Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction

Condition(s) studied

Investigational drug(s) / intervention(s)

Experimental-Active taVNS: Transcutaneous auricular vagus nerve stimulation (taVNS) delivered via electrodes placed on left cymba concha. Stimulus parameters: 20 Hz frequency, pulse width 250 μs. Current is slowly increased to the subject's threshold of non-painful tingling and then reduced to sub-threshold level. Three 30-minute stimulation sessions are performed: 30-45 minutes pre-operatively, 6±1 hours post-operation, and 18±1 hours post-operation. All participants receive standardized spinal anesthesia, adductor canal block, multimodal postoperative analgesia and postoperative rehabilitation protocol.

Sham transcutaneous auricular vagus nerve stimulation: Using the same equipment, the same position of the left cymba concha, and the same 30-minute timing. Each time, the current is slowly increased within 30 seconds at the beginning until the first clear but non-painful slight tingling sensation is achieved; then it is gradually reduced to 0 mA within 15 to 30 seconds, and remains at 0 mA for the rest of the time, while the screen, timing, and alert sounds continue to operate. Study participants in both groups are informed that stimulation sensation may weaken or disappear with adaptation and that sensation intensity cannot be used to determine group assignment. Anesthesia, block, postoperative analgesia, and rehabilitation training are all exactly the same as the experimental group.

Study summary

Background: Arthroscopic anterior cruciate ligament reconstruction (ACLR) is a common orthopedic surgery. Postoperative pain, inflammatory response and opioid-related adverse events impair early recovery quality. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique with potential analgesic and anti-inflammatory effects.

Participants: A total of 144 eligible participants undergoing ACLR under spinal anesthesia combined with an adductor canal block will be enrolled.

Methods: This prospective, randomized, double-blind, sham-controlled trial will evaluate the effects of perioperative taVNS on early postoperative recovery. Participants will be randomly assigned in a 1:1 ratio to receive active taVNS or sham stimulation. Each participant will receive three 30-minute stimulation sessions, scheduled 30-45 minutes before surgery, 6 ± 1 hours after surgery, and 18 ± 1 hours after surgery. All participants will receive standardized multimodal postoperative analgesia. The primary outcome will be the score on the 15-item Quality of Recovery (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes will include rescue opioid consumption expressed as oral morphine equivalents, pain scores measured using the Numeric Rating Scale (NRS), functional recovery, and adverse events.

Conclusion: The investigators hypothesize that perioperative taVNS will improve early postoperative recovery quality after ACLR.

Eligibility

Primary outcome measure(s)

• Quality of Recovery-15 (QoR-15) score — 24 hours after surgery
  Validated 15-item patient-reported questionnaire assessing postoperative recovery quality. Total score ranges from 0-150; higher score indicates better postoperative recovery quality.

Trial sites (1)

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