- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410741
Effect of Coffee on Postdural Puncture Headache After Cesarean Section
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Simay Soyer Icbudak, PhD Candidate
- Phone Number: +90 5326029045
- Email: simay.soyer@hacettepe.edu.tr
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06800
- Recruiting
- Ankara Bilkent City Hospital
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Contact:
- Simay Soyer Icbudak
- Phone Number: +905326029045
- Email: simay.soyer@hacettepe.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coffee Consumption Group
Participants assigned to this group will consume coffee in addition to standard post-cesarean care under spinal anesthesia.
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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.
|
|
No Intervention: Standard Care Control Group
Participants assigned to this arm will receive standard postoperative care following cesarean section under spinal anesthesia, in accordance with routine clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Postdural Puncture Headache
Time Frame: From postoperative hour 6 through postoperative day 5
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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.
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From postoperative hour 6 through postoperative day 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Postdural Puncture Headache
Time Frame: From postoperative hour 6 through postoperative day 5
|
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.
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From postoperative hour 6 through postoperative day 5
|
|
Postoperative Analgesic Use
Time Frame: From postoperative hour 6 through postoperative day 5
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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.
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From postoperative hour 6 through postoperative day 5
|
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Patient Satisfaction Level
Time Frame: Once prior to hospital discharge
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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.
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Once prior to hospital discharge
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Zeliha Ozdemir Koken, Hacettepe University Faculty of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-GSHS-PHD-SN-2026-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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