CataractNCT04166578
Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery in Patients
An observational study of Cataract and Analgesia, run by Medical University of Lublin at 1 site in Poland.
Trial summary
Purpose: The aim of the study was to compare the analgetic effect of two solutions of intracameral anesthesia in patients undergoing cataract surgery and assess the factors influencing the patients' postoperative activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Analgesia, Ophthalmological Disorder
- What is being tested?
- lignocaine, Phacoemulsyfication and Intraocular lens implantation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2017to 31 Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 70 patients was initially scheduled to participate in this study. However, 8 patients did not attend the postoperative visits and were excluded. As a result, only 62 patients were included in the analysis. The mean age (±SD) of patients was 73.95 (±7.82) years. Female to male ratio was 55/45 in Mydrane group and 53/47 in the control group.
Who may be able to join
- age above 18 years
- best corrected visual acuity (BCVA) of 0.2 logMAR or worse
- and agreement for taking part in the study
Who cannot join
- depressive disorder or expected compliance problems (known psychiatric disease)
- epilepsy
- ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week before admission
- daily analgesic treatment
- intake of additional rescue medications due to the pain after surgery
- omitting postoperative visit
- no consent to complete the survey
- The patients who later needed additional medications for pain relief
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery: a Pilot Study
Purpose: The aim of the study was to compare the analgetic effect of two solutions of intracameral anesthesia in patients undergoing cataract surgery and assess the factors influencing the patients' postoperative activities.
Methods: In this prospective, single-blind, randomized study, a group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic. The analgetic effect of these two anesthetic methods was evaluated using psychological tools - Visual Analog Scale for Pain (VAS Pain) and Brief Pain Inventory-short form (BPI) on the next day after the surgery.
- Conditions
- Cataract, Analgesia, Ophthalmological Disorder
- Being tested
- lignocaine, Phacoemulsyfication, Intraocular lens implantation, Visual Analog Scale for Pain, Brief Pain Inventory-short form
- Medical subject headings
- Cataract, Agnosia, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lignocaineDrug
The group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic
PhacoemulsyficationProcedure or surgery
Phacoemulsification is a technic of cataract surgery in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye.
Intraocular lens implantationProcedure or surgery
An intraocular lens implant is a synthetic, artificial lens placed inside the eye that replaces the focusing power of a natural lens that is surgically removed, usually as part of cataract surgery.
Visual Analog Scale for PainBehavioural
Also called VAS for pain
VAS for Pain is a new tool developed to assess the pain in quantitative terms.
Brief Pain Inventory-short formBehavioural
Also called BPI short form
BPI short form is a tool developed to assess the pain in quantitative terms. The BPI allows patients to rate the severity of the pain and the grade to which their pain interferes with common dimensions of feeling and function.
Best corrected visual acuity measurmentDiagnostic test
Also called BCVA
Measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if your uncorrected eyesight is 20/200, but you can see 20/20 with glasses, your BCVA is 20/20.
Slit-lamp biomicroscopyDiagnostic test
Slit-lamp biomicroscopy allows study of ocular structures and their relationships.
| Study group | Role | What they receive |
|---|---|---|
| Mydrane group | Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification. Receives: Drug: lignocaine; Procedure: Phacoemulsyfication; Procedure: Intraocular lens implantation; Behavioral: Visual Analog Scale for Pain; Behavioral: Brief Pain Inventory-short form; Diagnostic Test: Best corrected visual acuity measurment; Diagnostic Test: Slit-lamp biomicroscopy | |
| Reference group | Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification. Receives: Drug: lignocaine; Procedure: Phacoemulsyfication; Procedure: Intraocular lens implantation; Behavioral: Visual Analog Scale for Pain; Behavioral: Brief Pain Inventory-short form; Diagnostic Test: Best corrected visual acuity measurment; Diagnostic Test: Slit-lamp biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean pain score measured with VAS Pain
The mean pain score measured with Visual Analog Scale for Pain (equivalent to 10 degrees).O points represented no pain and that the 10 points represented the most intense pain he or she felt throughout the surgical procedure.
Measured: preoperatively
The mean pain score measured with VAS Pain
The mean pain score measured with Visual Analog Scale for Pain (equivalent to 10 degrees).O points represented no pain and that the 10 points represented the most intense pain he or she felt throughout the surgical procedure.
Measured: postoperatively (the next day after surgery- 24 hours)
The range of pain was measured on the next day after surgery with BPI-short
The the mean severity score, the pain interference mean score was measured with Brief Pain Inventory-short form (BPI-short form). BPI is one of the most widely used measurement tools for assessing clinical pain. It contains two domains that measure pain intensity (severity) and the impact of pain on functioning (interference). In the current study, BPI was used to evaluate the severity of pain and the impact of pain on daily function in the previous 24 h. The responses were given using an eleven-point numeric rating scale (NRS) scored 0-10, where 0 = best outcome/does not interfere/no pain/complete pain relief and 10 = worst outcome/completely interferes/most pain/no pain relief.
Measured: the next day after surgery (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166578
- Sponsor's protocol ID
- 002
- Status last verified
- Nov 2019
- First submitted
- 13 Aug 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT04166578
- Acronym / sponsor ID
- 002
- Conditions
- Cataract, Analgesia, Ophthalmological Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 18 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.
Purpose: The aim of the study was to compare the analgetic effect of two solutions of intracameral anesthesia in patients undergoing cataract surgery and assess the factors influencing the patients' postoperative activities.
Methods: In this prospective, single-blind, randomized study, a group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic. The analgetic effect of these two anesthetic methods was evaluated using psychological tools - Visual Analog Scale for Pain (VAS Pain) and Brief Pain Inventory-short form (BPI) on the next day after the surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mydrane group | – | Drug: lignocaine, Procedure: Phacoemulsyfication, Procedure: Intraocular lens implantation, Behavioral: Visual Analog Scale for Pain, Behavioral: Brief Pain Inventory-short form, Diagnostic Test: Best corrected visual acuity measurment, Diagnostic Test: Slit-lamp biomicroscopyPatients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification. |
| Reference group | – | Drug: lignocaine, Procedure: Phacoemulsyfication, Procedure: Intraocular lens implantation, Behavioral: Visual Analog Scale for Pain, Behavioral: Brief Pain Inventory-short form, Diagnostic Test: Best corrected visual acuity measurment, Diagnostic Test: Slit-lamp biomicroscopyPatients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 70 patients was initially scheduled to participate in this study. However, 8 patients did not attend the postoperative visits and were excluded. As a result, only 62 patients were included in the analysis. The mean age (±SD) of patients was 73.95 (±7.82) years. Female to male ratio was 55/45 in Mydrane group and 53/47 in the control group.
Key inclusion criteria (3 listed)
- age above 18 years
- best corrected visual acuity (BCVA) of 0.2 logMAR or worse
- and agreement for taking part in the study
Key exclusion criteria (8 listed)
- depressive disorder or expected compliance problems (known psychiatric disease)
- epilepsy
- ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week before admission
- daily analgesic treatment
- intake of additional rescue medications due to the pain after surgery
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 |
|---|---|---|
| lignocaineThe group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic | Drug | Mydrane group, Reference group |
| PhacoemulsyficationPhacoemulsification is a technic of cataract surgery in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye. | Procedure or surgery | Mydrane group, Reference group |
| Intraocular lens implantationAn intraocular lens implant is a synthetic, artificial lens placed inside the eye that replaces the focusing power of a natural lens that is surgically removed, usually as part of cataract surgery. | Procedure or surgery | Mydrane group, Reference group |
| Visual Analog Scale for PainAlso: VAS for painVAS for Pain is a new tool developed to assess the pain in quantitative terms. | Behavioural | Mydrane group, Reference group |
| Brief Pain Inventory-short formAlso: BPI short formBPI short form is a tool developed to assess the pain in quantitative terms. The BPI allows patients to rate the severity of the pain and the grade to which their pain interferes with common dimensions of feeling and function. | Behavioural | Mydrane group, Reference group |
| Best corrected visual acuity measurmentAlso: BCVAMeasurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if your uncorrected eyesight is 20/200, but you can see 20/20 with glasses, your BCVA is 20/20. | Diagnostic test | Mydrane group, Reference group |
| Slit-lamp biomicroscopySlit-lamp biomicroscopy allows study of ocular structures and their relationships. | Diagnostic test | Mydrane group, Reference group |
Primary outcome
The mean pain score measured with VAS Pain
Time frame: preoperatively
The mean pain score measured with Visual Analog Scale for Pain (equivalent to 10 degrees).O points represented no pain and that the 10 points represented the most intense pain he or she felt throughout the surgical procedure.
The mean pain score measured with VAS Pain
Time frame: postoperatively (the next day after surgery- 24 hours)
The mean pain score measured with Visual Analog Scale for Pain (equivalent to 10 degrees).O points represented no pain and that the 10 points represented the most intense pain he or she felt throughout the surgical procedure.
The range of pain was measured on the next day after surgery with BPI-short
Time frame: the next day after surgery (24 hours)
The the mean severity score, the pain interference mean score was measured with Brief Pain Inventory-short form (BPI-short form). BPI is one of the most widely used measurement tools for assessing clinical pain. It contains two domains that measure pain intensity (severity) and the impact of pain on functioning (interference). In the current study, BPI was used to evaluate the severity of pain and the impact of pain on daily function in the previous 24 h. The responses were given using an eleven-point numeric rating scale (NRS) scored 0-10, where 0 = best outcome/does not interfere/no pain/complete pain relief and 10 = worst outcome/completely interferes/most pain/no pain relief.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Analgesia, run by Medical University of Lublin at 1 site in Poland.
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: finished, as of the sponsor's last update on 18 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean pain score measured with VAS Pain (time frame: preoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2019.