Postdural Puncture HeadacheNCT07410741
Effect of Coffee on Postdural Puncture Headache After Cesarean Section
A study testing Coffee Consumption in people with Postdural Puncture Headache, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of postoperative coffee consumption on postdural puncture headache (PDPH) and analgesic use in women undergoing cesarean section with spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- Coffee Consumption
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 15 Jul 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to read, understand, and communicate in Turkish
- Age ≥ 18 years
- Undergoing cesarean section under spinal anesthesia
- Spinal anesthesia administered in the sitting position
- Initiation of oral intake at postoperative hour 6
- No history of physiological discomfort related to coffee consumption based on prior experience (e.g., insomnia, palpitations, headache)
- Ability to understand the study procedures and communicate adequately to provide informed consent
Who cannot join
- Patients undergoing emergency cesarean section
- Patients with a history of migraine or other types of chronic headache disorders
- Patients in whom spinal anesthesia was converted to general anesthesia.
- Patients whose oral intake was postponed for any reason in the postoperative period.
- Patients with high-risk pregnancies.
- Use of caffeine-containing analgesic medications during the postoperative period.
- Postoperative cigarette smoking.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
Official title: The Effect of Postoperative Coffee Consumption on Postdural Puncture Headache and Analgesic Use in Women Undergoing Cesarean Section With Spinal Anesthesia: A Randomized Controlled Trial
The purpose of this study is to investigate the effects of postoperative coffee consumption on postdural puncture headache (PDPH) and analgesic use in women undergoing cesarean section with spinal anesthesia.
Read the detailed description
Surgical procedures are frequently preferred today. The choice of anesthesia is crucial for patient safety in surgical procedures. Spinal anesthesia is recommended in national and international guidelines and protocols. There are many reasons for the frequent preference for spinal anesthesia. Spinal anesthesia provides better pain control than narcotic analgesics in postoperative pain management, reduces systemic opioid use, and allows for earlier onset of bowel movements in the postoperative period. However, postdural puncture headache can also occur with this method.
Postdural puncture headache (PDPH) is one of the most common complications after spinal anesthesia. Current data in the literature indicate a significant incidence of PDPH.
Caffeine has a structure similar to adenosine. Therefore, it replaces adenosine by binding to the same receptors as adenosine. Consequently, caffeine can alleviate headaches through its vasoconstrictive effect. Additionally, caffeine can inhibit the synthesis of leukotrienes and prostaglandins to a limited extent. These properties suggest that caffeine may be effective in pain control. However, the effectiveness of caffeine intake in preventing PDPH has not been definitively established.
The most effective method used to prevent this complication is epidural blood patching. However, this is an invasive procedure. To avoid the drawbacks of invasive methods, reliable, practical, and cost-effective non-invasive methods should be preferred. Caffeine is believed to have a potential role in the prevention of postdural puncture headache based on its mechanism of action.
- Conditions
- Postdural Puncture Headache
- Being tested
- Coffee Consumption
- Keywords
- Post-Dural Puncture Headache, spinal anesthesia, caffeine, cesarean section, coffee
- 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.
Coffee ConsumptionDietary supplement
The first coffee (2 g Nescafe Gold™ in 200 ml of hot water) will be given to the participant within the first hour after starting oral feeding. The second coffee will be scheduled according to the participant's surgery time, individual preferences, and sleep patterns, taking into account the 3-9 hour half-life of caffeine. Participants will be given coffee two more times in the following 24-hour period. Thus, participants will consume coffee four times in 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Coffee Consumption Group | Experimental | Participants assigned to this group will consume coffee in addition to standard post-cesarean care under spinal anesthesia. Receives: Dietary Supplement: Coffee Consumption |
| Standard Care Control Group | No intervention | Participants assigned to this arm will receive standard postoperative care following cesarean section under spinal anesthesia, in accordance with routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postdural Puncture Headache
Incidence of postdural puncture headache will be determined based on the presence or absence of headache at any scheduled assessment during the assessment period, as reported by participants.
Measured: From postoperative hour 6 through postoperative day 5
Secondary outcomes (3)
Severity of Postdural Puncture Headache
The Numeric Rating Scale (NRS) will be used to determine the severity of PDPH. This scale is a one-dimensional tool that allows for the numerical expression of pain intensity on a scale of 0-10. On the scale, 1-3 points are classified as mild pain, 4-6 points as moderate pain, and 7-10 points as severe pain.
Measured: From postoperative hour 6 through postoperative day 5
Postoperative Analgesic Use
Postoperative analgesic use will be assessed by recording the analgesic drug name (commercial and active ingredient), route of administration (oral, intravenous, or intramuscular), date and time of administration, and the amount administered during the assessment period.
Measured: From postoperative hour 6 through postoperative day 5
Patient Satisfaction Level
Patient satisfaction with postoperative, will be assessed using the Numeric Rating Scale - Satisfaction (NRS-S). The scale is a measurement tool where the patient selects a whole number between 0 and 10 to express their satisfaction with the treatment. The scale, divided by 11 lines, indicates 0 for "not satisfied" and 10 for "very satisfied". Those scoring 7 or above on a 10-point scale will be considered satisfied.
Measured: Once prior to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start20 Feb 2026
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, including an intervention group and a standard care control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simay Soyer Içbudak, Hacettepe University
- Investigators
- Zeliha Ozdemir Koken, Study chair, Hacettepe University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410741
- Sponsor's protocol ID
- HU-GSHS-PHD-SN-2026-1
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the sensitive nature of the data collected in this study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative Coffee Consumption on Postdural Puncture Headache and Analgesic Use in Women Undergoing Cesarean Section With Spinal Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07410741
- Acronym / sponsor ID
- HU-GSHS-PHD-SN-2026-1
- Conditions
- Postdural Puncture Headache
- Keywords
- Post-Dural Puncture Headache, spinal anesthesia, caffeine, cesarean section, coffee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 13 Feb 2026 (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 purpose of this study is to investigate the effects of postoperative coffee consumption on postdural puncture headache (PDPH) and analgesic use in women undergoing cesarean section with spinal anesthesia.
Detailed description
Surgical procedures are frequently preferred today. The choice of anesthesia is crucial for patient safety in surgical procedures. Spinal anesthesia is recommended in national and international guidelines and protocols. There are many reasons for the frequent preference for spinal anesthesia. Spinal anesthesia provides better pain control than narcotic analgesics in postoperative pain management, reduces systemic opioid use, and allows for earlier onset of bowel movements in the postoperative period. However, postdural puncture headache can also occur with this method.
Postdural puncture headache (PDPH) is one of the most common complications after spinal anesthesia. Current data in the literature indicate a significant incidence of PDPH.
Caffeine has a structure similar to adenosine. Therefore, it replaces adenosine by binding to the same receptors as adenosine. Consequently, caffeine can alleviate headaches through its vasoconstrictive effect. Additionally, caffeine can inhibit the synthesis of leukotrienes and prostaglandins to a limited extent. These properties suggest that caffeine may be effective in pain control. However, the effectiveness of caffeine intake in preventing PDPH has not been definitively established.
The most effective method used to prevent this complication is epidural blood patching. However, this is an invasive procedure. To avoid the drawbacks of invasive methods, reliable, practical, and cost-effective non-invasive methods should be preferred. Caffeine is believed to have a potential role in the prevention of postdural puncture headache based on its mechanism of action.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups, including an intervention group and a standard care control group.
| Arm | Type | Receives |
|---|---|---|
| Coffee Consumption Group | Experimental | Dietary Supplement: Coffee ConsumptionParticipants assigned to this group will consume coffee in addition to standard post-cesarean care under spinal anesthesia. |
| Standard Care Control Group | No intervention | –Participants assigned to this arm will receive standard postoperative care following cesarean section under spinal anesthesia, in accordance with routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to read, understand, and communicate in Turkish
- Age ≥ 18 years
- Undergoing cesarean section under spinal anesthesia
- Spinal anesthesia administered in the sitting position
- Initiation of oral intake at postoperative hour 6
Key exclusion criteria (7 listed)
- Patients undergoing emergency cesarean section
- Patients with a history of migraine or other types of chronic headache disorders
- Patients in whom spinal anesthesia was converted to general anesthesia.
- Patients whose oral intake was postponed for any reason in the postoperative period.
- Patients with high-risk pregnancies.
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 |
|---|---|---|
| Coffee ConsumptionThe first coffee (2 g Nescafe Gold™ in 200 ml of hot water) will be given to the participant within the first hour after starting oral feeding. The second coffee will be scheduled according to the participant's surgery time, individual preferences, and sleep patterns, taking into account the 3-9 hour half-life of caffeine. Participants will be given coffee two more times in the following 24-hour period. Thus, participants will consume coffee four times in 48 hours. | Dietary supplement | Coffee Consumption Group |
Primary outcome
Incidence of Postdural Puncture Headache
Time frame: From postoperative hour 6 through postoperative day 5
Incidence of postdural puncture headache will be determined based on the presence or absence of headache at any scheduled assessment during the assessment period, as reported by participants.
3 secondary outcomes
Severity of Postdural Puncture Headache
Time frame: From postoperative hour 6 through postoperative day 5
Postoperative Analgesic Use
Time frame: From postoperative hour 6 through postoperative day 5
Patient Satisfaction Level
Time frame: Once prior to hospital discharge
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 23 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the sensitive nature of the data collected in this study.
Related trials for Postdural Puncture Headache
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
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Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
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Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
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Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
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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.
Zeliha Ozdemir Koken study chair
Hacettepe University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee Consumption in people with Postdural Puncture Headache, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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 23 Jul 2026. 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 Turkey (Türkiye). 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?
Incidence of Postdural Puncture Headache (time frame: From postoperative hour 6 through postoperative day 5). 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 23 Jul 2026.