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.: PACTR201506001151337 Date of Approval: 28/05/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title subtenon dexmedetomidine in vitreoretinal surgery
Official scientific title Effect of Subtenon dexmedetomidine on perioperative analgesia in vitreoretinal surgery
Brief summary describing the background and objectives of the trial Vitreoretinal (VR) surgery is associated with moderate to severe postoperative pain. The study aimed to assess the effectiveness and safety of sub-Tenon dexmedetomidine for providing intraoperative and postoperative analgesia in patients undergoing VR surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Post-operative pain after vitreoretinal surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/03/2014
Actual trial start date 08/03/2014
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
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 by computer programe Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacaine 0.5%+lidocaine2% 3-5 ml single dose mixture of bupivacaine0.5%+lidocaine2% 30 Active-Treatment of Control Group
Experimental Group dexmeditomidine+bupivacaine+lidocaine 3-5 ml single dose dexmedetomidine0.5mic/kg+bupivacaine0.5%+lidocaine2% 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA grade I¿III and aged 18¿70 years of both sex scheduled for vitreoretinal surgery with sub-Tenon¿s anesthesia the usual contraindications for regional anesthesia, coagulation abnormalities, impaired mental status, uncontrolled glaucoma, recent surgical procedure on the same eye, allergy to the studied drugs and refusal of the patient. 18 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
No 04/07/2015 medical ethical comitte of menofiya facculty of medicine
Ethics Committee Address
Street address City Postal code Country
3, yassin abdelghafar street shibin elkoom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain score at 1,2,4,6,8,12 and 24 hours after end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menofiya university hospital 3, yassin abdelghafar street shibin elkoom 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
osama elmorsy 3, yassin abdelghafar street shibin elkoom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt lecturer of anesthesia, icu, menofiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries osama elmorsy osamaelmorsy@yahoo.com 00201227968203 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt lecturer of ophthalmology, menofiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt lecturer of anesthesia, icu, menofiya faculty of medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information