Skip to content

Effect of S-Ketamine on Hyperalgesia After Staged Bilateral Arthroplasty: A Randomized Controlled Trial

Effect of S-Ketamine on Hyperalgesia After Staged Bilateral Arthroplasty: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125834
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Postoperative pain

Interventions

Experimental Group (esketamine):First operation: After venous access was established, the patient underwent neuraxial anesthesia (spinal anesthesia combined with epidural anesthesia) plus saphenous ne
Control Group (normal saline):First operation and second operation: An equal volume of 0.9% sodium chloride injection was used instead of esketamine intraoperatively and postoperatively. The PCIA form

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old; 2. ASA classification Grade I-III; 3. To be scheduled for staged bilateral total knee arthroplasty under spinal anesthesia on an elective basis within one year; 4. Patients voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to esketamine, ropivacaine, or other local anesthetics. 2. Absolute or relative contraindications to neuraxial anesthesia (e.g., coagulopathy, infection at the puncture site, intracranial hypertension, etc.). 3. History of long-term opioid use (>3 months) or opioid use disorder. 4. Severe hepatic insufficiency (e.g., alanine transaminase/aspartate transaminase > 2×upper limit of normal, elevated bilirubin, prothrombin time 180 mmHg and/or diastolic blood pressure > 110 mmHg). 6. History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) or use of monoamine oxidase inhibitors (MAOIs) within the past 1 month. 7. History of open surgery or severe trauma on the ipsilateral knee. 8. Moderate to severe chronic pain not originating from the knee before surgery (resting NRS score > 6); or concurrent neuropathic pain other than knee arthritis.

Design outcomes

Primary

MeasureTime frame
Area under the curve of mechanical pain threshold at 6, 12, 24, 48, and 72 hours after the second operation.;

Secondary

MeasureTime frame
Area under the curve of mechanical pain threshold at 6, 12, 24, 48, and 72 hours after the first operation.;Incidence of mechanical allodynia at 24 hours after surgery;Mechanical pain threshold before the second operation;Incidence of central sensitization;NRS pain score;Cumulative postoperative opioid consumption;Extra rescue analgesic dosage;Incidence of rebound pain;Quality of Recovery-15 (QoR-15) score;Sleep quality;Time to first patient-controlled analgesia (PCA) bolus;Incidence of chronic postsurgical pain (CPSP);Hospitalization cost;Postoperative length of hospital stay;

Countries

China

Contacts

Public ContactWei Feng

The Affiliated Hospital of Qingdao University

qymzxl@126.com+86 536 8291 9395

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026