Effect of Coffee on Postdural Puncture Headache After Cesarean Section
ConditionPostdural Puncture Headache
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHacettepe University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to read, understand, and communicate in Turkish
Age ≥ 18 years
Undergoing cesarean section under spinal anesthesia
Spinal anesthesia administered in the sitting position
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Coffee Consumption
Dietary supplementThe 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.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Coffee Consumption GroupExperimental treatment 1 intervention
Group B: Standard Care Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
From postoperative hour 6 through postoperative day 5Secondary outcomes
1
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.
Time frame
From postoperative hour 6 through postoperative day 52
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.
Time frame
From postoperative hour 6 through postoperative day 53
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.
Time frame
Once prior to hospital dischargeSponsors and contacts
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Source ClinicalTrials.gov