec 2019 (estimated)
- Primary completion
- 24 Apr 2020 (estimated)
- Study completion
- 24 Apr 2020 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.5 ml Dose | – | Drug: Lidocaine 2% Injectable Solution 0.75 ml, Drug: Bupivacaine Hcl 0.5% Inj 0.75 mlFor retrobulbar anesthesia, 1.5 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients. |
| 3 ml Dose | – | Drug: Lidocaine 2% Injectable Solution 1.5 ml, Drug: Bupivacaine Hcl 0.5% Inj 1.5 mlFor retrobulbar anesthesia, 3 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- To accept retrobulbar anesthesia before cataract surgery
- To be over 18 and under 90
- Being ASA I-II-III
Key exclusion criteria (8 listed)
- Not to accept local anesthesia
- To be under 18 years
- Having problems in communication
- To have lid or eye anomaly
- Being Parkinson's
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 2% Injectable Solution 0.75 mlAlso: Lidocaine0.75 ml of Lidocaine will be added to the anesthetic solution. | Drug | 1.5 ml Dose |
| Bupivacaine Hcl 0.5% Inj 0.75 mlAlso: Bupivacaine0.75 ml of Bupivacaine will be added to the anesthetic solution. | Drug | 1.5 ml Dose |
| Lidocaine 2% Injectable Solution 1.5 mlAlso: Lidocaine1.5 ml of Lidocaine will be added to the anesthetic solution. | Drug | 3 ml Dose |
| Bupivacaine Hcl 0.5% Inj 1.5 mlAlso: Bupivacaine1.5 ml of Bupivacaine will be added to the anesthetic solution. | Drug | 3 ml Dose |
Primary outcome
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 )
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
The need for analgesic and how many times it needs
Time frame: One day after the surgery
side effects questionnaire
Time frame: One day after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Background: PubMed 8672315Barr 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.
- Background: PubMed 8317720Sarvela 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze ALBAYRAK, MD principal investigator
Develi Devlet Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Surgery and Patient Satisfaction, run by Develi Devlet Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hastane Başhekimliği (+903526216020, kayseridhs2@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Pain Score (time frame: Immediately after the surgery). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178200, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.