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

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ClinicalTrials.gov Identifier: NCT03243500
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Maha Mostafa Ahmad, MD, Kasr El Aini Hospital

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.


Condition or disease Intervention/treatment Phase
Quality of Ocular Akinesia (Onset and Duration) Drug: Atracurium Drug: Lidocaine 2% Drug: Bupivacaine 0.5% Drug: hyaluronidase powder Procedure: per-caruncular peribulbar injection Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Low Dose Atracurium Added to Lidocaine, Bupivacaine and Hyaluronidase Mixture in Percaruncular Peribulbar Anesthesia for High Myopes Undergoing Phacoemulsification: A Randomized Controlled Trial.
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : May 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Group C

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%
Other Name: lidocaine hydrochloride 2%

Drug: Bupivacaine 0.5%
Other Name: Sunnypivacaine 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
Other Name: Omnidase 1500iu Injection

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
Other Name: medial canthal block

Active Comparator: Group A

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
5mg in 1 ml normal saline
Other Name: atracurium besylate

Drug: Lidocaine 2%
Other Name: lidocaine hydrochloride 2%

Drug: Bupivacaine 0.5%
Other Name: Sunnypivacaine 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
Other Name: Omnidase 1500iu Injection

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
Other Name: medial canthal block




Primary Outcome Measures :
  1. assessing the quality of akinesia (onset and duration) of low dose atracurium added to lidocaine, bupivacaine and hyaluronidase mixture in Percaruncular peribulbar block [ Time Frame: from onset of ocular akinesia up to 24 hours postoperatively ]

    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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243500


Locations
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Egypt
Kasr Alaini Hospital
Cairo, Egypt, 11562
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Study Director: nazmy e seif, md lecturer at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt
Study Chair: ashraf m Amin, md professor at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt
Study Director: 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
Principal Investigator: Maha M Ahmad, md assistant lecturer at Anesthesia, Pain Management and Surgical ICU Department, Cairo University, Egypt.

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Responsible Party: Maha Mostafa Ahmad, MD, Assistant Lecturer - Anesthesia, pain management and surgical ICU department, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03243500     History of Changes
Other Study ID Numbers: 14/9/2014
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maha Mostafa Ahmad, MD, Kasr El Aini Hospital:
atracurium
high myopes
percaruncular
phacoemulsification
medial canthal
ophthalmic regional anesthesia
Additional relevant MeSH terms:
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Lidocaine
Bupivacaine
Atracurium
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents