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

NCT07767383 | Recruiting Phase 4

• 1 other identifier: 2026-K092-02
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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. 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. 2.Is there an interaction between the type of nerve block (FNB vs. ACB) and the use of dexmedetomidine on postoperative sleep quality?

Conditions

Knee Arthroscopic Surgery

Outcome Measures

Primary Outcomes (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.

  24 hours post-surgery

Secondary Outcomes (22)

• Pittsburgh Sleep Quality Index (PSQI) scores at 48 hours after surgery

  48 hours after surgery

• Richards-Campbell Sleep Questionnaire (RCSQ) Score at 24 Hours After Surgery

  24 hours after surgery

• Richards-Campbell Sleep Questionnaire (RCSQ) Score at 48 Hours After Surgery

  48 hours post-surgery

• Resting Pain Numeric Rating Scale Score at 6 Hours After Surgery

  6 hours after surgery

• Resting Pain Numeric Rating Scale Score at 24 Hours After Surgery

  24 hours after surgery

Study Arms (4)

FNB + Placebo

EXPERIMENTAL

Femoral 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.

Drug: ropivacaine (local infiltration); Drug: Normal saline placebo; Procedure: Femoral Nerve Block

FNB + Dexmedetomidine

EXPERIMENTAL

Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).

Drug: ropivacaine (local infiltration); Drug: Dexmedetomidine; Procedure: Femoral Nerve Block

ACB + Placebo

EXPERIMENTAL

Adductor 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.

Drug: ropivacaine (local infiltration); Drug: Normal saline placebo; Procedure: Adductor canal block

ACB + Dexmedetomidine

EXPERIMENTAL

Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg/(kg·h).

Drug: ropivacaine (local infiltration); Drug: Dexmedetomidine; Procedure: Adductor canal block

Interventions

ropivacaine (local infiltration) DRUG

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

ACB + Dexmedetomidine; ACB + Placebo; FNB + Dexmedetomidine; FNB + Placebo

Dexmedetomidine DRUG

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

ACB + Dexmedetomidine; FNB + Dexmedetomidine

Normal saline placebo DRUG

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.

ACB + Placebo; FNB + Placebo

Femoral Nerve Block PROCEDURE

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.

FNB + Dexmedetomidine; FNB + Placebo

Adductor canal block PROCEDURE

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.

ACB + Dexmedetomidine; ACB + Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, 211600, China

RECRUITING

MeSH Terms

Interventions

Ropivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ma XQ Ma Xia Qing, doctorate

CONTACT

0086-18118660387; lvy_Ma@ntu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: August 17, 2026
• Study Start: January 15, 2026
• Primary Completion: September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)