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.: PACTR202111686374192 Date of Approval: 19/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of adding verapamil to local anaesthetics in peribulbar block for intraoperative anaesthesia and postoperative analgesia in vitreoretinal surgery
Official scientific title The effect of adding verapamil to local anaesthetics in peribulbar block for intraoperative anaesthesia and postoperative analgesia in vitreoretinal surgery: A randomized clinical trial
Brief summary describing the background and objectives of the trial The use of regional anaesthesia in ophthalmic surgery has been much preferred because of many benefits. However, peribulbar block has several disadvantages such as slow onset, short duration, and the need of large volume which may increase the intraocular pressure. Local anaesthetics have been supplemented with several additives to minimize such disadvantages such as hyaluronidase, clonidine, and muscle relaxants. Vitreoretinal surgery has been performed under general anaesthesia. Recently different modes of local anaesthesia have been used. The most common of which is peribulbar anaesthesia. A combination of Bupivacaine 0.5% with xylocaine 2% to prolong the duration of local anaesthesia for ensuring the coverage of the whole procedure whatever the duration of surgery. Calcium plays an important role in analgesia produced by local anaesthetics; The activation of N – methyl – D – aspartate receptors may lead to calcium entry into the cells and play a role in pain formation. Thus, calcium channel blockers (e.g. verapamil) may lead to better sensory and motor block. It can potentiate analgesic action of local anaesthetic and reduce postoperative pain and analgesic consumption. Hence, this study aims to evaluate the safety and efficacy of adding verapamil to local anaesthesia (xylocaine 2% 5ml + Bupivacaine 0.5% 5ml ) for peribulbar block in Vitreoretinal surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 10/02/2021
Actual trial start date 15/03/2021
Anticipated date of last follow up 10/05/2021
Actual Last follow-up date 15/06/2021
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
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 randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Verapamil 5 mg verapamil Once Patients will receive 5 ml xylocaine 2% + 5 ml Bupivacaine 0.5% (containing 100 units of hyaluronidase) + 5 mg verapamil 40
Control Group Normal saline 2 ml normal saline Once Patients will receive 5 ml xylocaine 2% + 5 ml Bupivacaine 0.5% (containing 100 units of hyaluronidase) + 2 ml normal saline 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I, II, III Age: 30 to 70 years Vitreoretinal surgery patients ASA IV Patients with coagulopathy or on anticoagulant treatment Infection at the site of surgery Patients with posterior staphyloma Uncooperative patients Allergy to local anaesthetic agents used Patients with bronchial asthma or bradyarrhythmia Patients who refused to participate in the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 70 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 14/03/2021 Ethics Committee of the Research Institute Of Ophthalmology Our Ethics Committee does not have a special coding system but use the date as the reference number
Ethics Committee Address
Street address City Postal code Country
2 El Ahram St., Giza, Egypt Giza 12557 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Haemodynamics - heart rate, blood pressure, and oxygen saturation Before the block, after the block, and 1 hour later
Primary Outcome The onset of anaesthesia Using gentle touching of the cornea with cotton swab from time of injection till complete loss of sensation.
Primary Outcome The onset of akinesia Every minute using by a range of 0 to 4 from finishing of injection till complete akinesia.
Primary Outcome The duration of the block From time of injection till full recovery of movement.
Primary Outcome Verbal pain scores After 2 hours.
Secondary Outcome The time to the first pain medication intake Every hour.
Secondary Outcome Patient and surgeon satisfaction After the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Research Institute of Ophthalmology 2 El Ahram St. Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Iman Sobhy 2 El Ahram St. Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Institute of Ophthalmology 2 El Ahram St. Giza Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Iman Sobhy iman.sobhy333@gmail.com 00201225403093 2 El Ahram St.
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Iman Sobhy iman.sobhy333@gmail.com 00201225403093 2 El Ahram St.
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Iman Sobhy iman.sobhy333@gmail.com 00201225403093 2 El Ahram St.
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is a plan to make all collected deidentified IPD available. Study Protocol Beginning 12 months and ending 36 months following article publication. All collected deidentified IPD will be available to researchers from academic and health institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information