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.: PACTR201601001404105 Date of Approval: 28/12/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Epidura dexmedetomidine and failed back surgery syndrome
Official scientific title The effect of dexmedetomidine in lumbar epidural injection for failed back surgery syndrome
Brief summary describing the background and objectives of the trial Background: Low back pain after spinal surgeries is one the most interesting problems in pain management. Lumbar epidural steroid injection is the most commonly used intervention in managing failed back surgery syndrome. Most patients require multiple and frequent injection due to persistence of pain. Objective: To evaluate the effect of adding dexmedetomidine to lumbar epidural steroids in patients with failed back surgery syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2013
Actual trial start date 01/10/2013
Anticipated date of last follow up 01/10/2015
Actual Last follow-up date 01/12/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Randomised sinple randomization by coin tossing Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group betamethasone, bupivacaine, saline 14mg betamethasone, 1ml bupivacine 0.5%, 17ml saline single injection lubar epidural injection 25 Active-Treatment of Control Group
Experimental Group betamethasone, bupivacaine, saline, dexmedetomidine 14mg betamethasone, 1ml bupivacine 0.5%, 17ml saline, dexmedetomidine 0.5 mic/kg single injection lubar epidural injection 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients 40¿70 years old of both sexes, ASA physical status I ¿ III,were referred to the Menoufiya University outpatient pain clinic and suffering from failed back surgery syndrome. . Patients were excluded if they suffered from sacroiliac joint disease, facet joint arthritis, severe cardiopulmonary disease, uncontrolled diabetes, morbid obesity, addiction, infection, coagulation disorders and patients were on opioid medications for pain management before or during the study period. 40 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 01/02/2016 menoufiya faculty of medicine
Ethics Committee Address
Street address City Postal code Country
3, yassin abd elghafar street shibin elkoom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity measured VAS 2 weeks, 4 weeks,8 weeks and 12 weeks after injection
Secondary Outcome NSAID dose 2 weeks, 4 weeks, 8weeks and 12weeks after injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufiya faculty of medicine hospital 3,yassin abd-elghafar street shibin elkoom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufiya faculty of medicine 3, yassin abd elghafar street shibin elkoom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufiya faculty of medicine 3, yassin abd elghafar street shibin elkoom 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ashraf eskandr 63, salah salim street quesna 12334 Egypt
sadik abd elmaseeh 3, yassin abd elghafar street shibin elkoom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ashraf eskandr ameskandr@yahoo.com +201001960697 63, salah salim street
City Postal code Country Position/Affiliation
quesna 12334 Egypt lectrer of anesthesia,menoufiya university
Role Name Email Phone Street address
Public Enquiries sadik abd elmaseeh sadikelnaggar@gmail.com +201006878214 3, yassin abd elghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12334 Egypt lectrer of anesthesia,menoufiya university
Role Name Email Phone Street address
Scientific Enquiries ashraf eskandr ameskandr@yahoo.com +201001960697 63, salah salim street
City Postal code Country Position/Affiliation
quesna 12334 Egypt lectrer of anesthesia,menoufiya university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information