Anesthetics, LocalPhase 4NCT03312959
Heavy Bupivacaine in Peribulbar Block
A Phase 4 study testing hyperbaric bupvacaine in Peribulbar block and isobaric bupvacaine in Peribulbar block in people with Anesthetics, Local, run by Cairo University at 1 site in Egypt.
Trial summary
Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Anesthetics, Local
- What is being tested?
- hyperbaric bupvacaine in Peribulbar block and isobaric bupvacaine in Peribulbar block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 31 Jan 2018
- Phase
- Phase 4
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiology (ASA) I or II.
- 30-80 years old
- Patients scheduled for elective unilateral posterior segment surgeries.
Who cannot join
- Patient's refusal.
- orbital deformity
- axial length( >28 mm )
- increased intraocular pressure, or if they were blind in the contralateral eye, international normalized ratio (INR) > 1.5
- allergy to local anesthetics, mentally retarded patients
Trial locations and contacts
1 site in 1 country.
Ahmed Badwy contact
About this study
Official title: Heavy Bupivacaine Versus Plain Bupivacaine in Peribulbar Block
Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Moreover, it is associated with less hemodynamic instability, less respiratory depression, better postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also associated with a reduction in stress response, maintained oxygen saturation and cardiovascular stability, in addition to the production of good akinesia and anesthesia alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe technique.
Read the detailed description
Peribulbar anesthesia is widely practiced now as a safe local block for cataract eye surgeries. However, the limited duration of these blocks was shown to be the main problem encountered intra-operatively. Therefore, additional top-up doses are usually needed to continue the operation. Many kinds of research tried to introduce solutions in order to prolong the duration of the local anesthetics used. Many researchers tried different volumes, doses and adjuvant to local anesthetics, and studied their effects There are many studies that evaluated the effect of baricity of local anesthetic on the potency of motor block and the duration of motor and sensory blockade.
However, no properly designed randomized, controlled studies have evaluated the feasibility and reliability of baricity local anesthetic agents used for the peribulbar block.
Aim of the work prospective, randomized study was conducted to evaluate the effects of the baricitized bupivacaine used for the peribulbar block in patients undergoing posterior segment surgeries.
- Conditions
- Anesthetics, Local
- Being tested
- hyperbaric bupvacaine in Peribulbar block, isobaric bupvacaine in Peribulbar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric bupvacaine in Peribulbar blockDrug
Also called trial group
hyperbaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery
isobaric bupvacaine in Peribulbar blockDrug
Also called control group
isobaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric bupvacaine group | Experimental | Peribulbar block will be performed using a total volume of 7 ml 6ml hyperbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline Receives: Drug: hyperbaric bupvacaine in Peribulbar block |
| isobaric bupvacaine group | Active comparator | Peribulbar block will be performed using a total volume of 7 ml 6ml isorbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline Receives: Drug: isobaric bupvacaine in Peribulbar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The onset and duration of lid and globe akinesia
scoring the ocular movements in each direction of gaze
Measured: 12 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion20 Jan 2018 (estimated)
- Study completion31 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetics, LocalStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312959
- Sponsor's protocol ID
- badway 2
- Status last verified
- Oct 2017
- First submitted
- 13 Oct 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- 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 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heavy Bupivacaine Versus Plain Bupivacaine in Peribulbar Block
- ClinicalTrials.gov ID
- NCT03312959
- Acronym / sponsor ID
- badway 2
- Conditions
- Anesthetics, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 20 Jan 2018 (estimated)
- Study completion
- 31 Jan 2018 (estimated)
- First posted
- 18 Oct 2017 (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.
Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Moreover, it is associated with less hemodynamic instability, less respiratory depression, better postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also associated with a reduction in stress response, maintained oxygen saturation and cardiovascular stability, in addition to the production of good akinesia and anesthesia alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe technique.
Detailed description
Peribulbar anesthesia is widely practiced now as a safe local block for cataract eye surgeries. However, the limited duration of these blocks was shown to be the main problem encountered intra-operatively. Therefore, additional top-up doses are usually needed to continue the operation. Many kinds of research tried to introduce solutions in order to prolong the duration of the local anesthetics used. Many researchers tried different volumes, doses and adjuvant to local anesthetics, and studied their effects There are many studies that evaluated the effect of baricity of local anesthetic on the potency of motor block and the duration of motor and sensory blockade.
However, no properly designed randomized, controlled studies have evaluated the feasibility and reliability of baricity local anesthetic agents used for the peribulbar block.
Aim of the work prospective, randomized study was conducted to evaluate the effects of the baricitized bupivacaine used for the peribulbar block in patients undergoing posterior segment surgeries.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric bupvacaine group | Experimental | Drug: hyperbaric bupvacaine in Peribulbar blockPeribulbar block will be performed using a total volume of 7 ml 6ml hyperbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline |
| isobaric bupvacaine group | Active comparator | Drug: isobaric bupvacaine in Peribulbar blockPeribulbar block will be performed using a total volume of 7 ml 6ml isorbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with American Society of Anesthesiology (ASA) I or II.
- 30-80 years old
- Patients scheduled for elective unilateral posterior segment surgeries.
Key exclusion criteria (5 listed)
- Patient's refusal.
- orbital deformity
- axial length( >28 mm )
- increased intraocular pressure, or if they were blind in the contralateral eye, international normalized ratio (INR) > 1.5
- allergy to local anesthetics, mentally retarded patients
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 |
|---|---|---|
| hyperbaric bupvacaine in Peribulbar blockAlso: trial grouphyperbaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery | Drug | hyperbaric bupvacaine group |
| isobaric bupvacaine in Peribulbar blockAlso: control groupisobaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery | Drug | isobaric bupvacaine group |
Primary outcome
The onset and duration of lid and globe akinesia
Time frame: 12 hours postoperative
scoring the ocular movements in each direction of gaze
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- 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.
Ahmed Badwy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hyperbaric bupvacaine in Peribulbar block and isobaric bupvacaine in Peribulbar block in people with Anesthetics, Local, run by Cairo University at 1 site 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 3 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 18 Oct 2017. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Hassan Ali (1001733687, hassan364@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The onset and duration of lid and globe akinesia (time frame: 12 hours postoperative). 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 Oct 2017.