Vitreoretinal SurgeryNCT07519694
Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery
A study testing · Group M (Midazolam): and · Group C (Cisatracurium): in people with Vitreoretinal Surgery, run by Sohag University at 1 site in Egypt.
Trial summary
Peribulbar block, is the favored anesthetic technique for numerous ophthalmic procedures due to its lower rate of associated complications . Retinal surgeries have many problems to the anesthesiologists as these operations are often lengthy , involve a significant risk of postoperative pain ,and typically involve an… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitreoretinal Surgery
- What is being tested?
- · Group M (Midazolam): and · Group C (Cisatracurium):
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III patients -enrolled for elective vitreoretinal procedures under peribulbar block.
Who cannot join
- Patient refusal
- allergy to study drugs
- coagulopathy
- infection at the injection site
- significant axial myopia (axial length >26mm)
- neurological or neuromuscular disorders
- pregnancy
- inability to communicate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Suhag faculty of medicine
Sohag, Sohag Governorate, 0123
waleed Ahmed, 01006392210, waleed.salama@med.sohag.edu.eg
About this study
Official title: Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery (Prospective Comparative Randomized Controlled Trial
Peribulbar block, is the favored anesthetic technique for numerous ophthalmic procedures due to its lower rate of associated complications .
Retinal surgeries have many problems to the anesthesiologists as these operations are often lengthy , involve a significant risk of postoperative pain ,and typically involve an elderly patient population with multiple comorbidities .
Read more
Many anesthesiologists consider the peribulbar block as a safe technique; however, it has the disadvantage of a slow onset of orbital akinesia and to produce it a more substantial volume or repeated injections of local anesthetic solution is required due to limited diffusion of local anesthetics . This also increases the frequency of complications, such as globe perforation and peribulbar hemorrhage .
To prevent this and to increase tissue perfusion, hyaluronidase and other adjuvants such as clonidine, epinephrine and alkalinization of local anesthetics were used to improve peribulbar block.
Hyaluronidase may reduce tissue viscosity , which facilitate the complete diffusion of anesthetic solution along tissue planes .
in regional anesthesia is the addition of hyaluronidase is associated with benefits such as faster onest of action and impoved block quality ,however ,evidence regarding its efficacy in peribulbar techniques remains inconsistent.
To improve the quality and duration of the block, various adjuvants have been investigated. Two promising agents are Midazolam, a benzodiazepine with hypothesized peripheral GABA-ergic action, and Cisatracurium, a non-depolarizing neuromuscular blocking agent. Midazolam may enhance sensory block and provide amnesia, while cisatracurium directly induces chemical paralysis of the extraocular muscles. However, a direct comparative study of their efficacy and safety profiles in this context is lacking. This study aims to fill that gap .
90 eligible patients were randomly allocated into three groups using computer-generated random numbers placed in sealed, opaque envelopes.
- Group L (Control): lidocaine 2٪ (4 ml) + Normal Saline (1 ml).
- Group M (Midazolam): lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml).
- Group C (Cisatracurium): lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml).
The total volume of the injectate was standardized to 5 ml for all groups.
- Conditions
- Vitreoretinal Surgery
- Being tested
- · Group M (Midazolam):, · Group C (Cisatracurium):, Group L (Control)
- Keywords
- Ophthalmic anesthesia., Vitreoretinal surgery,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
· Group M (Midazolam):Drug
peribulber injection of idocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml).
· Group C (Cisatracurium):Drug
peribulber injection of lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml).
Group L (Control)Drug
peribulber injection of lidocaine 2٪ (4 ml) + Normal Saline (1 ml).
| Study group | Role | What they receive |
|---|---|---|
| · Group L (Control): lidocaine 2٪ (4 ml) + Normal Saline (1 ml). | Placebo comparator | · Group L (Control): peribulper lidocaine 2٪ (4 ml) + Normal Saline (1 ml). Receives: Drug: Group L (Control) |
| Group M (Midazolam): lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml). | Active comparator | Group M (Midazolam):peribulber injection of lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml). Receives: Drug: · Group M (Midazolam): |
| · Group C (Cisatracurium): lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline ( | Active comparator | · Group C (Cisatracurium): peribulber injection oflidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml). Receives: Drug: · Group C (Cisatracurium): |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Akinesia
onset of muscle paralysis (loss of muscle tone)
Measured: investigator assess muscle tone immediately after start of anesthesia and every 15 minute up to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Adel Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519694
- Sponsor's protocol ID
- soh-med-25-10----18PD
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery (Prospective Comparative Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07519694
- Acronym / sponsor ID
- soh-med-25-10----18PD
- Conditions
- Vitreoretinal Surgery
- Keywords
- Ophthalmic anesthesia., Vitreoretinal surgery,
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 9 Apr 2026 (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.
Peribulbar block, is the favored anesthetic technique for numerous ophthalmic procedures due to its lower rate of associated complications .
Retinal surgeries have many problems to the anesthesiologists as these operations are often lengthy , involve a significant risk of postoperative pain ,and typically involve an elderly patient population with multiple comorbidities .
Many anesthesiologists consider the peribulbar block as a safe technique; however, it has the disadvantage of a slow onset of orbital akinesia and to produce it a more substantial volume or repeated injections of local anesthetic solution is required due to limited diffusion of local anesthetics . This also increases the frequency of complications, such as globe perforation and peribulbar hemorrhage .
To prevent this and to increase tissue perfusion, hyaluronidase and other adjuvants such as clonidine, epinephrine and alkalinization of local anesthetics were used to improve peribulbar block.
Hyaluronidase may reduce tissue viscosity , which facilitate the complete diffusion of anesthetic solution along tissue planes .
in regional anesthesia is the addition of hyaluronidase is associated with benefits such as faster onest of action and impoved block quality ,however ,evidence regarding its efficacy in peribulbar techniques remains inconsistent.
To improve the quality and duration of the block, various adjuvants have been investigated. Two promising agents are Midazolam, a benzodiazepine with hypothesized peripheral GABA-ergic action, and Cisatracurium, a non-depolarizing neuromuscular blocking agent. Midazolam may enhance sensory block and provide amnesia, while cisatracurium directly induces chemical paralysis of the extraocular muscles. However, a direct comparative study of their efficacy and safety profiles in this context is lacking. This study aims to fill that gap .
90 eligible patients were randomly allocated into three groups using computer-generated random numbers placed in sealed, opaque envelopes.
- Group L (Control): lidocaine 2٪ (4 ml) + Normal Saline (1 ml).
- Group M (Midazolam): lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml).
- Group C (Cisatracurium): lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml).
The total volume of the injectate was standardized to 5 ml for all groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| · Group L (Control): lidocaine 2٪ (4 ml) + Normal Saline (1 ml). | Placebo comparator | Drug: Group L (Control)· Group L (Control): peribulper lidocaine 2٪ (4 ml) + Normal Saline (1 ml). |
| Group M (Midazolam): lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml). | Active comparator | Drug: · Group M (Midazolam):Group M (Midazolam):peribulber injection of lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml). |
| · Group C (Cisatracurium): lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline ( | Active comparator | Drug: · Group C (Cisatracurium):· Group C (Cisatracurium): peribulber injection oflidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I-III patients -enrolled for elective vitreoretinal procedures under peribulbar block.
Key exclusion criteria (8 listed)
- Patient refusal
- allergy to study drugs
- coagulopathy
- infection at the injection site
- significant axial myopia (axial length >26mm)
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 |
|---|---|---|
| · Group M (Midazolam):peribulber injection of idocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml). | Drug | Group M (Midazolam): lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml). |
| · Group C (Cisatracurium):peribulber injection of lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml). | Drug | · Group C (Cisatracurium): lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline ( |
| Group L (Control)peribulber injection of lidocaine 2٪ (4 ml) + Normal Saline (1 ml). | Drug | · Group L (Control): lidocaine 2٪ (4 ml) + Normal Saline (1 ml). |
Primary outcome
Onset of Akinesia
Time frame: investigator assess muscle tone immediately after start of anesthesia and every 15 minute up to end of surgery
onset of muscle paralysis (loss of muscle tone)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing · Group M (Midazolam): and · Group C (Cisatracurium): in people with Vitreoretinal Surgery, run by Sohag 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 1 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: opening soon, as of the sponsor's last update on 9 Apr 2026. 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. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact waleed adel Ahmed, lecturer (+201006392210, waleed.salama@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of Akinesia (time frame: investigator assess muscle tone immediately after start of anesthesia and every 15 minute up to end 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 9 Apr 2026.