Midazolam Additive to Local Anesthetic in Peribulbar Block

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Cataract; Local Anaesthetic Complication; Midazolam
• Intervention / Treatment: Procedure: Peribulbar block (control); Procedure: Peribulbar block(M1); Procedure: Peribulbar block(M2)

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Meccah
    • Jeddah, Meccah, Saudi Arabia, 21462/7500
      • Al Jedaani group of hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Group C(control); Peribulbar block without midazolam (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml)	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.; Other Names: Peribulbar block without midazolam
EXPERIMENTAL: 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)	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.; Other Names: Peribulbar block with midazolam 50ug
EXPERIMENTAL: 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	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.; Other Names: Peribulbar block with midazolam 100ug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset and duration of block	The onset of motor block (globe akinesia), sensory block, and lid akinesia (ptosis). Were recorded from the time of injection of (LAS) until complete globe akinesia, a disappearance of sensation, and complete lid akinesia (ptosis). Duration of globe akinesia was recorded till recurrence of muscle movements (score 8). Similarly, the return of sensation to the globe was assessed by digital spear pressure at the limbus.	6 hours
Analgesia	Postoperative pain was assessed at 30 minutes' intervals utilizing verbal rating scale (VAS) on a scale of 0 to 10 (where 0 means no pain and 10 means the worst imaginable pain) for a period of 4 hours postoperative or until first analgesic request	4 hours postoperative
local or systemic complications	sub-conjunctival hematoma, itching, ecchymosis, diplopia, blindness, nausea, vomiting, dry mouth, and hypotension, were recorded.	6 hours

Collaborators and Investigators

• Sponsor: Al Jedaani Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (ACTUAL): January 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: peribubar block - midazolam
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: AlJedaaniH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No