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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243500 on ClinicalTrials.gov