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Completed

NCT Number: NCT07410741

Effect of Coffee on Postdural Puncture Headache After Cesarean Section

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coffee Consumption

Dietary 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Postoperative Analgesic Use

    Time frame: From postoperative hour 6 through postoperative day 5

    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.

  3. Patient Satisfaction Level

    Time frame: Once prior to hospital discharge

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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