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Randomized Controlled Clinical Study on the Impact of Warmed Ropivacaine vs. Room Temperature Ropivacaine on Early Mobilization after Knee Arthroplasty

Randomized Controlled Clinical Study on the Impact of Warmed Ropivacaine vs. Room Temperature Ropivacaine on Early Mobilization after Knee Arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099261
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-03-20
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Knee arthropathy

Interventions

Control group:Administer 10-13mg of ropivacaine at room temperature during subarachnoid anesthesia.
Experimental group:During subarachnoid anesthesia, 10-13 mg of warmed ropivacaine (at 37?) is administered.

Sponsors

Affiliated Hospital of Yan'an University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age<=75 years; 2.ASA II~III level; 3.18kg/m^2<=BMI<=30kg/m^2; 4. Unilateral knee replacement surgery; 5. Neuraxial anesthesia is planned.

Exclusion criteria

Exclusion criteria: 1. Inability to take care of oneself before surgery; 2. History of delirium before surgery; 3. Combined with mental illness such as dementia; 4. Preoperative albumin =10 mmol/L; 7. Poorly controlled hypertension; Preoperative blood pressure >=140/90; 8. Deep vein thrombosis before surgery; 9. Preoperative fractures in other parts; 10. Refusal to sign the study informed consent form.

Design outcomes

Primary

MeasureTime frame
The distance walked during the 6-minute walk test (6MW) when the patient takes the first ambulation out of bed after the operation.;The early ambulation rate of patients in this group was significantly higher than that in the control group.(.);

Secondary

MeasureTime frame
Onset time of sensory nerve block;The highest block level;Whether epidural supplementation is carried out during the operation and the dosage of the supplementary drug;The incidence of intraoperative hypotension;The satisfaction degree of surgeons with muscle relaxation during the operation;Muscle strength rating upon arrival at the PACU after the end of the operation;The catheterization rate;The flexion degree of the knee joint at 6h, 12h, 24h and 48h after the operation.;The time of the first ambulation after surgery;The incidence of postoperative nausea and vomiting;The incidence of postoperative orthostatic hypotension;VAS scores at rest and during movement at 12 hours, 24 hours and 48 hours after surgery;The effective pressing times of PCIA within 24 hours after surgery and the total amount of opioids used within 24 hours after surgery;The occurrence of postoperative complications (delirium, cardiovascular complications, pulmonary complications, lower extremity deep vein thrombosis).;The time of the first drinking and eating after surgery.;The length of postoperative hospital stay;At 30 days after surgery, the Visual Analogue Scale (VAS) and Lower Extremity Functional Scale (LEFS) were used to evaluate the pain intensity and functional ability;

Countries

China

Contacts

Public ContactZhang Erfei

Affiliated Hospital of Yan'an University

zhangerfei09@126.com+86 138 9117 0975

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026