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.: PACTR201804003292841 Date of Approval: 04/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Comparative study between distal and proximal ultrasound guided bilateral occipital nerve block for post dural puncture headache
Official scientific title A Comparative study between distal and proximal ultrasound guided bilateral occipital nerve block for post dural puncture headache
Brief summary describing the background and objectives of the trial To compare the pain relieving effect of ultrasound guided bilateral greater occipital nerve block at superior nuchal line versus at C2 level for post dural puncture headache.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,To compare the pain relieving effect of ultrasound guided bilateral greater occipital nerve block at superior nuchal line versus at C2 level for post dural puncture headache.
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/04/2018
Actual trial start date 05/04/2018
Anticipated date of last follow up 05/10/2018
Actual Last follow-up date 05/10/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet 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 randomisation using a radomisation 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
Experimental Group Group A 3 ml of isobaric bupivacaine and 4mg dexamethasone throughout the operation receive a distal bilateral greater occipital nerve injection of 3 ml of isobaric bupivacaine and 4mg dexamethasone at the level of superior nuchal line. 20
Experimental Group Group B 3 ml of isobaric bupivacaine and 4mg dexamethasone throughout the operation receive a proximal bilateral greater occipital nerve injection of 3 ml of isobaric bupivacaine and 4mg dexamethasone at the level of the second cervical vertebra. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with knee PDPH. 2. ASA I, II patients. 3. Both sexes included aged 15 to 50 years. 4. NRS more than 4 5. Pain is not relieved by pharmacological treatment. 1. Patient refusal 2. Anatomical anomalies 3. Previous skull surgery or trauma 4. Other types of headaches. 5. Allergy to amid local anesthetics or corticosteroids 6. Local infection or sepsis. 7. Coagulopathy or anticoagulant therapy 8. Diabetes mellitus. 9. Hypertension 15 Year(s) 50 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 02/04/2018 aswan university
Ethics Committee Address
Street address City Postal code Country
el seel street aswan 35127 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome in this study is improving in pain of post dural puncture headache (10 minutes, 6 hours, 12 hours, 24 hours, 36 hours and 24 hours), It will be assessed by numerical rating scale (NRS). 10 minutes, 6 hours, 12 hours, 24 hours, 36 hours and 24 hours
Secondary Outcome Occurrence of side effects or complications. 10 minutes, 6 hours, 12 hours, 24 hours, 36 hours and 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Aswan umiversity el seel street aswan 35127 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sherif kamal arafa el bahr street tanta 35127 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal arafa el bahr street tanta 35127 Egypt Funding Agency
Secondary Sponsor amir abozikary el sayed el seel street aswan 35127 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif kamal arafa el bahr street tanta 35127 Egypt
amir abozikary el sayed el seel street aswan 35127 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Public Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Scientific Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information