Clinical trial NCT05867264: Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty
Official title: Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty: a Randomized, Single-blind, Parallel-controlled, Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Postoperative Oral Carbohydrates
Postoperative Recovery
Unilateral Knee Arthroplasty
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insulin resistance index at fasting
timeFrame: 1 day after surgery
Secondary outcomes:
measure: Insulin resistance index at fasting
timeFrame: on the day of the surgery
measure: Insulin resistance index at fasting
timeFrame: 3 days after surgery
measure: Pre albumin levels and retinol binding protein levels
timeFrame: on the day of surgery, 1 day and 3 days after surgery.
measure: The 15-item recovery quality rating scale （QoR-15）
timeFrame: Up to 48 hours postoperative
measure: The NRS score for the thirst thirst and hunger.
timeFrame: 2 hours, 6 hours and 8 hours after surgery
measure: The degree of abdominal distension
timeFrame: 24 hours after surgery
measure: Incidence of reflux aspiration and hypoxemia
timeFrame: 24 hours after surgery
measure: Anal exhaust time
timeFrame: Up to 48 hours postoperative
measure: Incidence of postoperative nausea and vomiting
timeFrame: Up to 48 hours postoperative
measure: Hospitalization time
timeFrame: Up to 7days postoperative
measure: The extent of the postoperative pain
timeFrame: Up to 48 hours postoperative
measure: Patient satisfaction score
timeFrame: Up to 48 hours postoperative
measure: The incidence and severity of various adverse events （AE） from the start of oral carbohydrates until the end of the trial
timeFrame: Up to 48 hours postoperative
measure: Number of antiemetic uses
timeFrame: Up to 24 hours after the first start of drug administration.
Other outcomes:
Locations:
Study officials:
References:
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