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

Ataturk University

Status: Enrolling

Conditions: ObsQor-10; Cesarean Section; Preoperative Fasting

Treatments: Other: Carbohydrate Drink; Other: Distilled water group

Study type: Interventional

Funder types: Other

Identifiers

NCT07204795

B.30.2.ATA.0.01.00/331

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Control Group

Sham Comparator group

Description:

Control Group will receive distilled water.

Treatment:

Other: Distilled water group

Intervention Group

Experimental group

Description:

This arm of patients will receive clear carbohydrate drink.

Treatment:

Other: Carbohydrate Drink