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Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery

Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery (Prospective Comparative Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07519694
Enrollment
90
Registered
2026-04-09
Start date
2026-05-01
Completion date
2026-06-15
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitreoretinal Surgery

Keywords

Ophthalmic anesthesia., Vitreoretinal surgery,

Brief 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 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.

Interventions

DRUG· Group M (Midazolam):

peribulber injection of idocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml).

DRUG· Group C (Cisatracurium):

peribulber injection of lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml).

DRUGGroup L (Control)

peribulber injection of lidocaine 2٪ (4 ml) + Normal Saline (1 ml).

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) physical status I-III patients -enrolled for elective vitreoretinal procedures under peribulbar block.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Onset of Akinesiainvestigator assess muscle tone immediately after start of anesthesia and every 15 minute up to end of surgeryonset of muscle paralysis (loss of muscle tone)

Countries

Egypt

Contacts

CONTACTwaleed adel Ahmed, lecturer
waleed.salama@med.sohag.edu.eg+201006392210
CONTACTahmed hamody hasan, assistant professor
Hamodyanesthesia@gmail.com01001752726

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026