Post-Dural Puncture HeadachePhase 4PDPHNCT03910088
Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean
A Phase 4 study testing Pregabalin 100Mg Oral Cap, Hydrocortisone and Acetaminophen in people with Post-Dural Puncture Headache, run by Cairo University at 1 site in Egypt.
Trial summary
Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Pregabalin 100Mg Oral Cap, Hydrocortisone and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2019to 30 Jun 2019
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who underwent elective cesarean section under spinal anesthesia.
- Patients aged 18 to 40 years old.
- Patients classified as ASA I or II.
Who cannot join
- Patients with known sensitivity to any of the used drugs.
- Patients classified as ASA III or more.
- Preeclampsia.
- Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section
Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.
Read the detailed description
The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Pregabalin 100Mg Oral Cap, Hydrocortisone, Acetaminophen, oral fluids, Caffeine
- Keywords
- spinal, cesarean, pregabalin
- 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.
Pregabalin 100Mg Oral CapDrug
giving a drug to relieve post-dural puncture headache
HydrocortisoneDrug
Giving drug to relieve post-dural puncture headache
AcetaminophenDrug
Also called Paracetamol
giving a drug to relieve post-dural puncture headache
oral fluidsOther
Also called good hydration
giving oral fluids to maintain good hydration
CaffeineDrug
giving a drug to relieve post-dural puncture headache
DiclofenacDrug
giving a drug to relieve post-dural puncture headache
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | received conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours Receives: Drug: Acetaminophen; Other: oral fluids; Drug: Caffeine; Drug: Diclofenac |
| Pregabalin | Active comparator | received the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours Receives: Drug: Pregabalin 100Mg Oral Cap; Drug: Acetaminophen; Other: oral fluids; Drug: Caffeine; Drug: Diclofenac |
| Hydrocortisone | Active comparator | received the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. Receives: Drug: Hydrocortisone; Drug: Acetaminophen; Other: oral fluids; Drug: Caffeine; Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain using Visual Analogue Scale
Headache intensity after 1 minute in upright position using the Visual Analogue Scale for pain assessment ranging from 0 to 10, with zero means no pain and 10 is the worst pain after 48 hours of treatment
Measured: the first 48 hours following treatment
Secondary outcomes (3)
Assessment of the amount of rescue drug
Total dose of nalbuphine given in each group..
Measured: The first 48 hours following treatment
incidence of side effects of the studied drug
incidence of Somnolence
Measured: the first 48 hours following treatment
incidence of side effect of the studied drug
incidence of dizziness
Measured: the first 48 hours following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start20 Apr 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrine El-Refai, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910088
- Sponsor's protocol ID
- CairoU11112017
- Acronym
- PDPH
- Status last verified
- Nov 2019
- First submitted
- 2 Apr 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03910088
- Acronym / sponsor ID
- PDPH / CairoU11112017
- Conditions
- Post-Dural Puncture Headache
- Keywords
- spinal, cesarean, pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 Apr 2019 (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.
Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal anesthesia for elective cesarean section.
Detailed description
The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for elective cesarean section. Patients will be divided into three groups: Control group (group C):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three groups will be compared regarding the headache intensity using a visual analog scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Acetaminophen, Other: oral fluids, Drug: Caffeine, Drug: Diclofenacreceived conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours |
| Pregabalin | Active comparator | Drug: Pregabalin 100Mg Oral Cap, Drug: Acetaminophen, Other: oral fluids, Drug: Caffeine, Drug: Diclofenacreceived the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours |
| Hydrocortisone | Active comparator | Drug: Hydrocortisone, Drug: Acetaminophen, Other: oral fluids, Drug: Caffeine, Drug: Diclofenacreceived the conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who underwent elective cesarean section under spinal anesthesia.
- Patients aged 18 to 40 years old.
- Patients classified as ASA I or II.
Key exclusion criteria (4 listed)
- Patients with known sensitivity to any of the used drugs.
- Patients classified as ASA III or more.
- Preeclampsia.
- Patients with a history of chronic headache or migraine Patients receiving pregabalin for chronic pain.
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 |
|---|---|---|
| Pregabalin 100Mg Oral Capgiving a drug to relieve post-dural puncture headache | Drug | Pregabalin |
| HydrocortisoneGiving drug to relieve post-dural puncture headache | Drug | Hydrocortisone |
| AcetaminophenAlso: Paracetamolgiving a drug to relieve post-dural puncture headache | Drug | Hydrocortisone, Pregabalin, control group |
| oral fluidsAlso: good hydrationgiving oral fluids to maintain good hydration | Other | Hydrocortisone, Pregabalin, control group |
| Caffeinegiving a drug to relieve post-dural puncture headache | Drug | Hydrocortisone, Pregabalin, control group |
| Diclofenacgiving a drug to relieve post-dural puncture headache | Drug | Hydrocortisone, Pregabalin, control group |
Primary outcome
Assessment of pain using Visual Analogue Scale
Time frame: the first 48 hours following treatment
Headache intensity after 1 minute in upright position using the Visual Analogue Scale for pain assessment ranging from 0 to 10, with zero means no pain and 10 is the worst pain after 48 hours of treatment
3 secondary outcomes
Assessment of the amount of rescue drug
Time frame: The first 48 hours following treatment
incidence of side effects of the studied drug
Time frame: the first 48 hours following treatment
incidence of side effect of the studied drug
Time frame: the first 48 hours following treatment
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 12 Nov 2019.
- Individual participant dataSharing planned: No
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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 Pregabalin 100Mg Oral Cap, Hydrocortisone and Acetaminophen in people with Post-Dural Puncture Headache, run by Cairo University at 1 site in Egypt.
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 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 12 Nov 2019. 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 Egypt. 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?
Assessment of pain using Visual Analogue Scale (time frame: the first 48 hours following treatment). 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 12 Nov 2019.