Evaluation of the Effect of Preoperatively Administered Oral Clear Carbohydrate-Rich Drink on ObsQoR-10 Recovery Scores of Patients Undergoing Elective Cesarean Section With Neuraxial Anesthesia: A Prospective, Randomized, Controlled, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ObsQor-10 Scores
研究概览
简要总结
The goal of this clinical trial is to determine whether a preoperative oral carbohydrate-rich clear drink can improve recovery in women undergoing elective cesarean section under neuraxial anesthesia. The main outcomes it aims to answer are:
Primary Outcome: Does the carbohydrate drink improve ObsQoR-10 scores at 24 and 48 hours postoperatively?
Secondary Outcomes: Does it reduce patients' hunger, thirst, and anxiety levels?
Researchers will compare patients receiving a 400 ml oral carbohydrate-rich clear drink 2 hours before surgery (Group A) to those receiving 400 ml distilled water (Group B), to assess differences in recovery and comfort.
Participants will:
Be randomized into two equal groups (n=50 each) using a computer-generated randomization table
Receive standardized anesthesia and postoperative analgesia
详细描述
This prospective, randomized, controlled, double-blind clinical trial will be conducted at Atatürk University Faculty of Medicine Hospital, following approval from the institutional ethics committee and after obtaining written informed consent from all participants. The study population will consist of 100 pregnant women scheduled for elective cesarean section under neuraxial anesthesia.Randomization will be performed using a computer-generated random numbers table by an independent statistician, allocating patients equally into two groups (Group A and Group B). Randomization will be performed using a computer-generated random numbers table by an independent statistician, allocating patients equally into two groups (Group A and Group B).
Upon arrival in the operating room, patients will undergo routine monitoring. Cesarean delivery will be performed using either spinal anesthesia or combined spinal-epidural anesthesia based on clinical indications. Intrathecal anesthesia will consist of 11.2 mg hyperbaric bupivacaine, 15 µg fentanyl, and 150 µg morphine. If additional analgesia is required through the epidural route, a mixture of 15 mL 2% lidocaine, 2 mL fentanyl, 2 mL sodium bicarbonate, and 1:200,000 adrenaline will be administered.
For intraoperative analgesia, all patients will receive 1 g intravenous acetaminophen, and, if not contraindicated, 800 mg intravenous ibuprofen. Postoperative pain management will include scheduled doses of 1 g acetaminophen and 800 mg ibuprofen every 8 hours for 48 hours. If the visual analog pain score (VAS) exceeds 3, 5 mg of oral oxycodone will be given as rescue analgesia. At discharge, patients will be prescribed up to 20 tablets of 5 mg oxycodone for breakthrough pain, with advice to continue regular acetaminophen and ibuprofen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Scheduled for elective cesarean section under neuraxial anesthesia
- •Gestational age ≥37 weeks
排除标准
- •Contraindication to neuraxial anesthesia
- •Age <18 years
- •Refusal to participate in the study
- •Hiatal hernia
- •Intestinal obstruction
- •Gastroesophageal reflux disease (GERD)
- •Diabetes mellitus
- •Fetal anomalies
- •Eclampsia or preeclampsia
- •Substance abuse
- •Chronic pain conditions
研究组 & 干预措施
Control Group
Control Group will receive distilled water.
干预措施: Distilled water group (Other)
Intervention Group
This arm of patients will receive clear carbohydrate drink.
干预措施: Carbohydrate Drink (Other)
结局指标
主要结局
ObsQor-10 Scores
时间窗: From enrollment to 48th hour postoperatively
Primary outcome assessment will be based on the ObsQoR-10 (Obstetric Quality of Recovery-10) scores at 24 and 48 hours postoperatively.
次要结局
未报告次要终点
研究者
Aysenur Dostbil
Professor Dr.
Ataturk University