Knee Arthroscopic Surgery
Conditions
Brief summary
The goal of this randomized, double-blind, placebo-controlled, 2×2 factorial trial is to evaluate the effect of intraoperative dexmedetomidine combined with either femoral nerve block (FNB) or adductor canal block (ACB) on postoperative sleep quality in patients aged 18-85 years with ASA I-III undergoing elective knee arthroscopy under general anesthesia. The main questions it aims to answer are: 1. Does intraoperative dexmedetomidine infusion (0.5 μg/kg/h) improve postoperative sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) at 24 h and 48 h after surgery? 2. Is there an interaction between the type of nerve block (FNB vs. ACB) and the use of dexmedetomidine on postoperative sleep quality?
Interventions
0.375% ropivacaine solution, 20 mL, administered as a single-shot peripheral nerve block prior to anesthesia induction.
DRUGDexmedetomidine
0.5 μg/(kg·h) continuous intravenous infusion, initiated after anesthesia induction and discontinued 30 minutes before the end of surgery.
DRUGNormal saline placebo
0.9% normal saline solution, administered as a continuous intravenous infusion at a volume rate matching the dexmedetomidine group (0.5 μg/kg/h equivalent), started after induction and stopped 30 minutes before surgery end.
PROCEDUREFemoral Nerve Block
Ultrasound-guided femoral nerve block performed at the inguinal region (approximately 2 cm distal to the inguinal ligament) using an in-plane technique. A total of 20 mL of 0.375% ropivacaine is injected 1-2 mm anterior to the femoral nerve.
PROCEDUREAdductor canal block
Ultrasound-guided adductor canal block performed via the distal approach at the mid-to-lower third of the medial thigh, targeting the adductor hiatus. A total of 20 mL of 0.375% ropivacaine is injected.
Sponsors
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 to 85 years. 2. American Society of Anesthesiologists (ASA) physical status I to III. 3. Body Mass Index (BMI) between 18 and 30 kg/m² and body weight \> 50 kg. 4. Scheduled for elective knee arthroscopy under general anesthesia. 5. Complete preoperative workup, confirmed diagnosis, and indication for knee arthroscopy with complete postoperative medical records. 6. Normal mental and cognitive status. 7. Patient or legally authorized representative has provided written informed consent for anesthesia and study participation.
Exclusion criteria
1. Refusal to participate in the study. 2. Inability to communicate effectively. 3. Known allergy or contraindication to any study drug (ropivacaine, dexmedetomidine, propofol, sufentanil, remifentanil, vecuronium, or sevoflurane). 4. History of knee trauma or knee surgery; diagnosed with immune system disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus); neuromuscular diseases or psychiatric disorders; restless legs syndrome (RLS); periodic limb movement disorder (PLMD). 5. Coagulation disorders or local infection at the puncture site precluding peripheral nerve block. 6. Severe hepatic or renal dysfunction. 7. Severe cardiopulmonary insufficiency. 8. Pregnancy. 9. Diagnosis of obstructive sleep apnea (OSA) or requirement for continuous positive airway pressure (CPAP) therapy. 10. Regular use of sedative-hypnotic drugs (benzodiazepines, non-benzodiazepine hypnotics, melatonin receptor agonists, etc.) or antidepressants/anxiolytics known to affect sleep architecture (e.g., trazodone, mirtazapine) within the past 1 month. 11. Pittsburgh Sleep Quality Index (PSQI) score \> 5.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) scores at 24 hours after surgery | 24 hours post-surgery | Sleep quality at 24 hours after surgery will be assessed using the Pittsburgh Sleep Quality Index. The unit of measure is points on a scale. The Pittsburgh Sleep Quality Index includes 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component score ranges from 0 to 3. The global Pittsburgh Sleep Quality Index score is calculated as the sum of the 7 component scores, resulting in a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Requiring Rescue Analgesia | From the end of surgery through 48 hours after surgery | The outcome will be calculated as the proportion of participants who require at least one dose of rescue analgesic medication because the pain score remains greater than 4 despite patient-controlled analgesia. The proportion will be calculated as the number of participants requiring rescue analgesia divided by the total number of participants in each group and expressed as a percentage. A higher percentage indicates a greater requirement for additional analgesia. |
| Incidence of Perioperative Adverse Events | From the start of anesthesia to 48 hours after surgery | Perioperative adverse events will include bradycardia, hypotension, respiratory depression, serious arrhythmia, excessive sedation, local anesthetic systemic toxicity, and other clinically significant adverse events. The outcome will be reported as the proportion of participants experiencing at least one predefined adverse event. |
| Mini-Mental State Examination (MMSE) score | Baseline and 24 hours after surgery | Cognitive function will be assessed using the Mini-Mental State Examination. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. |
| Pittsburgh Sleep Quality Index (PSQI) scores at 48 hours after surgery | 48 hours after surgery | Sleep quality at 48 hours after surgery will be assessed using the Pittsburgh Sleep Quality Index. The unit of measure is points on a scale. The Pittsburgh Sleep Quality Index includes 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component score ranges from 0 to 3. The global Pittsburgh Sleep Quality Index score is calculated as the sum of the 7 component scores, resulting in a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality. |
| Richards-Campbell Sleep Questionnaire (RCSQ) Score at 24 Hours After Surgery | 24 hours after surgery | Subjective sleep quality at 24 hours after surgery will be assessed using the Richards-Campbell Sleep Questionnaire. The unit of measure is points on a scale. The questionnaire includes 5 items assessing sleep depth, sleep latency, number of awakenings, time spent awake, and overall sleep quality. Each item is scored from 0 to 100. The final Richards-Campbell Sleep Questionnaire score is calculated as the mean of the 5 item scores. The final score ranges from 0 to 100, with higher scores indicating better sleep quality. |
| Richards-Campbell Sleep Questionnaire (RCSQ) Score at 48 Hours After Surgery | 48 hours post-surgery | Subjective sleep quality at 48 hours after surgery will be assessed using the Richards-Campbell Sleep Questionnaire. The unit of measure is points on a scale. The questionnaire includes 5 items assessing sleep depth, sleep latency, number of awakenings, time spent awake, and overall sleep quality. Each item is scored from 0 to 100. The final Richards-Campbell Sleep Questionnaire score is calculated as the mean of the 5 item scores. The final score ranges from 0 to 100, with higher scores indicating better sleep quality. |
| Resting Pain Numeric Rating Scale Score at 6 Hours After Surgery | 6 hours after surgery | Resting pain intensity will be assessed using an 11-point Numeric Rating Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate more severe pain. |
| Resting Pain Numeric Rating Scale Score at 24 Hours After Surgery | 24 hours after surgery | Resting pain intensity will be assessed using an 11-point Numeric Rating Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate more severe pain. |
| Resting Pain Numeric Rating Scale Score at 48 Hours After Surgery | 48 hours after surgery | Resting pain intensity will be assessed using an 11-point Numeric Rating Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate more severe pain. |
| Movement Pain Numeric Rating Scale Score at 6 Hours After Surgery | 6 hours after surgery | Movement pain intensity will be assessed using an 11-point Numeric Rating Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate more severe pain. |
| Movement Pain Numeric Rating Scale Score at 24 Hours After Surgery | 24 hours after surgery | Movement pain intensity will be assessed using an 11-point Numeric Rating Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate more severe pain. |
| Movement Pain Numeric Rating Scale Score at 48 Hours After Surgery | 48 hours after surgery | Movement pain intensity will be assessed using an 11-point Numeric Rating Scale. The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate more severe pain. |
| Total Sufentanil Consumption | 0 to 24 hours | Total sufentanil consumption delivered through patient-controlled intravenous analgesia will be recorded in micrograms. Higher consumption indicates greater postoperative opioid requirement. |
| Quality of Recovery-15 (QoR-15) score at 24 Hours After Surgery | 24 hours after surgery | Postoperative recovery quality will be assessed using the 15-item Quality of Recovery questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery quality. |
| Quality of Recovery-15 (QoR-15) score at 48 Hours After Surgery | 48 hours after surgery | Postoperative recovery quality will be assessed using the 15-item Quality of Recovery questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery quality. |
| Modified Bromage score at 6 Hours After Surgery | 6 hours after surgery | Motor block will be assessed using the modified Bromage score. The score ranges from 0 to 3, where 0 indicates no motor block and 3 indicates complete motor block. Higher scores indicate greater motor impairment. |
| Modified Bromage score at 24 Hours After Surgery | 24 hours after surgery | Motor block will be assessed using the modified Bromage score. The score ranges from 0 to 3, where 0 indicates no motor block and 3 indicates complete motor block. Higher scores indicate greater motor impairment. |
| Quadriceps Muscle Strength Score at 6 Hours After Surgery | 6 hours after surgery | Quadriceps muscle strength will be assessed using the Medical Research Council muscle strength scale. The score ranges from 0 to 5, where 0 indicates no visible muscle contraction and 5 indicates normal muscle strength. Higher scores indicate better quadriceps muscle strength. |
| Quadriceps Muscle Strength Score at 24 Hours After Surgery | 24 hours after surgery | Quadriceps muscle strength at 24 hours after surgery will be assessed using the Medical Research Council muscle strength scale. The unit of measure is points on a scale. Scores range from 0 to 5, where 0 indicates no visible muscle contraction and 5 indicates normal muscle strength. Higher scores indicate better quadriceps muscle strength. |
| Quadriceps Muscle Strength Score at 48 Hours After Surgery | 48 hours after surgery | Quadriceps muscle strength at 48 hours after surgery will be assessed using the Medical Research Council muscle strength scale. The unit of measure is points on a scale. Scores range from 0 to 5, where 0 indicates no visible muscle contraction and 5 indicates normal muscle strength. Higher scores indicate better quadriceps muscle strength. |
| Incidence of Postoperative Nausea and Vomiting | 0 to 48 hours after surgery | The incidence of postoperative nausea and vomiting will be defined as the proportion of participants who experience nausea or vomiting during the first 48 hours after surgery. |
| Time to First Assisted Ambulation | From the end of surgery to first assisted ambulation, assessed up to 48 hours after surgery | Time to first assisted ambulation is defined as the time from the end of surgery to the first successful assisted ambulation, including sitting up, standing, and walking with assistance. The time will be recorded in hours. A longer time indicates delayed early mobilization. |
Countries
China
Contacts
CONTACTMa XQ Ma Xia Qing, doctorate
Outcome results
None listed