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A Prospective, Randomized, Double-blind, Parallel-group Controlled Study on the Use of Ropivacaine Combined with Ascorbic Acid for Local Intraoperative Infiltration Injection for Pain Management and Safety in Hip Arthroplasty Surgery

A Prospective, Randomized, Double-blind, Parallel-group Controlled Study on the Use of Ropivacaine Combined with Ascorbic Acid for Local Intraoperative Infiltration Injection for Pain Management and Safety in Hip Arthroplasty Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122546
Enrollment
Unknown
Registered
2026-04-15
Start date
2026-04-17
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pain after total hip replacement

Interventions

Ropivacaine + normal saline group :Local infiltration injection of ropivacaine + normal saline at the incision site
Ropivacaine + dexamethasone group:Local infiltration injection of ropivacaine and dexamethasone at the incision site
Ropivacaine + ascorbic acid group:Local infiltration injection of ropivacaine + ascorbic acid at the incision site

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. After fully informing about the benefits and risks of the trial, they agreed to participate in the trial and voluntarily signed the informed consent form; 2. Age between 30 and 70 years old; 3. Have obvious hip joint pain accompanied by movement impairment, and the imaging results indicate end-stage hip joint disease, requiring a first-time total hip replacement; 4. Conservative treatment has been ineffective for at least 3 months, and the conservative treatment includes physical therapy, pain medication treatment and joint cavity injection; 5. American Society of Anesthesiologists Physical Status Classification (ASA) is level I-II; 6. Can independently use the patient-controlled analgesia pump (PCA).

Exclusion criteria

Exclusion criteria: 1. Patients with autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.); 2. Patients with hip joint deformity or stiffness, patients undergoing hip joint revision; 3. Known allergies to the test drugs (dexamethasone, ascorbic acid, ropivacaine, Celebrex, diclofenac sodium); 4. Ischemic heart disease, bradycardia (heart rate 35), liver and kidney dysfunction); 6. Patients who have been taking hormones or sedative analgesic drugs for a long time; 7. Active or chronic systemic infections throughout the body, such as AIDS, syphilis, hepatitis, etc.; 8. Severe mental disorders (psychosis, severe emotional disorders or schizophrenia); 9. Recent or past history of alcohol, opioid or anesthetic drug dependence; 10. Pregnant or preparing to become pregnant; 11. Unable to operate the PCA device or unable to answer the pain questionnaire due to mental or physical reasons.

Design outcomes

Primary

MeasureTime frame
The total dosage of opioid drugs used in patient-controlled analgesia (PCA) within 48 hours after the operation;The NRS pain scores at 12 hours and 24 hours after the operation;

Secondary

MeasureTime frame
The time from the end of the surgery to the first press of the PCA analgesic pump;Postoperative Harris score of patients undergoing hip joint replacement;Inflammatory indicators during the perioperative period (C-reactive protein, erythrocyte sedimentation rate, interleukin-6);

Countries

China

Contacts

Public ContactLi Wenkai

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

2016tj0163@hust.edu.cn+86 135 5410 1116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026