Acute PainPhase 4NCT06493838
Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial
A Phase 4 study testing intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping. and Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping. in people with Acute Pain, run by Minia University.
Trial summary
Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Acute Pain
- What is being tested?
- intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping. and Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 16 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturient ladies
- Age ranges from 18 to 35 years old.
- ASA II with elective caesarean section under sub-arachnoid block
Who cannot join
- BMI >35
- Refusal to participate
- surgical complications necessitating a blood transfusion
- Emergency caesarean section
- the need for endotracheal intubation or vasopressors
- any contraindication to regional anesthesia (such as a history of persistent cephalgia, convulsions, cerebrovascular events
About this study
Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.
- Conditions
- Acute Pain
- Being tested
- intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping., Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.Drug
intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.
Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.Drug
Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | intravenous 50 mL of sterile saline 0.9% injection of 0.9% after umbilical cord clamping. Receives: Drug: intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping. |
| Neostgmine group | Active comparator | Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping. Receives: Drug: Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients with post dural puncture headache
Number of patients develop post dural puncture headache
Measured: first 5 days post-partum
Secondary outcomes (6)
Severity of post dural puncture headache
Visual analogue scale score for pain assessment. from 0 to ten. 0= no pain 1-3= mild pain....4-6= moderate pain ... 7-10= severe pain
Measured: first 5 days post-partum
onset and duration of post dural puncture headache
Time when visual analogue scale score increase and duration until return to 0. Visual analogue scale score for pain assessment. from 0 to ten. 0= no pain 1-3= mild pain....4-6= moderate pain ... 7-10= severe pain
Measured: 5 days post partum
Analgesic request
First time to analgesic request from block
Measured: 24 hours after operation
Analgesc requirements
Total analgesic requirements
Measured: 2 days after operation
frequency of analgesic doses
number of analgesic doses given to the patient
Measured: 5 days
incidence of complications related to the procedure
number of patients with adverse events as bradycardia, tachcardia, miosis,muscle cramps, twitches, colics, hypotension
Measured: 6 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion16 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493838
- Sponsor's protocol ID
- 0379/2023
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06493838
- Acronym / sponsor ID
- 0379/2023
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 16 Jan 2025 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.intravenous 50 mL of sterile saline 0.9% injection of 0.9% after umbilical cord clamping. |
| Neostgmine group | Active comparator | Drug: Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Parturient ladies
- Age ranges from 18 to 35 years old.
- ASA II with elective caesarean section under sub-arachnoid block
Key exclusion criteria (6 listed)
- BMI >35
- Refusal to participate
- surgical complications necessitating a blood transfusion
- Emergency caesarean section
- the need for endotracheal intubation or vasopressors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping. | Drug | Control group |
| Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping. | Drug | Neostgmine group |
Primary outcome
Incidence of patients with post dural puncture headache
Time frame: first 5 days post-partum
Number of patients develop post dural puncture headache
6 secondary outcomes
Severity of post dural puncture headache
Time frame: first 5 days post-partum
onset and duration of post dural puncture headache
Time frame: 5 days post partum
Analgesic request
Time frame: 24 hours after operation
Analgesc requirements
Time frame: 2 days after operation
frequency of analgesic doses
Time frame: 5 days
incidence of complications related to the procedure
Time frame: 6 hours after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping. and Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping. in people with Acute Pain, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients with post dural puncture headache (time frame: first 5 days post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.