Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201606001658235 Date of Approval: 02/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between the effects of adding Cisatracurium versus hyaluronidase to Levobupivacaine in single injection peribulbar block for cataract surge
Official scientific title Comparison between the effects of adding Cisatracurium versus hyaluronidase to Levobupivacaine in single injection peribulbar block for cataract surgery
Brief summary describing the background and objectives of the trial The great majority of patients undergoing cataract surgery are elderly who have several co-morbidities, so regional anesthesia is the preferred one. Because of its safety, ease to perform and its efficacy, the peribulbar is the most common anesthesia used for Cataract surgery (1). When local anesthetics used alone for peribulbar block, there is may be delayed akinisia and delayed corneal anesthesia and frequent need for block supplementation (2, 3). So several adjuvant can be used with to improve the quality of peribulbar block as hyaluronidase (4), sodium bicarbonate (5), clonidine (6) and neuromuscular blocking agents (7,8). Neuromuscular blocking drugs, such as atracurium has been used in peribulbar block as an adjuvant to the local anesthetic mixture to improve the quality of the block (8). cis-Atracurium in combination with a local anesthetic solution was used in this study for the purpose of accelerating total immobility of the eyes, ocular muscle paresis. Hyaluronidase is added to local anesthetics for ophthalmic blocks. It causes wide spread of the injected solution and improve the quality of the block. (9, 10) So the aim of our study will be to compare the effects of Hyaluronidase and cis-Atracurium on the spread of local anesthetic solution used for peribulbar block and on the quality of the block. Also we will evaluate the related complications and patients satisfaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Eye Diseases,Peribulbar block for cataract surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/01/2015
Actual trial start date 16/06/2015
Anticipated date of last follow up 01/08/2016
Actual Last follow-up date 01/08/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hyaluronidase group 4ml 0.5% levobupivacaine (Chirocaine, Abbott Laboratories, Elverum, Norway) plus 3ml lidocaine 2% plus 1ml hyaluronidase (15 IU/mL) (Hyalase® 1500 IU, Wockhardt, UK once before surgery patients of this group will receive 4ml 0.5% levobupivacaine (Chirocaine, Abbott Laboratories, Elverum, Norway) plus 3ml lidocaine 2% plus 1ml hyaluronidase (15 IU/mL) (Hyalase® 1500 IU, Wockhardt, UK). 30
Experimental Group cisatracurium group 4 ml 0. 5% levobupivacaine (Chirocaine, Abbott Laboratories, Elverum, Norway) plus 3ml lidocaine 2% plus cisatracurium (1mg) in 1 ml saline. once before surgery patients of this group will receive 4 ml 0. 5% levobupivacaine (Chirocaine, Abbott Laboratories, Elverum, Norway) plus 3ml lidocaine 2% plus cisatracurium (1mg) in 1 ml saline 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients American Society of Anesthesiologists (ASA) I-III, scheduled for elective cataract surgery under peribulbar anesthesia previous allergic reaction to local anesthetics, mental illness, age younger than 18 years, patients refusing LA, patients with a single eye, hepatic dysfunction, anticoagulation therapy, patients who were having active infection difficulty in communication, orthopnea, severe uncontrolled hypertension, extra-ocular muscles or eyelid abnormalities, previous intraocular injury or surgery, patients with posterior synechia, and ocular axial length more than 25 mm. anxious patients and those with communication problems (impaired hearing) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/05/2016 Tanta University, Faculty of medicine, Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Algeish Tanta 31512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the appearance of T sign done before injection of local anesthetics and after injection of local anesthetics at 1, 5 and 10 minutes
Secondary Outcome Time for adequate conditions to start the surgery The ocular motility will be measured before blocking, then 3, 5, and 10 minutes after it.
Secondary Outcome sensory block duration in the postoperative period every hour
Secondary Outcome motor block duration in the postoperative period every hour
Secondary Outcome postoperative pain at the end of surgery and every hour up to 2 h and then at 6 h and 8 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals Algeish Tanta 31512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no source for funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine, tanta university tanta, methabash Tanta 31512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed M Abu Elyazed algeish Tanta 31512 Egypt
Mona M Mogahid algeish Tanta 31512 Egypt
Mohamed A Nassif algeish Tanta 31512 Egypt
Mohamed S Abdghafear algeish Tanta 31512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed AbdElghafear mohamedghafar76@yahoo.com 00201005406231 algeish
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, tanta university
Role Name Email Phone Street address
Public Enquiries Mohamed AbuElyazed mohd_yazed75@yahoo.com +20403462350 tanta, methabash
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, tanta university
Role Name Email Phone Street address
Scientific Enquiries Mohamed AbuElyazed mohd_yazed75@yahoo.com +20403462350 algheish
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, tanta university
REPORTING
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