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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery

NCT05841693

Quality of Life Breastfeeding Postoperative Pain +1 more

COMPLETED PHASE4

Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis

NCT05494268

COMPLETED

Preoperative Carbohydrate Drink Prior to Elective Caesarean Section

NCT04159948

Fasting Cesarean Delivery Affecting Fetus Glucose, Low Blood

UNKNOWN NA

Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

NCT03732404

Cesarean Section Complications

COMPLETED NA

Gastric Voume Assessment for Aspiration Risk in OB ERAS Patients

NCT03842527

Cesarean Section

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ObsQor-10 Cesarean Section Preoperative Fasting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Control Group will receive distilled water.

Group Type SHAM_COMPARATOR

Distilled water group

Intervention Type OTHER

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

Intervention Group

This arm of patients will receive clear carbohydrate drink.

Group Type EXPERIMENTAL

Carbohydrate Drink

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Distilled water group

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

Intervention Type OTHER

Carbohydrate Drink

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes