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

Early Phase 1

Not yet recruiting

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

• Registration Number: NCT05867264
• Lead Sponsor: Hongwei Shi

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-08
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-19
• Last Update Posted: 2023-05-19
• Study Start: 2023-05-25
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 672

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insulin resistance index at fasting	1 day after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of reflux aspiration and hypoxemia	24 hours after surgery	Reflux aspiration is defined as severe cough followed by hypoxemia and lung rale after vomiting. Hypoxemia is defined as SpO2\<91% under air inhalation.
The incidence and severity of various adverse events （AE） from the start of oral carbohydrates until the end of the trial	Up to 48 hours postoperative	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.
Insulin resistance index at fasting	3 days after surgery	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.
Incidence of postoperative nausea and vomiting	Up to 48 hours postoperative	The lower the incidence and severity of postoperative nausea and vomiting, indicating that early administration of carbohydrates after surgery is beneficial.
The extent of the postoperative pain	Up to 48 hours postoperative	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.
Patient satisfaction score	Up to 48 hours postoperative	Rated on a 0-10 scale, with a higher score representing greater satisfaction.
The 15-item recovery quality rating scale （QoR-15）	Up to 48 hours postoperative	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.
The NRS score for the thirst thirst and hunger.	2 hours, 6 hours and 8 hours after surgery	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.
Pre albumin levels and retinol binding protein levels	on the day of surgery, 1 day and 3 days after surgery.	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.
The degree of abdominal distension	24 hours after surgery	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.
Anal exhaust time	Up to 48 hours postoperative	The advanced time of the first postoperative anal exhaust indicates a favorable early postoperative carbohydrate administration.
Hospitalization time	Up to 7days postoperative	The shortened length of hospital stay indicated that early postoperative carbohydrate administration was advantageous.
Number of antiemetic uses	Up to 24 hours after the first start of drug administration.	The less use of antiemetic drugs within 24h after the first start of postoperative administration indicates that early postoperative carbohydrate administration is advantageous.