Anesthesia, LocalPhase 3NCT03713762
Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl
A Phase 3 study testing peribulbar block 1 lidocaine/bupivacaine and peribulbar block 2 lidocaine/bupivacaine/fentanyl in people with Anesthesia, Local, run by Centro Medico Docente la Trinidad.
Trial summary
Ophthalmological procedures such as cataract extraction can be carried out with a peribulbar block (PBB). The advantages of this anesthetic technique include a lower incidence of coughing, unwanted movements and emesis during awakening, in addition to providing adequate postoperative analgesia. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- peribulbar block 1 lidocaine/bupivacaine and peribulbar block 2 lidocaine/bupivacaine/fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2009to 30 Nov 2009
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients scheduled for cataract surgery (Cataract Extracapsular Extraction)
- With indication of regional anesthesia with peribulbar block
- Physical status ASA I or II
- Patients between 45 and 90 years of age
Who cannot join
- Allergic to amide-type anesthetics and fentanyl citrate
- Patients with a history of woody thorax
- Patients with uncompensated systemic diseases
- Patients in whom it was necessary to change the anesthetic technique due to insufficient analgesia or those in which the administration of intravenous analgesics was required during the operative period.
About this study
Official title: Anesthesia With Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl
Ophthalmological procedures such as cataract extraction can be carried out with a peribulbar block (PBB). The advantages of this anesthetic technique include a lower incidence of coughing, unwanted movements and emesis during awakening, in addition to providing adequate postoperative analgesia. The researchers want to investigate whether the use of fentanyl citrate by peribulbar route, when administered with a local anesthetic, shortens the anesthetic latency, interfere with the degree of akinesia and if provides greater postoperative analgesia.
Read the detailed description
Article Type. Clinical trial study
- Conditions
- Anesthesia, Local
- Being tested
- peribulbar block 1 lidocaine/bupivacaine, peribulbar block 2 lidocaine/bupivacaine/fentanyl
- Keywords
- Peribulbar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peribulbar block 1 lidocaine/bupivacaineDrug
Also called lidocaine/bupivacaine
Peribulbar block: 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml.
peribulbar block 2 lidocaine/bupivacaine/fentanylDrug
Also called lidocaine/bupivacaine/fentanyl
Peribulbar block: 100 mg of lidocaine 5%, 15 mg of 0.5% bupivacaine and 50 mcg of fentanyl citrate for a total volume of the anesthetic mixture of 6 ml.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 LB | Experimental | Peribulbar block 1 was performed received 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml Receives: Drug: peribulbar block 1 lidocaine/bupivacaine |
| Group 2 LBF | Experimental | Peribulbar block 2 was performed received 100 mg of lidocaine 5%, 15 mg of 0.5% bupivacaine and 50 mcg of fentanyl citrate for a total volume of the anesthetic mixture of 6 ml. Receives: Drug: peribulbar block 2 lidocaine/bupivacaine/fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency period (lost of corneal reflex)
lost of corneal reflex
Measured: 10 minutes until the start of surgery
Secondary outcomes (3)
Ocular akinesia: movements of extraocular muscles
movements of extraocular muscles
Measured: 10 minutes until the start of surgery
Incidence of postoperative pain
Analogous visual scale
Measured: 2 Hours
postoperative complications
bleeding or bruise
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Oct 2009
- Primary completion30 Nov 2009
- Study completion30 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico Docente la Trinidad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leopoldo Wulff, Centro Medico Docente la Trinidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713762
- Sponsor's protocol ID
- PBBCM
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia With Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl
- ClinicalTrials.gov ID
- NCT03713762
- Acronym / sponsor ID
- PBBCM
- Conditions
- Anesthesia, Local
- Keywords
- Peribulbar block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centro Medico Docente la TrinidadUniversity, hospital or other
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 30 Nov 2009 (actual)
- Study completion
- 30 Nov 2009 (actual)
- First posted
- 22 Oct 2018 (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.
Ophthalmological procedures such as cataract extraction can be carried out with a peribulbar block (PBB). The advantages of this anesthetic technique include a lower incidence of coughing, unwanted movements and emesis during awakening, in addition to providing adequate postoperative analgesia. The researchers want to investigate whether the use of fentanyl citrate by peribulbar route, when administered with a local anesthetic, shortens the anesthetic latency, interfere with the degree of akinesia and if provides greater postoperative analgesia.
Detailed description
Article Type. Clinical trial study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 LB | Experimental | Drug: peribulbar block 1 lidocaine/bupivacainePeribulbar block 1 was performed received 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml |
| Group 2 LBF | Experimental | Drug: peribulbar block 2 lidocaine/bupivacaine/fentanylPeribulbar block 2 was performed received 100 mg of lidocaine 5%, 15 mg of 0.5% bupivacaine and 50 mcg of fentanyl citrate for a total volume of the anesthetic mixture of 6 ml. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients scheduled for cataract surgery (Cataract Extracapsular Extraction)
- With indication of regional anesthesia with peribulbar block
- Physical status ASA I or II
- Patients between 45 and 90 years of age
Key exclusion criteria (4 listed)
- Allergic to amide-type anesthetics and fentanyl citrate
- Patients with a history of woody thorax
- Patients with uncompensated systemic diseases
- Patients in whom it was necessary to change the anesthetic technique due to insufficient analgesia or those in which the administration of intravenous analgesics was required during the operative period.
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 |
|---|---|---|
| peribulbar block 1 lidocaine/bupivacaineAlso: lidocaine/bupivacainePeribulbar block: 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml. | Drug | Group 1 LB |
| peribulbar block 2 lidocaine/bupivacaine/fentanylAlso: lidocaine/bupivacaine/fentanylPeribulbar block: 100 mg of lidocaine 5%, 15 mg of 0.5% bupivacaine and 50 mcg of fentanyl citrate for a total volume of the anesthetic mixture of 6 ml. | Drug | Group 2 LBF |
Primary outcome
Latency period (lost of corneal reflex)
Time frame: 10 minutes until the start of surgery
lost of corneal reflex
3 secondary outcomes
Ocular akinesia: movements of extraocular muscles
Time frame: 10 minutes until the start of surgery
Incidence of postoperative pain
Time frame: 2 Hours
postoperative complications
Time frame: 2 hours
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 23 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing peribulbar block 1 lidocaine/bupivacaine and peribulbar block 2 lidocaine/bupivacaine/fentanyl in people with Anesthesia, Local, run by Centro Medico Docente la Trinidad.
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 4 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Latency period (lost of corneal reflex) (time frame: 10 minutes until the start of surgery). 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 23 Oct 2018.