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Comparison of epidural analgesia and intravenous controlled analgesia on pain and recipient site complications after reconstruction of the ALTP flap in patients with diabetic foot ulcers: a randomized controlled clinical trial

Comparison of epidural analgesia and intravenous controlled analgesia on pain and recipient site complications after reconstruction of the ALTP flap in patients with diabetic foot ulcers: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062584
Enrollment
Unknown
Registered
2022-08-12
Start date
2022-08-10
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Diabetic foot ulcers

Interventions

PICA group:Intravenous controlled analgesia
EDA group:Epidural analgesia

Sponsors

Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Above 18 years old, below 70 years old; 2. Wagner grade >= ?grade; 3. DFUs patients meeting ALTPF indications, including wounds involving bone, tendon, blood vessels, nerves, and other important structures exposed; For DFUs patients with PAD, vascular revascularization or interventional therapy was followed by ALTPF; 4. Accept elective ALTPF reconstruction of DFUs and agree to participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1. Patients with ASA grade IV or above and hemodynamic instability; 2. Severe systemic infection; 3. Hypovolemia; 4. EA or EDA or PCIA contraindications (such as ropivacaine allergy, epidural area infection, coagulation dysfunction, spinal malformation or history of previous surgery or trauma, spinal tuberculosis, central nervous system diseases, etc.); 5. End-stage renal disease (undergoing dialysis or serum creatinine > 2.5mg/dL or 221mmol/L); 6. Severe chronic obstructive pulmonary disease (GOLD >= stage III); 7. The subject participated in another clinical research trial within the past 30 days; 8. Pregnant women.

Design outcomes

Primary

MeasureTime frame
Pain;Recipient complication;

Secondary

MeasureTime frame
Mortality;amputation;Lower limb deep venous thrombosis;Pulmonary thromboembolism ;Maximal flow velocity of anastomosed artery;Postoperative pain assessment;Donor-site Complications;Complications of epidural anesthesia or PCEA;Number of secondary operations;Postoperative anticoagulant drugs;The operation time;Hospital stay;PCIA complications;mean arterial pressure(MAP);Intraoperative vasoactive drugs;Postoperative vasoactive drugs;Fluids given intraoperatively;Fluids given intraoperatively;Hospitalization expenses;Postoperative comfort of patients;

Countries

China

Contacts

Public ContactWei Zairong
zairongwei@163.com+86 15208660008

Outcome results

None listed

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