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临床试验/NCT07410741
NCT07410741已完成不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2026年2月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Incidence of Postdural Puncture Headache

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

Coffee Consumption Group

Experimental

Participants assigned to this group will consume coffee in addition to standard post-cesarean care under spinal anesthesia.

干预措施: Coffee Consumption (Dietary Supplement)

结局指标

主要结局

Incidence of Postdural Puncture Headache

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simay Soyer Içbudak

Principal Investigator

Hacettepe University

研究点 (1)

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