Effect of Dexmedetomidine Combined With FNB/ACB on Sleep Quality After Knee Surgery
NCT07767383 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2026-08-17
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?
Conditions
- Knee Arthroscopic Surgery
Interventions
- DRUG
-
ropivacaine (local infiltration)
0.375% ropivacaine solution, 20 mL, administered as a single-shot peripheral nerve block prior to anesthesia induction.
- DRUG
-
Dexmedetomidine
0.5 μg/(kg·h) continuous intravenous infusion, initiated after anesthesia induction and discontinued 30 minutes before the end of surgery.
- DRUG
-
Normal 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.
- PROCEDURE
-
Femoral 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.
- PROCEDURE
-
Adductor 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 & Collaborators
-
Affiliated Hospital of Nantong University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-15
- Primary Completion
- 2026-09-30
- Completion
- 2026-12-31
Countries
- China
Study Locations
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