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.: PACTR202203511463759 Date of Approval: 16/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of injection of intravenous ketamine on prevention of post-dural puncture headache after spinal anesthesia in patients undergoing elective cesarean section
Official scientific title Effect of injection of intravenous ketamine on prevention of post-dural puncture headache after spinal anesthesia in patients undergoing elective cesarean section
Brief summary describing the background and objectives of the trial Spinal anesthesia is the most used method for elective cesarean section due to its simplicity, reliability, and speed to achieve adequate anesthesia. Also, the likelihood of maternal pulmonary aspiration and fetal distress is minimized. Headache following dura perforation is the most important delayed event following spinal and epidural anesthesia. It is a severe, vague headache that engages the front and back of the head, spreads to the neck and shoulder, and sometimes causes a stiff neck. Ketamine is a derivative of phencyclidine used in general anesthesia, and it is the only intravenous anesthetic that has analgesic effect in low doses, and it may produce mild increase in intracranial pressure. Since post-dural puncture headache may result from intracranial pressure depletion, ketamine may be effective in this case by compensating this decrease in intracranial pressure. So, this study will be conducted to assess the efficacy and safety of intravenous low-dose ketamine in patients undergoing cesarean section under spinal anesthesia for prevention of 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 Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/04/2022
Actual trial start date
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Saline 5 minutes before the surgery After anesthesia stabilization at T4 sensory level, and about 5 minutes before the surgery, the control group is intravenously injected with normal saline (10 ml) as placebo 64 Placebo
Experimental Group Ketamine 5 minutes before the surgery After anesthesia stabilization at T4 sensory level, and about 5 minutes before the surgery, the experimental group is intravenously injected with ketamine (0.15 mg/kg in 10 ml of normal saline as a total volume) 64
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 20 – 40 years Gender: female BMI: 30 – 40 kg/m2 Height: 160 – 180 cm Elective cesarean section Hypertension, epilepsy, or coagulation disorder Allergy to the drugs used History of migraine or other types of headache Drug addiction Adult: 19 Year-44 Year 20 Year(s) 40 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 07/07/2021 Research Ethics Committee Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
Ramsis Street Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence and severity of headache at 1, 4, 12 ,24 hours post operatively
Secondary Outcome time to first analgesia, total analgesic requirement, and adverse events postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Ramsis Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ghada Refat Ramsis Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Ramsis Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ghada Refat ghada.refat444@gmail.com +201142461872 Ramsis Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Ghada Refat ghada.refat444@gmail.com +201142461872 Ramsis Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Heba Toulan heba.f.abdelaziz55@gmail.com +201221077317 Ramsis Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the individual participants data (de-identified). All datasets generated and/or analyzed during the current study will be available from the corresponding author (on reasonable request), beginning 12 months and ending 24 months following publication of the manuscript. Study Protocol beginning 12 months and ending 24 months following publication of the manuscript Data to be used for systematic reviews or meta-analyses. Data will be available through direct contact with the corresponding author.
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