AnalgesiaNCT04662125
Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin
A study testing caffeine, paracetamol tablet, Oral prednisolone and oral pregabalin in people with Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- caffeine, paracetamol tablet, Oral prednisolone and oral pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2020to 30 Aug 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Both gender.
- Age: 18- 65 years old.
- Body Mass Index 20-30 kg/m2
- American Society of Anesthesiologist (ASA) physical status I - II.
- Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries .
Who cannot join
- - Allergy to study drugs.
- History of chronic headache and migraine.
- History of cerebrovascular accidents and neurological disorders.
- Systemic infection
- History of uncontrolled DM or hepatic disease or pregnant female
- Patient refusal or uncooperative patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries
The aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery.
Read the detailed description
- To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries.
- To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups.
- To detect any side effects of the study medications in all patient groups.
- Conditions
- Analgesia
- Being tested
- caffeine, paracetamol tablet, Oral prednisolone, oral pregabalin
- Keywords
- oral prednisolone, oral pregabalin, post dural puncture headache (PDPH), lower limb surgeries
- Medical subject headings
- Agnosia, Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine, paracetamol tabletDrug
oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days.
Oral prednisoloneDrug
patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. .
oral pregabalinDrug
patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Group A (conservative treatment): oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days. Receives: Drug: caffeine, paracetamol tablet |
| group B | Active comparator | Group B (oral prednisolone): patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. Receives: Drug: Oral prednisolone |
| group C | Active comparator | Group C (oral pregabalin): patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days. Receives: Drug: oral pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity of headache
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
Measured: From onset of the headache (0 hour).
pain intensity of headache
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
Measured: at 12 hours
pain intensity of headache
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
Measured: at 24 hours
pain intensity of headache
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
Measured: at 48 hours
pain intensity of headache
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
Measured: at 72 hours
Headache intensity
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Measured: From onset of the headache (0 hour).
Headache intensity
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Measured: at 12 hours
Headache intensity
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Measured: at 24 hours
Headache intensity
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Measured: at 48 hours
Headache intensity
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Measured: at 72 hours
Secondary outcomes (3)
Associated symptoms of post dural puncture headache
The number of participant who has symptoms of post dural pucture headache as nausea, vomiting, diplopia, dizziness and neck stiffness
Measured: for 72 hours
Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness
In case of sedation, the level will be assessed by using Ramsay Sedation Score (1= anxious or agitated, 2= cooperative and oriented, 3= responds to commands only and 4= brisk response to light tap or loud auditory stimulus)
Measured: for 72 hours
total dose of rescue analgesia
total amount of ketorolac
Measured: for 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start10 Dec 2020
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Analgesic management of post dural puncture headache: oral prednisolone vs oral pregabalin
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
- Investigators
- Dina Salem, MD, Principal investigator, faculty of medicine , Zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662125
- Sponsor's protocol ID
- 6324
- Status last verified
- Oct 2023
- First submitted
- 28 Nov 2020
- Last updated
- 1 Nov 2023
- 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries
- ClinicalTrials.gov ID
- NCT04662125
- Acronym / sponsor ID
- 6324
- Conditions
- Analgesia
- Keywords
- oral prednisolone, oral pregabalin, post dural puncture headache (PDPH), lower limb surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 10 Dec 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 aim of this study is to compare between oral prednisolone and oral pregabalin in management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH, total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in patients undergoing lower limb surgery.
Detailed description
- To compare between oral prednisolone and oral pregabalin in reducing severity post-dural puncture headache after spinal anesthesia in patients undergoing lower limb surgeries.
- To calculate total amount of postoperative analgesic requirement for 72 hours after the onset of the headache in all patient groups.
- To detect any side effects of the study medications in all patient groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Analgesic management of post dural puncture headache: oral prednisolone vs oral pregabalin
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: caffeine, paracetamol tabletGroup A (conservative treatment): oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days. |
| group B | Active comparator | Drug: Oral prednisoloneGroup B (oral prednisolone): patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. |
| group C | Active comparator | Drug: oral pregabalinGroup C (oral pregabalin): patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Both gender.
- Age: 18- 65 years old.
- Body Mass Index 20-30 kg/m2
- American Society of Anesthesiologist (ASA) physical status I - II.
- Patients are diagnosed as PDPH according to criteria of International Headache Society (IHS) after lower limb surgeries .
Key exclusion criteria (6 listed)
- - Allergy to study drugs.
- History of chronic headache and migraine.
- History of cerebrovascular accidents and neurological disorders.
- Systemic infection
- History of uncontrolled DM or hepatic disease or pregnant female
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 |
|---|---|---|
| caffeine, paracetamol tabletoral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days. | Drug | group A |
| Oral prednisolonepatients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. . | Drug | group B |
| oral pregabalinpatients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days. | Drug | group C |
Primary outcome
pain intensity of headache
Time frame: From onset of the headache (0 hour).
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
pain intensity of headache
Time frame: at 12 hours
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
pain intensity of headache
Time frame: at 24 hours
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
pain intensity of headache
Time frame: at 48 hours
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
pain intensity of headache
Time frame: at 72 hours
measured by Visual Analogue Scale (VAS) on 0-10 cm scale (0-1 no headache, 2-4 mild headache, 5-7 moderate headache and 8-10 sever headache)
Headache intensity
Time frame: From onset of the headache (0 hour).
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Headache intensity
Time frame: at 12 hours
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Headache intensity
Time frame: at 24 hours
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Headache intensity
Time frame: at 48 hours
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
Headache intensity
Time frame: at 72 hours
modified Lybecker score :1: include patients with mild headache not affecting daily activity with no accompanying symptoms, and oral analgesics work effectively to relieve pain, grade 2: moderate headache that restricts daily activity and leaves the patient in bed for most of the day, injectable analgesia is required to relieve pain, and grade 3: Severe headache with associated symptoms, completely restrict daily activity, with patients kept bed bound for the whole day.
3 secondary outcomes
Associated symptoms of post dural puncture headache
Time frame: for 72 hours
Adverse effects of the study drugs e.g. sedation, blurred vision, sleepiness, and dizziness
Time frame: for 72 hours
total dose of rescue analgesia
Time frame: for 72 hours
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 1 Nov 2023.
- 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.
Dina Salem, MD principal investigator
faculty of medicine , Zagazig university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine, paracetamol tablet, Oral prednisolone and oral pregabalin in people with Analgesia, run by Zagazig 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 5 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: finished, as of the sponsor's last update on 1 Nov 2023. 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. 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?
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?
pain intensity of headache (time frame: From onset of the headache (0 hour).). The study lists 10 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 1 Nov 2023.