Midazolam Additive to Local Anesthetic in Peribulbar Block

NCT ID: NCT03397069

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group C(control)

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

Group Type: PLACEBO_COMPARATOR

Peribulbar block (control)

Intervention Type: PROCEDURE

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.

Group M1

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

Group Type: EXPERIMENTAL

Peribulbar block(M1)

Intervention Type: PROCEDURE

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.

Group M2

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

Group Type: EXPERIMENTAL

Peribulbar block(M2)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Peribulbar block without midazolam; Peribulbar block with midazolam 50ug; Peribulbar block with midazolam 100ug

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al Jedaani Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Al Jedaani group of hospitals

Jeddah, Meccah, Saudi Arabia

Countries

Saudi Arabia

References

Ibrahim M, Gomaa E. Efficacy of midazolam addition to local anesthetic in peribulbar block : Randomized controlled trial. Anaesthesist. 2019 Mar;68(3):143-151. doi: 10.1007/s00101-018-0525-3. Epub 2019 Jan 9.

Reference Type: DERIVED

PMID: 30627737 (View on PubMed)

Other Identifiers

AlJedaaniH

Identifier Type: -

Identifier Source: org_study_id