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

Study Overview
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Brief Summary
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To evaluate the effect of early postoperative oral carbohydrate on postoperative recovery of the unilateral knee arthroplasty

Detailed Description
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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.

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

Conditions
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Postoperative Oral Carbohydrates, Postoperative Recovery, Unilateral Knee Arthroplasty

Intervention / Treatment
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* Other: Early drinking water
* Combination Product: Early consumption of carbohydrates
* Other: Late feeding group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: EOF 1 group：Early drinking water group<br>After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water. | Other: Early drinking water<br>* 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: Steward's awakening score is ≥ 6 points. Level of sobriety ≥ 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.<br>|
| Experimental: EOF 2 group: Early oral carbohydrate group<br>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). | Combination Product: Early consumption of carbohydrates<br>* 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: Steward's awakening score is 6 points. Level of sobriety ≥ 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.<br>|
| Placebo Comparator: Control group: Late feeding group<br>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 | Other: Late feeding group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance index at fasting | In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period. | 1 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance index at fasting | In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period. | on the day of the surgery | 
| Insulin resistance index at fasting | In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period. | 3 days after surgery | 
| Pre albumin levels and retinol binding protein levels | The change in prealbumin levels and retinol-binding protein levels in venous blood in a fasting state in the early morning can reflect whether carbohydrate administration is favorable in the early postoperative period. Three of the eight test centers examined the pre-albumin levels and retinol-binding protein levels. | on the day of surgery, 1 day and 3 days after surgery. | 
| The 15-item recovery quality rating scale （QoR-15） | QoR-15 was used to assess five aspects of postoperative recovery quality (physical comfort, physical independence, psychological support, emotion and pain), with higher scores indicating the higher postoperative recovery quality. The lowest score is 0 points, and the highest score is 150 points. | Up to 48 hours postoperative | 
| The NRS score for the thirst thirst and hunger. | The Numerical Rating Scale (NRS) is used to assess the degree of thirst and hunger in patients, with a score of 0 to 10. A score of 0 represents no thirst and no hunger, while a score of 10 represents unbearable thirst and hunger. The thirst and hunger score indicates that early postoperative carbohydrate administration is beneficial. | 2 hours, 6 hours and 8 hours after surgery | 
| The degree of abdominal distension | Using grading method, complaining of abdominal distention, tolerable, feeling gas rolling in the abdomen, no obvious abdominal signs, mild abdominal distension, abdominal distention, moderate abdominal distension, vomiting, dyspnea, and significant abdominal bulge. | 24 hours after surgery | 
| Incidence of reflux aspiration and hypoxemia | Reflux aspiration is defined as severe cough followed by hypoxemia and lung rale after vomiting. Hypoxemia is defined as SpO2<91% under air inhalation. | 24 hours after surgery | 
| Anal exhaust time | The advanced time of the first postoperative anal exhaust indicates a favorable early postoperative carbohydrate administration. | Up to 48 hours postoperative | 
| Incidence of postoperative nausea and vomiting | The lower the incidence and severity of postoperative nausea and vomiting, indicating that early administration of carbohydrates after surgery is beneficial. | Up to 48 hours postoperative | 
| Hospitalization time | The shortened length of hospital stay indicated that early postoperative carbohydrate administration was advantageous. | Up to 7days postoperative | 
| The extent of the postoperative pain | The total amount of sufentanil consumed by the patient 48 hours after operation, the number of effective presses of the analgesia pump, the number of times of rescue analgesia and the amount of rescue drugs were converted into the total amount of morphine. | Up to 48 hours postoperative | 
| Patient satisfaction score | Rated on a 0-10 scale, with a higher score representing greater satisfaction. | Up to 48 hours postoperative | 
| The incidence and severity of various adverse events （AE） from the start of oral carbohydrates until the end of the trial | The lower the incidence and severity of various adverse events (AE) from the start of postoperative oral carbohydrates until the end of the trial, it indicates that the early postoperative carbohydrate administration is beneficial. | Up to 48 hours postoperative | 
| Number of antiemetic uses | The less use of antiemetic drugs within 24h after the first start of postoperative administration indicates that early postoperative carbohydrate administration is advantageous. | Up to 24 hours after the first start of drug administration. |