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Study on the Temporal Characteristics of Auricular Acupressure Needles in Relieving Postoperative Pain of Ankle Fractures

Study on the Temporal Characteristics of Auricular Acupressure Needles in Relieving Postoperative Pain of Ankle Fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000983
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-02-04
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after ankle fracture surgery

Interventions

Strong Auricular Stimulation Group:True needles vertically inserted subcutaneously after auricular disinfection, alternating ears every 24h with guided daily pressure
Weak Auricular Stimulation Group:Blunted sham needles applied superficially without subcutaneous insertion, no pressure required

Sponsors

Nanjing Medical University Affiliated Hospital No.1
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years (inclusive); 2. Confirmed ankle fracture undergoing ORIF under general anesthesia, enrolled within 6h post-op with VAS=4; 3. TCM diagnosis of "Qi stagnation and blood stasis syndrome" (fixed postoperative pain, local swelling); 4. Conscious and cooperative with assessments; 5. Signed informed consent with commitment to 48h and 30-day follow-up.

Exclusion criteria

Exclusion criteria: 1. Combined fractures or multiple traumas; 2. Preoperative long-term opioid (>2 weeks) or NSAID use (>1 week) with dependency/tolerance; 3. Severe cardiovascular/cerebral/hepatic/renal diseases or psychiatric disorders; 4. Pregnancy/lactation; 5. Needle allergy or syncope history; 6. Local auricular dermatological conditions; 7. Recent participation in other trials or analgesic interventions.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale;

Secondary

MeasureTime frame
Analgesic Usage;Ankle Function Score;Gastrointestinal Symptoms;

Countries

China

Contacts

Public ContactZhou Shuai

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

1197248036@qq.com17766081092

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026