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RECRUITING
NCT07767383
PHASE4

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

Sponsor: Affiliated Hospital of Nantong University

View on ClinicalTrials.gov

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?

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2026-01-15

Completion Date

2026-12-31

Last Updated

2026-08-17

Healthy Volunteers

Yes

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.

Locations (1)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China