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
1 other identifier
interventional
82
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedStudy Start
First participant enrolled
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 2, 2026
February 1, 2026
9 months
February 7, 2026
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From postoperative hour 6 through postoperative day 5
Secondary Outcomes (3)
Severity of Postdural Puncture Headache
From postoperative hour 6 through postoperative day 5
Postoperative Analgesic Use
From postoperative hour 6 through postoperative day 5
Patient Satisfaction Level
Once prior to hospital discharge
Study Arms (2)
Coffee Consumption Group
EXPERIMENTALParticipants assigned to this group will consume coffee in addition to standard post-cesarean care under spinal anesthesia.
Standard Care Control Group
NO INTERVENTIONParticipants assigned to this arm will receive standard postoperative care following cesarean section under spinal anesthesia, in accordance with routine clinical practice.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Bilkent City Hospital
Ankara, Ankara, 06800, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zeliha Ozdemir Koken
Hacettepe University Faculty of Nursing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and investigators will not be blinded. Outcome assessment will be performed by an independent statistician who will be blinded to group allocation through coded group assignments (e.g., Group A and Group B).
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 7, 2026
First Posted
February 13, 2026
Study Start
February 20, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared due to the sensitive nature of the data collected in this study.