Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery
- Conditions
- Acute Postoperative Pain
- Interventions
- Registration Number
- NCT04668456
- Lead Sponsor
- Menoufia University
- Brief Summary
The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.
- Detailed Description
Ophthalmological surgery can be performed under topical, regional or general anesthesia. Recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. Orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-Tenon's block.
The STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury.
Dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics.
Many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
- ASA grade I-III
- Aged 18-70 years
- Both sex
- Scheduled for elective phacoemulsification cataract surgery
- Coagulation abnormalities
- Impaired mental status
- Refusal of the patient
- Uncontrolled glaucoma
- Recent surgical procedure on the same eye
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group ID (iv dexmedetomidine) lidocaine 2% Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block. Group C (control group) bupivacine 0.5% Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group C (control group) Normal saline Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group SD (subtenon dexmedetomiine) Normal saline Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group C (control group) lidocaine 2% Group C (control group): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group SD (subtenon dexmedetomiine) lidocaine 2% Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group SD (subtenon dexmedetomiine) bupivacine 0.5% Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group ID (iv dexmedetomidine) bupivacine 0.5% Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block. Group SD (subtenon dexmedetomiine) Dexmedetomidine Group SD ( subtenon dexmedetomidine): received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ 0.5 μg/kg dexmedetomidine (0.5 ml) and IV infusion of saline 0.9% over 10 min. before subtenon block. Group ID (iv dexmedetomidine) Dexmedetomidine Group ID (iv dexmedetomidine): received received subtenon LA mixture of bupivacaine 0.5% (1 ml) + lidocaine 2% (1 ml)+ saline 0.9% (0.5 ml) and IV infusion of 0.5 μg/kg dexmedetomidine over 10 min. before subtenon block.
- Primary Outcome Measures
Name Time Method duration of sensory block 24 hours time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia
- Secondary Outcome Measures
Name Time Method duration of motor block 24 hours time from injection of local anesthetic to complete recovery of motor function in all ocular muscles.
Trial Locations
- Locations (3)
Sadik A Sadik
🇪🇬Shibīn Al Kawm, Menoufiya, Egypt
Ashraf magdy Eskandr
🇪🇬Shibīn Al Kawm, Menoufiya, Egypt
Osama A Elmorsy
🇪🇬Shibīn Al Kawm, Menoufiya, Egypt