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Knee Arthroscopic SurgeryPhase 4NCT07767383

Effect of Dexmedetomidine Combined With FNB/ACB on Sleep Quality After Knee Surgery

A Phase 4 study testing ropivacaine (local infiltration), Dexmedetomidine and Femoral Nerve Block in people with Knee Arthroscopic Surgery, run by Affiliated Hospital of Nantong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Knee Arthroscopic Surgery
What is being tested?
ropivacaine (local infiltration), Dexmedetomidine and Femoral Nerve Block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
1 siteChina
Study dates
15 Jan 2026to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 to 85 years.
  • American Society of Anesthesiologists (ASA) physical status I to III.
  • Body Mass Index (BMI) between 18 and 30 kg/m² and body weight > 50 kg.
  • Scheduled for elective knee arthroscopy under general anesthesia.
  • Complete preoperative workup, confirmed diagnosis, and indication for knee arthroscopy with complete postoperative medical records.
  • Normal mental and cognitive status.
  • Patient or legally authorized representative has provided written informed consent for anesthesia and study participation.

Who cannot join

  • Refusal to participate in the study.
  • Inability to communicate effectively.
  • Known allergy or contraindication to any study drug (ropivacaine, dexmedetomidine, propofol, sufentanil, remifentanil, vecuronium, or sevoflurane).
  • 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).
  • Coagulation disorders or local infection at the puncture site precluding peripheral nerve block.
  • Severe hepatic or renal dysfunction.
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  • Severe cardiopulmonary insufficiency.
  • Pregnancy.
  • Diagnosis of obstructive sleep apnea (OSA) or requirement for continuous positive airway pressure (CPAP) therapy.
  • 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.
  • Pittsburgh Sleep Quality Index (PSQI) score > 5.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ma XQ Ma Xia Qing, doctorate contact

0086-18118660387

lvy_Ma@ntu.edu.cn

China1 site, 1 recruiting
  • The Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 211600

    Ma XQ Ma Xia Qing, PhD, 18118660387, lvy_Ma@ntu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Effect of Dexmedetomidine Combined With FNB/ACB on Sleep Quality After Knee Surgery: A Randomized Controlled Factorial Trial

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?
Being tested
ropivacaine (local infiltration), Dexmedetomidine, Normal saline placebo, Femoral Nerve Block, Adductor canal block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ropivacaine (local infiltration)Drug

    0.375% ropivacaine solution, 20 mL, administered as a single-shot peripheral nerve block prior to anesthesia induction.

  • DexmedetomidineDrug

    0.5 μg/(kg·h) continuous intravenous infusion, initiated after anesthesia induction and discontinued 30 minutes before the end of surgery.

  • Normal saline placeboDrug

    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.

  • Femoral Nerve BlockProcedure or surgery

    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.

  • Adductor canal blockProcedure or surgery

    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.

Study groups in NCT07767383
Study groupRoleWhat they receive
FNB + PlaceboExperimentalFemoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg/(kg·h) as placebo.
Receives: Drug: ropivacaine (local infiltration); Drug: Normal saline placebo; Procedure: Femoral Nerve Block
FNB + DexmedetomidineExperimentalFemoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).
Receives: Drug: ropivacaine (local infiltration); Drug: Dexmedetomidine; Procedure: Femoral Nerve Block
ACB + PlaceboExperimentalAdductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg/(kg·h) as placebo.
Receives: Drug: ropivacaine (local infiltration); Drug: Normal saline placebo; Procedure: Adductor canal block
ACB + DexmedetomidineExperimentalAdductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).
Receives: Drug: ropivacaine (local infiltration); Drug: Dexmedetomidine; Procedure: Adductor canal block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh Sleep Quality Index (PSQI) scores at 24 hours after 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.

    Measured: 24 hours post-surgery

Secondary outcomes (22)
  1. Pittsburgh Sleep Quality Index (PSQI) scores at 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.

    Measured: 48 hours after surgery

  2. Richards-Campbell Sleep Questionnaire (RCSQ) Score at 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.

    Measured: 24 hours after surgery

  3. Richards-Campbell Sleep Questionnaire (RCSQ) Score at 48 Hours After 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.

    Measured: 48 hours post-surgery

  4. Resting Pain Numeric Rating Scale Score at 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.

    Measured: 6 hours after surgery

  5. Resting Pain Numeric Rating Scale Score at 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.

    Measured: 24 hours after surgery

  6. Resting Pain Numeric Rating Scale Score at 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.

    Measured: 48 hours after surgery

  7. Movement Pain Numeric Rating Scale Score at 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.

    Measured: 6 hours after surgery

  8. Movement Pain Numeric Rating Scale Score at 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.

    Measured: 24 hours after surgery

  9. Movement Pain Numeric Rating Scale Score at 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.

    Measured: 48 hours after surgery

  10. Total Sufentanil Consumption

    Total sufentanil consumption delivered through patient-controlled intravenous analgesia will be recorded in micrograms. Higher consumption indicates greater postoperative opioid requirement.

    Measured: 0 to 24 hours

  11. Quality of Recovery-15 (QoR-15) score at 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.

    Measured: 24 hours after surgery

  12. Quality of Recovery-15 (QoR-15) score at 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.

    Measured: 48 hours after surgery

  13. Modified Bromage score at 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.

    Measured: 6 hours after surgery

  14. Modified Bromage score at 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.

    Measured: 24 hours after surgery

  15. Quadriceps Muscle Strength Score at 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.

    Measured: 6 hours after surgery

  16. Quadriceps Muscle Strength Score at 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.

    Measured: 24 hours after surgery

  17. Quadriceps Muscle Strength Score at 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.

    Measured: 48 hours after surgery

  18. Time to First Assisted Ambulation

    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.

    Measured: From the end of surgery to first assisted ambulation, assessed up to 48 hours after surgery

  19. Mini-Mental State Examination (MMSE) score

    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.

    Measured: Baseline and 24 hours after surgery

  20. Incidence of Postoperative Nausea and Vomiting

    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.

    Measured: 0 to 48 hours after surgery

  21. Proportion of Participants Requiring Rescue Analgesia

    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.

    Measured: From the end of surgery through 48 hours after surgery

  22. Incidence of Perioperative Adverse Events

    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.

    Measured: From the start of anesthesia to 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start15 Jan 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07767383
Sponsor's protocol ID
2026-K092-02
Status last verified
Jan 2026
First submitted
19 Jun 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ropivacaine (local infiltration), Dexmedetomidine and Femoral Nerve Block in people with Knee Arthroscopic Surgery, run by Affiliated Hospital of Nantong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ma XQ Ma Xia Qing, doctorate (0086-18118660387, lvy_Ma@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (PSQI) scores at 24 hours after surgery (time frame: 24 hours post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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