Ataturk University Research Hospital
Erzurum, 25700, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07204795
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
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Erzurum, 25700, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age ≥18 years
Scheduled for elective cesarean section under neuraxial anesthesia
Gestational age ≥37 weeks
Exclusion criteria
Contraindication to neuraxial anesthesia
Age <18 years
Refusal to participate in the study
Obesity
Hiatal hernia
Intestinal obstruction
Gastroesophageal reflux disease (GERD)
Diabetes mellitus
Fetal anomalies
Eclampsia or preeclampsia
Substance abuse
Chronic pain conditions
Group A participants will receive 400 mL of distilled water orally, two hours before surgery.
Group A participants will receive 400 mL of a commercially available clear carbohydrate-rich drink orally, two hours before surgery.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ataturk University
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT05879536
Cesarean Section, Neurologic Manifestations
Valencia, Spain
View Trial DetailsNCT06282952
Body Weight, Cesarean Section
Oulu, Finland
View Trial DetailsNCT07686913
Cesarean Section, Infections
Moreno Valley, California, United States
View Trial DetailsNCT07511491
Cesarean Section, Intravenous
Tanta, El-Gharbia, Egypt
View Trial Details