NCT03397069

Midazolam Additive to Local Anesthetic in Peribulbar Block

Efficacy of Midazolam Addition to Local Anesthetic in Peribulbar Block. Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Al Jedaani Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Postoperative Pain
• Cataract
• Local Anaesthetic Complication
• Midazolam

Interventions

Type	Name	Description
PROCEDURE	Peribulbar block (control)	The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen. After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.
PROCEDURE	Peribulbar block(M1)	The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen. After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.
PROCEDURE	Peribulbar block(M2)	The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen. After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2018-01-11
• Last updated: 2018-08-14

Locations

1 site across 1 country: Saudi Arabia