NCT05867264

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

Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty: a Randomized, Single-blind, Parallel-controlled, Multicenter Study

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 672 (estimated)
• Sponsor: Hongwei Shi · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Postoperative Oral Carbohydrates
• Postoperative Recovery
• Unilateral Knee Arthroplasty

Interventions

Type	Name	Description
OTHER	Early drinking water	After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water. The evaluation criteria for the anesthesiologist team are: 1. Steward's awakening score is ≥ 6 points. 2. Level of sobriety ≥ 3. 3. There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery.
COMBINATION_PRODUCT	Early consumption of carbohydrates	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). The evaluation criteria for the anesthesiologist team are: 1. Steward's awakening score is 6 points. 2. Level of sobriety ≥ 3. 3. There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery.
OTHER	Late feeding group	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

Timeline

• Start date: 2023-05-25
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2023-05-19
• Last updated: 2023-05-19