Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty

Hongwei Shi

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Unilateral Knee Arthroplasty; Postoperative Recovery; Postoperative Oral Carbohydrates

Treatments: Other: Early drinking water; Combination Product: Early consumption of carbohydrates; Other: Late feeding group

Study type: Interventional

Funder types: Other

Identifiers

NCT05867264

Nanjing First Hospital

Details and patient eligibility

About

To evaluate the effect of early postoperative oral carbohydrate on postoperative recovery of the unilateral knee arthroplasty

Full description

Currently, most clinical studies on the impact of oral carbohydrates on postoperative recovery are focused on the preoperative stage, with only a few small sample studies indicating that postoperative oral carbohydrates can improve patient comfort. Orthopedic surgery, especially joint surgery, requires patients to start functional exercise as soon as possible after surgery. Joint replacement surgery requires reducing the consumption of muscle tissue caused by protein breakdown. Perioperative nutritional support for patients is of great significance for postoperative muscle function recovery and good functional exercise. However, further systematic research on the impact of early postoperative oral carbohydrates on postoperative recovery is still lacking.

This study selected patients who underwent unilateral total knee arthroplasty or single condylar arthroplasty. All surgical patients undergo homogenized preoperative preparation and intraoperative anesthesia management. Eligible patients were screened before surgery, and an informed consent form was signed. Patients enrolled in the experiment were randomly assigned into one of the three groups. They are the early feeding group (EOF1, EOF2group) and the late feeding group （control group）. Evaluate the effectiveness and safety of early postoperative feeding （EOF） in orthopedic surgery patients by measuring indicators such as insulin resistance index, QoR-15, and prealbumin and retinol binding protein.

Enrollment: 672 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-79 years.
• Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
• Normal diet.
• ASA grade I~Ⅲ;
• BMI 18-30kg /m2.
• No intraspinal anesthesia contraindications.

Exclusion criteria

• Preoperative existence of gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery.
• Patients with diabetes mellitus, severe renal dysfunction, or other severe metabolic diseases.
• History of motion sickness.
• Mental disorder, alcoholism, or a history of substance abuse.
• Patients with abnormal swallowing function.
• The operation time is greater than 3 hours.
• Maltodextrin fructose allergy or intolerance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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672 participants in 3 patient groups, including a placebo group

EOF 1 group：Early drinking water group

Placebo Comparator group

Description:

After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water.

Treatment:

Other: Early drinking water

EOF 2 group: Early oral carbohydrate group

Experimental group

Description:

After passing the evaluation by the anesthesiologist team in PACU, the EOF2 group had a drinking capacity of 200ml of 12.5% carbohydrates (100ml containing 12.5g of maltodextrin, fructose, and glucose).

Treatment:

Combination Product: Early consumption of carbohydrates

Control group: Late feeding group

Placebo Comparator group

Description:

After observing the vital signs for 30 minutes after surgery, patients in Group C were sent back to the ward to continue fasting and drinking for at least 6 hours. After the anus exhausts, they began to gradually drink and eat

Treatment:

Other: Late feeding group