Efficacy and Safety of Adding Atracurium to Percaruncular Block for High Myopes Undergoing Cataract Surgery
NCT03243500 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2017-08-09
Summary
There are several local anesthetic techniques available for cataract surgery and the choice depends on patient, surgical and operator factors. The eyes of patients with axial myopia (the eye globe is abnormally elongated) have thin wall (sclera), limited space for needle insertion for local anesthetic injection between the globe and the orbit and out-pouching of the back of the eye (staphyloma). These factors increased the risk of perforation following conventional needle techniques of eye block The current study technique is per-caruncular injection (the needle insertion site is between the nasal side of the globe and bony orbit) which may provide a safer alternative to the conventional needle techniques for myopic patients. The space of injection is devoid of blood vessels moreover, myopic staphylomata are infrequently located on the nasal side of the globe.
Local injection of muscle relaxant added to local anesthetic solution may provide earlier onset of eye muscle paralysis thus earlier onset of favorable surgical condition than local anesthetic solution alone.
The current study will demonstrate the effect of adding low dose atracurium (a muscle relaxant) to local anesthetic mixture in providing early onset of eye muscle paralysis and favorable surgical condition in per-caruncular technique of eye block in high myopes undergoing cataract surgery.
Conditions
- Quality of Ocular Akinesia (Onset and Duration)
Interventions
- DRUG
-
Atracurium
5mg in 1 ml normal saline
- DRUG
-
Lidocaine 2%
- DRUG
-
Bupivacaine 0.5%
- DRUG
-
hyaluronidase powder
1500 iu powder diluted in 2 vial lidocaine 20 ml resulting 37.5 IU/ml lidocaine and 93.7 / 2.5 ml lidocaine or 15.6 IU/ml of the 6 ml solution
- PROCEDURE
-
per-caruncular peribulbar injection
The patient will lie in a supine position and the eyes are in the neutral position. The needle (25 Gauge (G), 25 mm) insertion point will be just medial to the caruncle, directly perpendicular to the face and parallel to the medial orbital wall to 15-20 mm depth. After negative aspiration the already chosen local anesthetic mixture will be injected slowly. During injection, the globe will be palpated with one finger and tension in the lids will be tested frequently, if the lids become tense or if the tension is felt to rise in the globe, the injection will be stopped. After injection, external compression with Honan balloon inflated to 20-30 mm Hg will be applied for 10 minutes and will be removed every 2 minutes to test akinesia and anesthesia
Sponsors & Collaborators
-
Kasr El Aini Hospital
lead OTHER
Principal Investigators
-
nazmy e seif, md · lecturer at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt
-
ashraf m Amin, md · professor at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt
-
Mahmoud m Soliman, md · MD and professor at Ophthalmology Department, Cairo University, Egypt.
-
maha m Ismail, md · MD and assistant professor at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt
-
Maha M Ahmad, md · assistant lecturer at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-01
- Primary Completion
- 2016-05-01
- Completion
- 2016-05-01
Countries
- Egypt
Study Locations
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