Midazolam Additive to Local Anesthetic in Peribulbar Block

Al Jedaani Hospital

Status: Completed

Conditions: Postoperative Pain; Cataract; Midazolam; Local Anaesthetic Complication

Treatments: Procedure: Peribulbar block (control); Procedure: Peribulbar block(M1); Procedure: Peribulbar block(M2)

Study type: Interventional

Funder types: Other

Identifiers

NCT03397069

AlJedaaniH

Details and patient eligibility

About

Regional eye blocks are usually preferred for ophthalmic procedures. Peribulbar block (PBB) is a safe alternative for patients undergoing cataract surgery. Many studies tried to solve this issue by means of prolonging the duration of action of the local anesthetics used. Several drugs were tried as adjuncts to local anesthetics, and their effects have been studied. Midazolam added to the list of adjuvant used in the subarachnoid or epidural block can produce analgesia, probably mediated by the benzodiazepine-Gamma Amino-Butyric Acid(GABA) receptor complex.

The investigators hypothesized that the addition of midazolam to lidocaine will improve the quality of the peribulbar block; fasten the onset and prolonging its anesthetic and analgesic duration.

Enrollment: 90 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 90 adult patients with ASA physical status I to III
• Aged 40-70 years
• Scheduled for elective extracapsular or phacoemulsification cataract surgery with peribulbar block
• No history of allergy to local anesthetics
• Axial length less than 28 mm.

Exclusion criteria

• Patient's refusal to share in the study
• communication barrier (e.g. impaired hearing, disturbed conscious level, impaired mental status)
• uncontrolled tremors
• morbidly obese patients
• allergy to lidocaine
• coagulation abnormalities
• glaucoma
• recent surgical procedure on the same eye.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Group C(control)

Placebo Comparator group

Description:

Peribulbar block without midazolam (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml)

Treatment:

Procedure: Peribulbar block (control)

Group M1

Experimental group

Description:

Peribulbar block with midazolam 50 µg (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml)

Treatment:

Procedure: Peribulbar block(M1)

Group M2

Experimental group

Description:

Peribulbar block with midazolam 100 µg(peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml

Treatment:

Procedure: Peribulbar block(M2)