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NCT Number: NCT07204795

Effect of Preoperative Oral Carbohydrate Drink on ObsQoR-10 Score After Elective Cesarean Under Neuraxial Anesthesia

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Research Hospital

Erzurum, 25700, Turkey (Türkiye)

Location status: Recruiting

Location contact

Miraç Selcen Özkal Yalın, Doctor

CONTACT

[email protected]

905393849811

About this study

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.

Who can participate

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

Treatment and study plan

Distilled water group

Other

Group A participants will receive 400 mL of distilled water orally, two hours before surgery.

Carbohydrate Drink

Other

Group A participants will receive 400 mL of a commercially available clear carbohydrate-rich drink orally, two hours before surgery.

Primary outcomes

  1. ObsQor-10 Scores

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşenur Dostbil, Proffessor

CONTACT

[email protected]

+905333676696

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

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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