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.: PACTR202204650206424 Date of Approval: 14/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the safety and efficacy of combination of neostigmine and ketorolac added to reduced local anesthetic mixture dose through medial canthus injection in vitrectomy surgery
Official scientific title Evaluation of the safety and efficacy of combination of neostigmine and ketorolac added to reduced local anesthetic mixture dose through medial canthus injection in vitrectomy surgery
Brief summary describing the background and objectives of the trial Regional anesthesia is preferred for eye surgery because of its safety especially in elderly patients who are candidates for ophthalmic surgeries and are more liable for anesthetic complications. The medial canthus technique represents the safest approach regarding possibility to injure important structures such as nerves, arteries, and muscles. Local anesthetic mixtures may be toxic and may cause several complications especially if used in high volume or concentration. Neostigmine is a parasympathomimetic increases the level of acetylcholine leading to activation of cholinergic-mediated antinociception by activation of NO-CGMP pathway, which leads to prolongation of analgesia. Ketorolac is a nonsteroidal anti-inflammatory drug, which provides analgesia by inhibiting prostaglandin synthesis. When used as adjuvant to local anesthetics, it produces longer duration and better quality of analgesia during peripheral nerve block. This study will be conducted to evaluate the safety and efficacy of adding a combination of ketorolac and neostigmine to reduced dose of local anesthetic mixture through medial canthus injection to reduce the incidence of local anesthetic-induced toxic effects during vitrectomy surgeries.
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 16/04/2022
Actual trial start date
Anticipated date of last follow up 16/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
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 a randomization table created by a computer software program 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
Control Group saline plus peribulbar block anesthesia before the surgery peribulbar block in the form of single injection at the medial canthus (2.5 ml of lidocaine 2%, 75 units of hyaluronidase, 3.5 ml of bupivacaine 0.5% added to that 1.5 ml of normal saline) 25 Active-Treatment of Control Group
Experimental Group neostigmine plus ketorolac before the surgery peribulbar block in the form of single injection at the medial canthus (2.5 ml of lidocaine 2%, 75 units of hyaluronidase, 3.5 ml of bupivacaine 0.5% added to that 50 µg/ml of neostigmine plus 4 mg/ml of ketorolac) 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients (aged 25-65 years) Axial length ranging from 20 to 29 Undergoing vitrectomy surgery American Society of Anesthesiologists physical status I or II Uncooperative patients Patients who cannot lie flat for the duration of the surgery as those with skeletal problems Patients with severe coagulation disorders Patients with bradycardia or bronchial asthma Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 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 27/03/2022 Research institute of Ophthalmology Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2 El Ahram Street Giza 12557 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hemodynamic parameters - heart rate, blood pressure, oxygen saturation every 10 minutes from the beginning of anesthesia till the end of the surgery
Primary Outcome Onset of sensory block from the time of injection till complete loss of sensation
Primary Outcome Duration of the sensory block from the time of sensory loss till the beginning of sensation to return
Primary Outcome Onset of akinesia from the time of injection till complete loss of movement
Primary Outcome Duration of akinesia from the time lo loss of movement till full return of movement
Secondary Outcome Surgeon satisfaction at the end of the surgery
Secondary Outcome Patient satisfaction at the end of the surgery
Secondary Outcome Time of the 1st analgesic dose required and adverse events postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Research institute of Ophthalmology 2 El Ahram Street Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mayada Khairy 2 El Ahram Street Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research institute of Ophthalmology 2 El Ahram Street Giza Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mayada Mohamad mayada.khairy55@gmail.com +201224883922 2 El Ahram Street
City Postal code Country Position/Affiliation
Giza Egypt Department of Anesthesia Research institute of Ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Mayada Mohamad mayada.khairy55@gmail.com +201224883922 2 El Ahram Street
City Postal code Country Position/Affiliation
Giza Egypt Department of Anesthesia Research institute of Ophthalmology
Role Name Email Phone Street address
Public Enquiries Iman Sobhy iman.sobhy333@gmail.com +201225403093 2 El Ahram Street
City Postal code Country Position/Affiliation
Giza Egypt Department of Anesthesia Research institute of Ophthalmology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the de-identified individual participants data. All datasets generated and/or analyzed during the current study will be available from the corresponding author on reasonable request. This will begin 12 months and end 24 months following publication of the manuscript. Study Protocol Starting 12 months and ending 24 months following publication of the manuscript Data will be available through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
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