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.: PACTR202001752279176 Date of Approval: 13/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study of different doses of dexmedatomidine with bupivacaine in ultrasound guided greater auricular nerve block as supplementary to general anesthesia for postoperative tympanomastoid surgery
Official scientific title A comparative study of different doses of dexmedatomidine with bupivacaine in ultrasound guided greater auricular nerve block as supplementary to general anesthesia for postoperative tympanomastoid surgery
Brief summary describing the background and objectives of the trial Induction of general anesthesia will be as followed by greater auricular nerve block will by ultrasound The surgery was allowed to start 10 min after the block had been administered After completion of surgery Post-operative pain will be assessed using visual analogue pain scale (VAS) hourly for 24 hours.
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 greater auricular nerve block
Anticipated trial start date 23/12/2019
Actual trial start date 23/12/2019
Anticipated date of last follow up 23/01/2020
Actual Last follow-up date 02/05/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 120
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 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 greater auricular nerve block control group will receive general anesthesia only with 5ml (4ml o.25% bupivacaine and 1ml normal saline at greate auricular nerve single shot control group will receive general anesthesia only with 5ml (4ml o.25% bupivacaine and 1ml normal saline) at greate auricular nerve Post-operative pain will be assessed using visual analogue pain scale (VAS) hourly for 24 hours. 20 Dose Comparison
Experimental Group greater auricular nerve block receive general anesthesia and ultrasound guided greater auricular nerve block with 5ml (4ml o.25% bupivacaine added to 50ugdexmedetomidine in 1ml of normal saline). single shot receive general anesthesia and ultrasound guided greater auricular nerve block with 5ml (4ml o.25% bupivacaine added to 50ugdexmedetomidine in 1ml of normal saline). Post-operative pain will be assessed using visual analogue pain scale (VAS) hourly for 24 hours. 20
Experimental Group greater auricular nerve block receive general anesthesia combined with ultrasound guided greate auricular nerve block with 5ml (4ml bupivacaine o.25% added to it 100 ug dexmedetomidine in 1ml of normal saline.) single shot receive general anesthesia combined with ultrasound guided greate auricular nerve block with 5ml (4ml bupivacaine o.25% added to it 100 ug dexmedetomidine in 1ml of normal saline.) Post-operative pain will be assessed using visual analogue pain scale (VAS) hourly for 24 hours. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA l or ASA ll allergy to the used local anesthetic , allergy to any used drugs , coagulopathy , infection in the skin site of the block. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 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 22/12/2019 Ethical commiittee . department of anesthsiology . intensive care and pain manegement .faculty of medicine menofia university
Ethics Committee Address
Street address City Postal code Country
shebin elkom shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS score postoperative from discha-rge from PACU to 24hour postoperativ
Secondary Outcome side effects (nausea and vomiting),hypotension,additional analgesic requirements,and Ramsey Sedation Scores (RSS), surgical field qualit will recorded postoperative from discha-rge from PACU to 24hour postoperativ
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medecine . menofia university shebin elkom shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Noha abd allah elsayed afify shebin elkom shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine . menofia university shebin elkom shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nevien mostafa soliman Alexandria Alexandria 21500 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer in anesthesiology department
Role Name Email Phone Street address
Public Enquiries noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer in anesthesiology department
Role Name Email Phone Street address
Scientific Enquiries noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer in anesthesiology department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes اقر انا اننى موافق على حقن اللعصب الأذني الأكبر كمكمل للتخدير العام وذلك ليسكين الام ما بعد جراحة طبلة الأذن وتم توضيح الاثار الجانبيه المتعلقه سواء بهذا الحقن اوالمواد المستخدمه وتم ايضاح هذا دون اجهام منى بذلك. المقر بما فيه Patient name : I agree to inject the greater auricle nerve as a supplement to general anesthesia, so as to relieve the pain after the eardrum surgery, and the side effects related to this injection or the materials used were clarified, and this was clarified without me being tempted to do so. signature Study Protocol within two monthes controlled access
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