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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07204795
Enrollment
100
Registered
2025-10-02
Start date
2025-05-20
Completion date
2026-05-31
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ObsQor-10, Cesarean Section, Preoperative Fasting

Keywords

ObsQor-10, Cesarean Section, Neuraxial Anesthesia, Preoperative Fasting, Oral Clear Carbohydrate Drink

Brief summary

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

Detailed description

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.

Interventions

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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ObsQor-10 ScoresFrom enrollment to 48th hour postoperativelyPrimary outcome assessment will be based on the ObsQoR-10 (Obstetric Quality of Recovery-10) scores at 24 and 48 hours postoperatively.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAyşenur Dostbil, Proffessor
adostbil@hotmail.com+905333676696

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026