Quality of Recovery in Parturients Consumed Preoperative Carbohydrate Fluid for Elective Cesarean Delivery (QoR-10)

Karamanoğlu Mehmetbey University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Quality of Life; Breastfeeding; Postoperative Nausea

Treatments: Drug: Placebo; Drug: Carbohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05841693

1111

Details and patient eligibility

About

The establishment of the Enhanced Recovery After Cesarean protocols resulted in to the production of specific care pathways with the aim of optimizing recovery after cesarean delivery (CD) and to reduce the costs to the health care system. Carbohydrate rich fluids are offered in this aspect to enhance postoperative quality of recovery. The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on obstetric quality of recovery after elective cesarean section.

Full description

The 10-item Obstetric Quality-of-Recovery scale is a validated patient-reported outcome questionnaire that evaluates recovery quality after delivery. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. The shortened pre-operative fasting period, in addition to the positive metabolic effects, enhance the post-operative recovery and shorten the hospital stay. Postoperatively, it is also crucial for the mother to heal rapidly and be able to care for her child on her own. Although a lot of effects of the preoperative carbohydrate loading has been studied yet, the OQR-10 scale and after carbohydrate loading has not been investigated yet.

All mothers undergoing a planned CD in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive carbohydrate solution ( Carb Group) and the other will consume same amount of placebo fluid (Noncarb Group).

The aim of this study is to determine the effect of carbonhydrate rich solutions on quality of recovery of parturients undergoing elective CD with Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 18 years old and over
• Term singleton pregnancy
• Undergoing planned caesarean delivery at Karaman Training and Research Hospital
• Patients who have given informed written consent

Exclusion criteria

• Patients who have refused, are unable to give or have withdrawn consent
• Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater
• Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse
• Patients who have refused spinal anesthesia, or those in whom it is contraindicated.
• Pregnancy with preeclampsia or eclampsia
• Pregnancy with gestational diabetes mellitus or diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Experimental ( Carb Group)

Active Comparator group

Description:

Preoperative education will be provided by researchers to the patients on the ward before fluid intake.Solid food and drinking will be forbidden after 24:00 p.m the day before surgery. The Carb group will consume carbonhydrate fluid two hours before the surgery.

Treatment:

Drug: Carbohydrate

Standard Care (Non-carb Group)

Placebo Comparator group

Description:

Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food and drinking will be forbidden after 24:00 p.m the day before surgery.The Non-carb Group will consume same amount of placebo fluid as Carb Group two hours before the surgery

Treatment:

Drug: Placebo