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Intravenous Versus Perineural Effect Dexamethasone in Popliteal and Saphenous Nerve Blocks With Ropivacaine in foot and ankle surgery: a prospective, double-blind, randomized controlled trial

Intravenous Versus Perineural Effect Dexamethasone in Popliteal and Saphenous Nerve Blocks With Ropivacaine in foot and ankle surgery: a prospective, double-blind, randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043561
Enrollment
Unknown
Registered
2021-02-21
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-14

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

Conditions

Foot and ankle surgery

Interventions

control group:0.375% ropivacaine 30ml+ 2 mL of systemic saline solution
PNDex group:PNDex group = 30 mL ropivacaine 0.375% + perineural dexamethasone 7.5 mg + 2 mL of systemic saline solution
IVDex group :30 mL ropivacaine 0.375% + intravenous dexamethasone 10 mg (2 mL)

Sponsors

Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years who are going to undergo elective ankle surgery under general anesthesia in Beijing Tongren Hospital; 2. ASA 1-3 subjects; 3. For those subjects who underwent single foot surgery, the estimated operation time was 0-3 hours; 4. Subjects with BMI of 18-30 kg / m; 5. The subjects who agreed to participate in this study signed the informed consent before operation.

Exclusion criteria

Exclusion criteria: 1. Subjects with contraindications to anesthesia (coagulation disorder, puncture site infection, allergy to general or local anesthetics); 2. Subjects with predictable difficult airway; 3. Subjects with central or peripheral neuropathy; 4. Pregnant women and lactating women; 5. Patients with long-term opioid use; 6. Patients with abnormal liver and kidney function: ALT and / or ast > 2 x ULN, or TBIL >= 1.5 x ULN Serum creatinine > 112 µ Or received dialysis treatment within 28 days before operation 7. Patients with diabetes who were not satisfactorily controlled (fasting glucose > 11mmol/L) during screening period 8. Subjects who participated in other clinical trials within 30 days; 9. Patients with tumor; 10. Patients with Charcot osteoarthropathy; 11. Patients with a long history of hormone use.

Design outcomes

Primary

MeasureTime frame
the duration of analgesia defined as the time between the performance of the block to the first patient sellf-reported pain;he duration of analgesia defined as the time between the performance of the ankle block and the first administration of analgesia with PCA;

Secondary

MeasureTime frame
PACU, 2, 6, 12, 24, 36, 48 VAS pain score;adverse effect( itch, dizzy,nausa,consciousness, retention of urine);analgesic need in 24 and 48h;overall satisfaction;adverse effects of nerve block;

Countries

China

Contacts

Public ContactGuyan Wang

Tongren Hospital, Capital Medical University

guyanwang2006@163.com+86 13910985139

Outcome results

None listed

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