Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: · Group M (Midazolam):, · Group C (Cisatracurium):, Group L (Control).
- Who it may be relevant to
- Registry conditions: Vitreoretinal Surgery. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery (Prospective Comparative Randomized Controlled Trial
Overview
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). - Drug Group L (Control)
peribulber injection of lidocaine 2٪ (4 ml) + Normal Saline (1 ml).
Primary outcome measures
- Onset of Akinesia [Time frame: investigator assess muscle tone immediately after start of anesthesia and every 15 minute up to end of surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Suhag faculty of medicine — Sohag
Identifiers
NCT: NCT07519694 · soh-med-25-10----18PD