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

NCT07519694 | Not Yet Recruiting DMC

• 1 other identifier: soh-med-25-10----18PD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitreoretinal Surgery

Keywords

Ophthalmic anesthesia.; Vitreoretinal surgery,

Outcome Measures

Primary Outcomes (1)

• Onset of Akinesia

  onset of muscle paralysis (loss of muscle tone)

  investigator assess muscle tone immediately after start of anesthesia and every 15 minute up to end of surgery

Study Arms (3)

· 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).

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).

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).

Drug: · Group C (Cisatracurium):

Interventions

· 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 C (Cisatracurium): lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (

Group L (Control) DRUG

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

· Group L (Control): lidocaine 2٪ (4 ml) + Normal Saline (1 ml).

· Group M (Midazolam): DRUG

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

Group M (Midazolam): lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Suhag faculty of medicine

Sohag, Sohag Governorate, 0123, Egypt

Location

MeSH Terms

Interventions

Midazolam; cisatracurium

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

waleed adel Ahmed, lecturer

CONTACT

+201006392210; waleed.salama@med.sohag.edu.eg

ahmed hamody hasan, assistant professor

CONTACT

01001752726; Hamodyanesthesia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia and intensive care

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: April 9, 2026
• Study Start: May 1, 2026
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

EG (1)