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.: PACTR202203682996126 Date of Approval: 23/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.
Official scientific title The role of Intrathecal Neostigmine as an Adjuvant to Bupivacaine in Ameliorating Post-Dural Puncture Headache for Elective Caesarian Section: A Prospective Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial The objective of the current study is to investigate the possible prophylactic role of intrathecal neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section. Intravenous neostigmine was recently reported as an effective treatment for PDPH for parturients after intrathecal (IT) block which is postulated to be through its central effects on CSF secretion and cerebral vascular tone modulation. Intrathecal neostigmine has been investigated widely and found to be an effective adjuvant to bupivacaine for postoperative analgesia.
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 Prevention
Anticipated trial start date 04/04/2022
Actual trial start date 25/04/2022
Anticipated date of last follow up 03/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 722
Actual target sample size (number of participants)
Recruitment status 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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neostigmine group 0.5 mg ampule (1 ml) will be diluted in 4 ml dextrose 5% to make a solution of 100 μg/ml, 0.2 ml of this solution will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % (12.5 mg) used for intrathecal injection. Only one time during an intrathecal block. Use of neostigmine 20 micrograms dose as an adjuvant with bupivacaine 12.5 mg for an intrathecal block for parturients who will be scheduled for elective cesarean section for a possible reduction of the incidence and severity of post-dural puncture headache. 361
Control Group The control group One ml of normal saline 0.9 % will be mixed with 4 ml dextrose 5 % in the five-milliliter syringe. 0.2 ml of this mixture will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % (12.5 mg) used for intrathecal injection. Just once during the intrathecal block. It's a placebo solution that will be mixed with hyperbaric bupivacaine for intrathecal blocks to maintain blinding and randomization 361 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American society association (ASA) physical status class II parturients with a single fetus who will be scheduled for an elective caesarian section by Intrathecal block. Body mass index more than or equal to 35 kg/m2. Any contraindication to Intrathecal blocks such as local infection, bleeding disorders, or parturient refusal. Allergy to neostigmine or other drugs will be used in the study. Long-term opioid use. A history of chronic pain, migraine, cluster headache. Digestive problems with nausea and vomiting; cognitive dysfunction or memory disorders. Significant renal, hepatic, and cardiovascular diseases. History of urinary retention or bronchial asthma. Inadequate or failed Intrathecal block. Complicated pregnancy such as hypertensive disorders of the pregnancy, abnormal placenta, or uterine atony. 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 20/01/2022 Research ethics committee of faculty of medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Alexandria University, 17 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria 21526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of post-dural puncture headache Two times daily for five days after intrathecal block.
Secondary Outcome Age in years 6 hours before intervention
Secondary Outcome Weight in kilograms (kg) 6 hours before intervention
Secondary Outcome Height in meters (m) 6 hours before intervention
Secondary Outcome Body mass index in kilograms per meter square 6 hours before intervention
Secondary Outcome Duration of surgical procedure in minutes Just after completion of surgery
Secondary Outcome The number of intrathecal block attempts. Just after completion of succssecefull intrathecal block.
Secondary Outcome Post-dural puncture headache (PDPH) severity assessment by Visual Analog Score(VAS). AS 0 = no headache, and 10 = worst imaginable headache. At presentation and then two times daily for 48 hours after post dural puncture headache onset.
Secondary Outcome Neck stiffness incidence. For 48 hours after headache onset.
Secondary Outcome Percent of participants in need of an epidural blood patch with severe Intractable headache (VAS ≥ 4) and the headache is persistent for more than 48 hours with no response to conservative measures. Within 7 days after presentation.
Secondary Outcome The onset of post-dural puncture headache. Within five days of intrathecal block and at presentation of the participant,
Secondary Outcome Incidence of intraoperative nausea. After intrathecal block till completion of the surgical procedure.
Secondary Outcome Incidence of intraoperative vomiting. After intrathecal block till completion of the surgical procedure.
Secondary Outcome Incidence of postoperative nausea. Within two hours after completion of surgical procedure.
Secondary Outcome Incidence of postoperative vomiting. Within two hours after completion of surgical procedure.
Secondary Outcome Urine retention incidence. Within 24 hours of intrathecal block.
Secondary Outcome Memory and cognitive disorders incidence. Within 24 hours of intrathecal block.
Secondary Outcome Intraoperative hypotension incidence After intrathecal block till completion of the surgical procedure.
Secondary Outcome Intraoperative ephedrine dose requirements in milligrams. After intrathecal block till completion of the surgical procedure.
Secondary Outcome Intraoperative incidence of desaturation. After intrathecal block till completion of the surgical procedure.
Secondary Outcome Intraoperative incidence of respiratory depression. After intrathecal block till completion of the surgical procedure.
Secondary Outcome Intraoperative incidence of bradycardia. After intrathecal block till completion of the surgical procedure.
Secondary Outcome Intraoperative atropine dose requirements in milligrams. After intrathecal block till completion of the surgical procedure.
Secondary Outcome Intraoperative incidence of shivering. After intrathecal block till completion of the surgical procedure.
Secondary Outcome Time to the first requirements of analgesics in minutes. after intrathecal block till participant need for surgical pain relieve.
Secondary Outcome Total analgesic dose consumption in milligrams. within 24 hours after intrathecal block.
Secondary Outcome Sensory block onset. Time after intrathecal block till loss of pinprick sensation at T4 level.
Secondary Outcome Sensory block duration Time after four segment regression.
Secondary Outcome Motor block onset. Time after intrathecal block till the modified Bromage score will be 3.
Secondary Outcome Motor block duration. Time after intrathecal block till the modified Bromage score will be zero.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Hospital Faculty of Medicine, Alexandria University, 17 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria University Hospital Faculty of Medicine, Alexandria University, 17 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria 21131 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University Hospital Faculty of Medicine, Alexandria University, 17 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fayoum University Algamaa district Fayoum Egypt
Kaser Alainy University hospital Kaser Alainy Street Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Yassin hmy00@fayoum.edu.eg +201111363602 303 T, Hadaek Al-Ahram, Giza, Egypt.
City Postal code Country Position/Affiliation
Giza Egypt Associate professor Anesthesia department faculty of medicine Fayoum University.
Role Name Email Phone Street address
Public Enquiries Ahmed Alnaggar A_elnajjar00@alexmed.edu.eg +201005101836 Alnasr Street infant of green plaza, teiba towers. Al rawda building flat 201,Smouha, Alexandria, Egypt.
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anesthesia and ICU faculty of medicine Alexandria University.
Role Name Email Phone Street address
Scientific Enquiries Hisham Gamal Eldine hesham.gamal@alexmed.edu.eg +201006665018 Mohammad Farid Street, building 20th,flat 17th, Bolkly, Alexandria, Egypt.
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anesthesia and ICU faculty of medicine Alexandria University.
Role Name Email Phone Street address
Principal Investigator Ahmed Alnaggar A_elnajjar00@alexmed.edu.eg +201005101836 Alnasr Street infant of green plaza, teiba towers. Al rawda building flat 201,Smouha, Alexandria, Egypt.
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer at Anesthesia and ICU department faculty of medicine Alexandria University
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 deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose could request controlled access to the data for possible individual participant meta-analysis. The proposal may be submitted up to 36 months following article publication.
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