Acute Postoperative PainPhase 3NCT04668456
Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery
A Phase 3 study testing Dexmedetomidine, lidocaine 2% and bupivacine 0.5% in people with Acute Postoperative Pain, run by Menoufia University at 3 sites in Egypt.
Trial summary
The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Postoperative Pain
- What is being tested?
- Dexmedetomidine, lidocaine 2% and bupivacine 0.5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesEgypt
- Study dates
- 15 Aug 2020to 30 Mar 2021
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA grade I-III
- Aged 18-70 years
- Both sex
- Scheduled for elective phacoemulsification cataract surgery
Who cannot join
- Coagulation abnormalities
- Impaired mental status
- Refusal of the patient
- Uncontrolled glaucoma
- Recent surgical procedure on the same eye
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Ashraf magdy Eskandr
Shibīn al Kawm, Monufia Governorate, 1234
Osama A Elmorsy
Shibīn al Kawm, Monufia Governorate, 1234
Sadik A Sadik
Shibīn al Kawm, Monufia Governorate, 1234
About this study
Official title: The Effect of Subtenon and Intravenous Dexmedetomidine on Patients Undergoing Cataract Surgery: A Comparative Randomized Controlled Double Blind Study
The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.
Read the detailed description
Ophthalmological surgery can be performed under topical, regional or general anesthesia. Recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. Orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-Tenon's block.
The STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury.
Dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics.
Many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.
- Conditions
- Acute Postoperative Pain
- Being tested
- Dexmedetomidine, lidocaine 2%, bupivacine 0.5%, Normal saline
- Keywords
- subtenon, dexmedetomidine, cataract surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
the drug administered either subtenon ot iv
lidocaine 2%Drug
subtenon injection
bupivacine 0.5%Drug
subtenon injection
Normal salineDrug
either subtenon or iv
| Study group | Role | What they receive |
|---|---|---|
| Group C (control group) | Placebo comparator | Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Receives: Drug: lidocaine 2%; Drug: bupivacine 0.5%; Drug: Normal saline |
| Group SD (subtenon dexmedetomiine) | Active comparator | Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Receives: Drug: Dexmedetomidine; Drug: lidocaine 2%; Drug: bupivacine 0.5%; Drug: Normal saline |
| Group ID (iv dexmedetomidine) | Active comparator | Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block. Receives: Drug: Dexmedetomidine; Drug: lidocaine 2%; Drug: bupivacine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of sensory block
time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia
Measured: 24 hours
Secondary outcomes (1)
duration of motor block
time from injection of local anesthetic to complete recovery of motor function in all ocular muscles.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start15 Aug 2020
- Primary completion14 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 75 Patients were assigned into three equal groups, all patients received 2.5 ml of local anesthetic mixture through subtenon block and IV infusion of drugs as follows: Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ashraf magdy eskandr, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668456
- Sponsor's protocol ID
- 8/8/2020 ANET4
- Status last verified
- Feb 2021
- First submitted
- 2 Dec 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subtenon and Intravenous Dexmedetomidine on Patients Undergoing Cataract Surgery: A Comparative Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT04668456
- Acronym / sponsor ID
- 8/8/2020 ANET4
- Conditions
- Acute Postoperative Pain
- Keywords
- subtenon, dexmedetomidine, cataract surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 14 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 16 Dec 2020 (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.
The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.
Detailed description
Ophthalmological surgery can be performed under topical, regional or general anesthesia. Recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. Orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-Tenon's block.
The STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury.
Dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics.
Many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- 75 Patients were assigned into three equal groups, all patients received 2.5 ml of local anesthetic mixture through subtenon block and IV infusion of drugs as follows: Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.
| Arm | Type | Receives |
|---|---|---|
| Group C (control group) | Placebo comparator | Drug: lidocaine 2%, Drug: bupivacine 0.5%, Drug: Normal salineGroup C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. |
| Group SD (subtenon dexmedetomiine) | Active comparator | Drug: Dexmedetomidine, Drug: lidocaine 2%, Drug: bupivacine 0.5%, Drug: Normal salineGroup SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. |
| Group ID (iv dexmedetomidine) | Active comparator | Drug: Dexmedetomidine, Drug: lidocaine 2%, Drug: bupivacine 0.5%Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA grade I-III
- Aged 18-70 years
- Both sex
- Scheduled for elective phacoemulsification cataract surgery
Key exclusion criteria (5 listed)
- Coagulation abnormalities
- Impaired mental status
- Refusal of the patient
- Uncontrolled glaucoma
- Recent surgical procedure on the same eye
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 |
|---|---|---|
| Dexmedetomidinethe drug administered either subtenon ot iv | Drug | Group ID (iv dexmedetomidine), Group SD (subtenon dexmedetomiine) |
| lidocaine 2%subtenon injection | Drug | Group C (control group), Group ID (iv dexmedetomidine), Group SD (subtenon dexmedetomiine) |
| bupivacine 0.5%subtenon injection | Drug | Group C (control group), Group ID (iv dexmedetomidine), Group SD (subtenon dexmedetomiine) |
| Normal salineeither subtenon or iv | Drug | Group C (control group), Group SD (subtenon dexmedetomiine) |
Primary outcome
duration of sensory block
Time frame: 24 hours
time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia
1 secondary outcome
duration of motor block
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine, lidocaine 2% and bupivacine 0.5% in people with Acute Postoperative Pain, run by Menoufia University at 3 sites in Egypt.
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 4 inclusion and 5 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
duration of sensory block (time frame: 24 hours). 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 25 Feb 2021.