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.: PACTR202401546543440 Date of Approval: 04/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized control study to assess the efficacy of sphenopalatine ganglion block in patients with postdural puncture headache
Official scientific title A randomized control study to assess the efficacy of sphenopalatine ganglion block in patients with postdural puncture headache
Brief summary describing the background and objectives of the trial Current treatment of postural puncture headache includes epidural blood patch (EBP), which is invasive and may result in rare but severe complications. Sphenopalatine ganglion block is suggested as a simple, minimally invasive treatment for postural puncture headache. We aimed to investigate the analgesic effect of a transmural sphenopalatine ganglion block .nnd the aim of this study is to detect the effective of sphenopalatine block in treatment of postural puncture headheb
Type of trial CCT
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 Diagnosis / Prognosis
Anticipated trial start date 05/09/2023
Actual trial start date 20/09/2023
Anticipated date of last follow up 10/01/2024
Actual Last follow-up date 30/01/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 40
Recruitment status Active, not recruiting
Publication URL jssub@ekb.eg
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group B will undergone sphenopalatine block once after receiving spinal anesthesia and the patients who suffering from postdural puncture headache will start with fluid infusion and analgesia if headache persists will start sphenopalatine blok 20
Control Group Group A 1.5g pf paracetaml for 24h after spinal anesthesia patients who suffering from postdural puncture headache will start with anelgesia 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients suffering from postdural puncture headache after spinal anesthesia not responding to usual reatment patients with coagulopathy.,nasal septum deviation ,polyp, history of nasal bleeding and allergy to local anesthetics Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Female
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 20/08/2023 Research Ethics Committee Decision
Ethics Committee Address
Street address City Postal code Country
farid nada street Benha 13511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity in upright position 30 minute after block
Secondary Outcome frequency of analgesia taken 1h.7h,
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Farid Nada street Benha 13516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha faulty of medicine Fared nada street Benha 13511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha faculty of medicine Farid nada sreet Benha 13511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zainb Mohammed zeinabmewes@gmail.com 00201221974062 Benha kaphr el gazar
City Postal code Country Position/Affiliation
Benha 13511 Egypt iecture of anesthesia and surgial icu
Role Name Email Phone Street address
Public Enquiries Ahmed Mostafa basaahmed@yahoo.com 00201005204130 20 EZZ EJDIN OMAR STREET
City Postal code Country Position/Affiliation
Giza 12111 Egypt professor of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim saadibrahim@yahoo.com 201029286117 Oman street.Elmohandseen
City Postal code Country Position/Affiliation
Giza 12111 Egypt professor of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article. After de identification ( text. tables ,figures) other documentation will be available like study protocol .the data will be available immediately following publiation Clinical Study Report 3 months it is open request type, type of data analysis is predictive. Proposal should be directed to enaswageh@yahoo.com to gain access. Data requestors will need to sign to data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.bu.edu.eg 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