Midazolam Additive to Local Anesthetic in Peribulbar Block

NCT03397069 | Completed

• 1 other identifier: AlJedaaniH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

peribubar block - midazolam

Outcome Measures

Primary Outcomes (1)

• Quality of the sensory and motor block

  The quality of the sensory and motor block was assessed using the Ocular Anesthesia Scoring System (OASS). Patients were categorized into three groups according to the quality of the block and level of anesthesia achieved: poor (0-3), average (4-9) and good block (10-14)

  6 hours

Secondary Outcomes (3)

• Onset and duration of block

  6 hours

• Analgesia

  4 hours postoperative

• local or systemic complications

  6 hours

Study Arms (3)

Group C(control)

PLACEBO COMPARATOR

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

Procedure: Peribulbar block (control)

Group M1

EXPERIMENTAL

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

Procedure: Peribulbar block(M1)

Group M2

EXPERIMENTAL

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

Procedure: Peribulbar block(M2)

Interventions

Peribulbar block (control) 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.

Also known as: Peribulbar block without midazolam

Group C(control)

Peribulbar block(M1) 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.

Also known as: Peribulbar block with midazolam 50ug

Group M1

Peribulbar block(M2) 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.

Also known as: Peribulbar block with midazolam 100ug

Group M2

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Jedaani Hospital: lead

Study Sites (1)

Al Jedaani group of hospitals

Jeddah, Meccah, 21462/7500, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 30627737 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Cataract

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: January 11, 2018
• Study Start: January 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-01

Locations

SA (1)