Midazolam Additive to Local Anesthetic in Peribulbar Block
- Conditions
- Local Anaesthetic ComplicationCataractMidazolamPostoperative Pain
- Interventions
- Procedure: Peribulbar block(M1)Procedure: Peribulbar block (control)Procedure: Peribulbar block(M2)
- Registration Number
- NCT03397069
- Lead Sponsor
- Al Jedaani Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group M1 Peribulbar block(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 C(control) Peribulbar block (control) Peribulbar block without midazolam (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml) Group M2 Peribulbar block(M2) Peribulbar block with midazolam 100 µg(peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml
- Primary Outcome Measures
Name Time Method Quality of the sensory and motor block 6 hours 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)
- Secondary Outcome Measures
Name Time Method local or systemic complications 6 hours sub-conjunctival hematoma, itching, ecchymosis, diplopia, blindness, nausea, vomiting, dry mouth, and hypotension, were recorded.
Onset and duration of block 6 hours 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.
Analgesia 4 hours postoperative 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
Trial Locations
- Locations (1)
Al Jedaani group of hospitals
🇸🇦Jeddah, Meccah, Saudi Arabia