PDPHPhase 4PDPHNCT04393766
Prophylactic Intrathecal Normal Saline for Prevention of Post Dural Puncture Headache in Women Undergoing Cesarean Section Under Spinal Anesthesia
A Phase 4 study testing Normal Saline in people with PDPH, run by Dilla University at 1 site in Ethiopia.
Trial summary
The rates of cesarean section are increasing worldwide despite ten to fifteen percent of World Health Organization recommendation and from which 80-90% of cesarean sections are performed with spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PDPH
- What is being tested?
- Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteEthiopia
- Study dates
- 23 Feb 2020to 30 Sep 2021
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- American society of anesthesiologists' physical status classification(ASA I and II)
- Term pregnant lady
Who cannot join
- patient whose ASA status was greater than three
- previous history of PDPH
- previous history of migraine headache
- BMI greater than 25 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Prophylactic Intrathecal Normal Saline for Prevention of Post Dural Puncture Headache in Women Undergoing Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial
The rates of cesarean section are increasing worldwide despite ten to fifteen percent of World Health Organization recommendation and from which 80-90% of cesarean sections are performed with spinal anesthesia. Post Dural Puncture Headache is the commonest complications associated with spinal anesthesia with prevalence as high as forty percent in Ethiopia. Body of evidence revealed that Conservative managements failed to show significant benefit and epidural needle and catheter techniques didn't provide conclusive evidences. On the other hand, intrathecal injection of normal saline is very safe, simple technique and cost effective in resource limited set up but it is not well examined on its efficacy and safety profiles. The main objective of the study is to assess of efficacy and safety of prophylactic Intrathecal Normal Saline for prevention of Post Dural Puncture Headache in women undergoing cesarean section under spinal anesthesia. After Obtaining Ethical clearance from IRB, a Randomized Controlled Trial study will be conducted in Dilla University Referral Hospital from december2019 to December, 2020. 152 mothers scheduled caesarean section under spinal anesthesia fulfilling the inclusion criteria will be allocated into two groups randomly with random sequence generated list obtained from R package (Random Allocation Rule function) software version 3.6.
Read the detailed description
The rates of cesarean section are increasing worldwide despite ten to fifteen percent of World Health Organization recommendation and from which 80-90% of cesarean sections are performed with spinal anesthesia. Post Dural Puncture Headache is the commonest complications associated with spinal anesthesia with prevalence as high as forty percent in Ethiopia. Body of evidence revealed that Conservative managements failed to show significant benefit and epidural needle and catheter techniques didn't provide conclusive evidences. On the other hand, intrathecal injection of normal saline is very safe, simple technique and cost effective in resource limited set up but it is not well examined on its efficacy and safety profiles. The main objective of the study is to assess of efficacy and safety of prophylactic Intrathecal Normal Saline for prevention of Post Dural Puncture Headache in women undergoing cesarean section under spinal anesthesia.
After Obtaining Ethical clearance from IRB, a Randomized Controlled Trial study will be conducted in Dilla University Referral Hospital from October 2019 to May, 2020. 152 mothers scheduled caesarean section under spinal anesthesia fulfilling the inclusion criteria will be allocated into two groups randomly with random sequence generated list obtained from R package (Random Allocation Rule function) software version 3.6. Data will be entered, cleaned by Epi-info version 7 and imported to Statistical Package for Social Sciences version 22 for analysis. Descriptive statistics will be run to see the overall distribution of the study subjects with regard to the variables under study. Unpaired student's T-test for continuous symmetric data and Mann Whitney U test for non-normally distributed data will be used to see the mean difference between the groups. Categorical data will be analyzed with Chi square and fisher's exact test where appropriate. Survival analysis will be done to estimate the probability having PDPH within five days postoperatively.
- Conditions
- PDPH
- Being tested
- Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
normal saline(crystalloids)
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Experimental | Not described Receives: Drug: Normal Saline |
| non normal saline | Placebo comparator | Not described Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of PDPH
occurance of post dural puncture headache
Measured: for five days postoperatively( 12hrs -5 days)
severity of PDPH
severity of PDPH will be assessed with validated scale( visual analog score)
Measured: 12hrs to 5 days postoperatively
Secondary outcomes (2)
peak sensory block
sensory block
Measured: 30 minutes after injection of spinal anesthetics
motor block
motor block with bromage score
Measured: 30 minutes after spinal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start23 Feb 2020
- Primary completion23 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDPHStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semagn Mekonnen, Dilla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393766
- Sponsor's protocol ID
- 0014/19-11
- Acronym
- PDPH
- Status last verified
- Mar 2022
- First submitted
- 14 May 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prophylactic Intrathecal Normal Saline for Prevention of Post Dural Puncture Headache in Women Undergoing Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04393766
- Acronym / sponsor ID
- PDPH / 0014/19-11
- Conditions
- PDPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Dilla UniversityUniversity, hospital or other
- Study start
- 23 Feb 2020 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 May 2020 (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.
The rates of cesarean section are increasing worldwide despite ten to fifteen percent of World Health Organization recommendation and from which 80-90% of cesarean sections are performed with spinal anesthesia. Post Dural Puncture Headache is the commonest complications associated with spinal anesthesia with prevalence as high as forty percent in Ethiopia. Body of evidence revealed that Conservative managements failed to show significant benefit and epidural needle and catheter techniques didn't provide conclusive evidences. On the other hand, intrathecal injection of normal saline is very safe, simple technique and cost effective in resource limited set up but it is not well examined on its efficacy and safety profiles. The main objective of the study is to assess of efficacy and safety of prophylactic Intrathecal Normal Saline for prevention of Post Dural Puncture Headache in women undergoing cesarean section under spinal anesthesia. After Obtaining Ethical clearance from IRB, a Randomized Controlled Trial study will be conducted in Dilla University Referral Hospital from december2019 to December, 2020. 152 mothers scheduled caesarean section under spinal anesthesia fulfilling the inclusion criteria will be allocated into two groups randomly with random sequence generated list obtained from R package (Random Allocation Rule function) software version 3.6.
Detailed description
The rates of cesarean section are increasing worldwide despite ten to fifteen percent of World Health Organization recommendation and from which 80-90% of cesarean sections are performed with spinal anesthesia. Post Dural Puncture Headache is the commonest complications associated with spinal anesthesia with prevalence as high as forty percent in Ethiopia. Body of evidence revealed that Conservative managements failed to show significant benefit and epidural needle and catheter techniques didn't provide conclusive evidences. On the other hand, intrathecal injection of normal saline is very safe, simple technique and cost effective in resource limited set up but it is not well examined on its efficacy and safety profiles. The main objective of the study is to assess of efficacy and safety of prophylactic Intrathecal Normal Saline for prevention of Post Dural Puncture Headache in women undergoing cesarean section under spinal anesthesia.
After Obtaining Ethical clearance from IRB, a Randomized Controlled Trial study will be conducted in Dilla University Referral Hospital from October 2019 to May, 2020. 152 mothers scheduled caesarean section under spinal anesthesia fulfilling the inclusion criteria will be allocated into two groups randomly with random sequence generated list obtained from R package (Random Allocation Rule function) software version 3.6. Data will be entered, cleaned by Epi-info version 7 and imported to Statistical Package for Social Sciences version 22 for analysis. Descriptive statistics will be run to see the overall distribution of the study subjects with regard to the variables under study. Unpaired student's T-test for continuous symmetric data and Mann Whitney U test for non-normally distributed data will be used to see the mean difference between the groups. Categorical data will be analyzed with Chi square and fisher's exact test where appropriate. Survival analysis will be done to estimate the probability having PDPH within five days postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline | Experimental | Drug: Normal Saline |
| non normal saline | Placebo comparator | Drug: Normal Saline |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American society of anesthesiologists' physical status classification(ASA I and II)
- Term pregnant lady
Key exclusion criteria (4 listed)
- patient whose ASA status was greater than three
- previous history of PDPH
- previous history of migraine headache
- BMI greater than 25 kg/m2
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 |
|---|---|---|
| Normal Salinenormal saline(crystalloids) | Drug | non normal saline, normal saline |
Primary outcome
incidence of PDPH
Time frame: for five days postoperatively( 12hrs -5 days)
occurance of post dural puncture headache
severity of PDPH
Time frame: 12hrs to 5 days postoperatively
severity of PDPH will be assessed with validated scale( visual analog score)
2 secondary outcomes
peak sensory block
Time frame: 30 minutes after injection of spinal anesthetics
motor block
Time frame: 30 minutes after spinal injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for PDPH
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal Saline in people with PDPH, run by Dilla University at 1 site in Ethiopia.
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 2 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: finished, as of the sponsor's last update on 22 Mar 2022. 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 Ethiopia. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 PDPH (time frame: for five days postoperatively( 12hrs -5 days)). The study lists 2 primary outcomes in all. 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 22 Mar 2022.