NCT07519694

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

Not yet recruiting NA Last updated 9 April 2026

What this trial tests

NA trial testing · Group M (Midazolam): in Vitreoretinal Surgery in 90 participants. Not yet recruiting.

Timeline

1 May 2026

Primary endpoint
15 June 2026

15 June 2026

Quick facts

Lead sponsor	Sohag University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	90
Start date	1 May 2026
Primary completion	15 June 2026
Estimated completion	15 June 2026
Sites	1 location across Egypt

Drugs / interventions tested

• · Group M (Midazolam):
• · Group C (Cisatracurium):
• Group L (Control)

Conditions studied

• Vitreoretinal Surgery — all drugs for Vitreoretinal Surgery →

Sponsor

Sohag University

Who can join

Adults 18 to 70, any sex, with Vitreoretinal Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.