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.: PACTR201603001498189 Date of Approval: 29/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of intrathecal fentanyl on the incidence and/or severity of postdural puncture headache in obstetric patients
Official scientific title Effect of intrathecal fentanyl on the incidence and/or severity of postdural puncture headache in obstetric patients
Brief summary describing the background and objectives of the trial This prospective double-blinded study will be performed in El-Minia Maternity University Hospital after getting approval from the institutional ethical committee. A total of 300 obstetric patients, inclusion 1-aged between 18- 30 years, 2- non-obese (BMI ¿ 30) , 3-belonging to ASA grade I or II and undergoing elective or emergency CS under SAB will be enrolled into the study. Exclusion criteria of the patients included 1-contraindications to regional anesthesia, 2-history of migraine, 3-chronic headache, 4- psychiatric illness or neurological dysfunction; and5- patients requiring more than three attempts for lumbar puncture. They will be divided randomly into 2 groups, according to computer generated numbers, having 150 patients each. Group I will have spinal anesthesia with the 25gauge cutting spinal needle and will get 2.5 ml of 0.5% hyperbaric bupivacaine plus 0.5 ml normal saline injected intrathecally (control group). Group II will have spinal anesthesia with the 25gauge cutting spinal needle and will get 2.5 ml of 0.5% hyperbaric bupivacaine plus 25 ¿g (0.5 ml) preservative-free fentanyl. Intraoperatively, hemodynamics, arterial oxygen saturation, quality of anesthesia and any maternal or neonatal side effects will be recorded. On the 7th postoperative day, an anesthetist unaware of the intrathecal injected drugs will contact the patients through phone calls to ask for occurrence of PDPH. One week later, the patients will receive another phone call to evaluate for any signs or symptoms of a delayed-onset headache. Accordingly, if there are the typical features of PDPH, the onset, duration, severity of it and any associated symptoms will be recorded. The primary outcome will be the incidence of PDPH after addition of intrathecal fentanyl, compared to group I. The secondary outcome will be the duration, severity, and response to treatment of the headache in the two groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/04/2016
Actual trial start date 02/04/2016
Anticipated date of last follow up 04/10/2016
Actual Last follow-up date 04/10/2016
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Maternity Hospital Minia University
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 computer generated numbers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group spinal anesthesia with intrathecal preservative-free fentanyl. 25 micrograms once spinal anesthesia with the 25gauge cutting spinal needle and will get 2.5 ml of 0.5% hyperbaric bupivacaine plus 25 ¿g (0.5 ml) preservative-free fentanyl. 150
Control Group traditional spinal anaethesia 2.5 ml of 0.5% hyperbaric bupivacaine plus 0.5 ml normal saline injected intrathecally once spinal anesthesia with the 25gauge cutting spinal needle and will get 2.5 ml of 0.5% hyperbaric bupivacaine plus 0.5 ml normal saline injected intrathecally 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-aged between 18- 30 years, 2- non-obese (BMI ¿ 30) , 3-belonging to ASA grade I or II and undergoing elective or emergency CS under SAB will be enrolled into the study. 1-contraindications to regional anesthesia, 2-history of migraine, 3-chronic headache, 4- psychiatric illness or neurological dysfunction; and5- patients requiring more than three attempts for lumbar puncture. 18 Year(s) 30 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
No 20/03/2016 faculty of medicine ethical committee
Ethics Committee Address
Street address City Postal code Country
Minia University street Minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of PDPH after addition of intrathecal fentanyl, one week postoperative
Secondary Outcome duration, severity, and response to treatment of the headache in the two groups. one week postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Maternity hospital Minia University Minia University street Minia 61111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maternity Hospital Minia University Minia University street Minia 61111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maternity Hospital Minia University Minia University street Minia 61111 Egypt Hospital
Secondary Sponsor Minia University Minia University street Minia 61111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
shimaa Ismaeel Salah Eldin street Minia 61111
Reham elkateeb Taha Hussin Minia 61111
Wegdan Ali Salah Eldin street Minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wegdan Ali wegdan21122000@yahoo.com 00201002522558 Salah Eldin street
City Postal code Country Position/Affiliation
Minia 61111 Egypt lecturer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Shimaa Ismaeel shemoo.ismael@yahoo.com 00201006204692 Salah Eldin street
City Postal code Country Position/Affiliation
Minia 61111 Egypt lecturer of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Reham Elkateeb rehamelkhateeb78@yahoo.com 00201011966648 Taha Hussin
City Postal code Country Position/Affiliation
Minia 61111 Egypt lecturer of Obstetrics and Gynecology
REPORTING
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