Post-Dural Puncture HeadacheOPDPHNCT06444737
Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia
A study testing Intravenous ondansetron and Intravenous normal saline in people with Post-Dural Puncture Headache, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups: Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Intravenous ondansetron and Intravenous normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- 30 Nov 2023to 30 Aug 2024
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18-45 years
- ASA 2
- Between 37 and 41 weeks of gestation
- scheduled for elective caesarean delivery under spinal anaesthesia
- To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification
Who cannot join
- All patients who required :
- more than two attempts for spinal anaesthesia
- conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level <T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).
- As well as patients who have subsequently withdrawn their consent for participating to our study.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Mongi slim hospital
Tunis, 2085
Mhamed sami Mebazaa, professor, 22252589 ext. 00216, msmebazaa@gmail.com
Amani Ben haj Youssef, assistant, 96874336 ext. 00216, amanibhy@hotmail.fr
About this study
Official title: Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial
A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups:
Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
Read the detailed description
Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications.
Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%.
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024.
the investigators included in the study all parturients:
- Aged between 18-45 years
- ASA 2
- Between 37 and 41 weeks of gestation
- scheduled for elective caesarean delivery under spinal anaesthesia
- To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification.
The eligible parturients were randomly assigned to two groups through block randomization using computerized random numbers.
were assigned to one of the two parallel groups to receive either :
- Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia : Group O (Ondansetron)
- Or IV normal saline 5 ml (control group) 5 min before spinal anesthesia : Group C (control)
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Intravenous ondansetron, Intravenous normal saline
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ondansetronDrug
Also called ondansetron
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Intravenous normal salineDrug
Also called Placebo
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group O | Experimental | Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Receives: Drug: Intravenous ondansetron |
| Group C | Placebo comparator | Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia Receives: Drug: Intravenous normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.
the occurrence of positional headaches at any time postoperatively
Measured: 7 days
Secondary outcomes (7)
day of PDPH's occurence
on postoperatively
Measured: 7 days
day of PDPH's resolution
on postoperatively
Measured: 7 days
Headache severity
assessed by the numerical pain scale from 0 to 10 (0 being no pain and 10 being the maximum unimaginable pain).
Measured: 7 days
Need for analgesic treatment due to headaches
paracetamol or NSAIDs
Measured: 7 days
Occurrence of post-operative nausea and/or vomiting
need of treatement
Measured: 7 days
Mean arterial pressure in mmgh
Mean arterial pressure during hospitalization
Measured: 3 days
heart rate
Mean arterial pressure during hospitalization
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start30 Nov 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444737
- Sponsor's protocol ID
- ondansetron effect on PDPH
- Acronym
- OPDPH
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06444737
- Acronym / sponsor ID
- OPDPH / ondansetron effect on PDPH
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 6 Jun 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.
A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups:
Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
Detailed description
Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications.
Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%.
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024.
the investigators included in the study all parturients:
- Aged between 18-45 years
- ASA 2
- Between 37 and 41 weeks of gestation
- scheduled for elective caesarean delivery under spinal anaesthesia
- To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification.
The eligible parturients were randomly assigned to two groups through block randomization using computerized random numbers.
were assigned to one of the two parallel groups to receive either :
- Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia : Group O (Ondansetron)
- Or IV normal saline 5 ml (control group) 5 min before spinal anesthesia : Group C (control)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group O | Experimental | Drug: Intravenous ondansetronGroup ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia |
| Group C | Placebo comparator | Drug: Intravenous normal salineGroup control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18-45 years
- ASA 2
- Between 37 and 41 weeks of gestation
- scheduled for elective caesarean delivery under spinal anaesthesia
- To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification
Key exclusion criteria (4 listed)
- All patients who required :
- more than two attempts for spinal anaesthesia
- conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level <T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).
- As well as patients who have subsequently withdrawn their consent for participating to our study.
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 ondansetronAlso: ondansetronIntravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia | Drug | Group O |
| Intravenous normal salineAlso: PlaceboIntravenous normal saline 5 ml (control group) 5 min before spinal anesthesia | Drug | Group C |
Primary outcome
Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.
Time frame: 7 days
the occurrence of positional headaches at any time postoperatively
7 secondary outcomes
day of PDPH's occurence
Time frame: 7 days
day of PDPH's resolution
Time frame: 7 days
Headache severity
Time frame: 7 days
Need for analgesic treatment due to headaches
Time frame: 7 days
Occurrence of post-operative nausea and/or vomiting
Time frame: 7 days
Mean arterial pressure in mmgh
Time frame: 3 days
heart rate
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous ondansetron and Intravenous normal saline in people with Post-Dural Puncture Headache, run by Mongi Slim Hospital at 1 site in Tunisia.
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 5 inclusion and 4 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Mhamed Sami Mebazaa, professor (22252589 ext. 00216, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-dural punction headache (PDPH) during the first seven postoperative days. (time frame: 7 days). 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 6 Jun 2024.