Efficacy and Safety of Adding Atracurium to Percaruncular Block for High Myopes Undergoing Cataract Surgery

NCT03243500 | Completed Phase 4 DMC

• 1 other identifier: 14/9/2014
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

atracurium; high myopes; percaruncular; phacoemulsification; medial canthal; ophthalmic regional anesthesia

Outcome Measures

Primary Outcomes (1)

• assessing the quality of akinesia (onset and duration) of low dose atracurium added to lidocaine, bupivacaine and hyaluronidase mixture in Percaruncular peribulbar block

  This will be achieve by assessing ocular movement score (OMS) every 2 minutes by asking the patient to move his/her eye in four directions; up, down, medially and laterally and the movement in each direction is given a score from 0 to 2 as follows: movement more than 2 mm will be given a score of 2, 1-2 mm movement will be given a score of 1 and no movement will be given a score of 0. A total Score of 2 or less will be considered adequate akinesia for surgery. Also, eyelid movement score will be assessed by asking the patient to open his/her eye widely followed by squeezing them maximally. A full movement will be given a score of 2, the flickering will be given a score of 1 and no movement will be given a score of 0.

  from onset of ocular akinesia up to 24 hours postoperatively

Study Arms (2)

Group C

SHAM COMPARATOR

2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase powder 15 IU/ml 1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.

Drug: Lidocaine 2%; Drug: Bupivacaine 0.5%; Drug: hyaluronidase powder; Procedure: per-caruncular peribulbar injection

Group A

ACTIVE COMPARATOR

5 mg atracurium 2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase 15 IU/ml 1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.

Drug: Atracurium; Drug: Lidocaine 2%; Drug: Bupivacaine 0.5%; Drug: hyaluronidase powder; Procedure: per-caruncular peribulbar injection

Interventions

Atracurium DRUG

5mg in 1 ml normal saline

Also known as: atracurium besylate

Group A

Lidocaine 2% DRUG

Also known as: lidocaine hydrochloride 2%

Group A; Group C

Bupivacaine 0.5% DRUG

Also known as: Sunnypivacaine 0.5%

Group A; Group C

hyaluronidase powder DRUG

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

Also known as: Omnidase 1500iu Injection

Group A; Group C

per-caruncular peribulbar injection PROCEDURE

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

Also known as: medial canthal block

Group A; Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III
• high myopia (axial length 26mm or more)

You may not qualify if:

• Pregnant patients.
• ASA physical status \>III.
• Axial length less than 26 mm.
• Contraindication of regional anesthesia:
• Absolute contraindications: Patient refusal to participate in the study, Local anesthetic allergy and Infection/marked orbital inflammation or, Relative contraindications: unable to lie flat for a sufficient length of time, Confusion or psychiatric illness, communication difficulties, bleeding diathesis or taking anticoagulants, Previous scleral buckling or space-occupying lesions within the orbit

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Atracurium; Lidocaine

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• nazmy e seif, md

  lecturer at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt

  STUDY DIRECTOR

• ashraf m Amin, md

  professor at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt

  STUDY CHAIR

• Mahmoud m Soliman, md

  MD and professor at Ophthalmology Department, Cairo University, Egypt.

  STUDY DIRECTOR

• maha m Ismail, md

  MD and assistant professor at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt

  STUDY DIRECTOR

• Maha M Ahmad, md

  assistant lecturer at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer - Anesthesia, pain management and surgical ICU department

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 9, 2017
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

EG (1)