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Comparison of anesthetic technique between Sedation with Femoral-Popliteal Sciatic Nerve Block Versus General Anesthesia During Percutaneous Transluminal Angioplasty: A randomized controlled trial

Comparison of anesthetic technique between Sedation with Femoral-Popliteal

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250102005
Enrollment
52
Registered
2025-01-02
Start date
2025-01-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients diagnosed with chronic limb-threatening ischemia of lower extremities scheduled for elective percutaneous transluminal angioplasty. percutaneous transluminal angioplasty, chronic limb-threatening ischemia, Femoral-Popliteal Sciatic Nerve Block, General Anesthesia

Interventions

Femoral nerve block and popliteal sciatic nerve block using 0.33% bupivacaine total 30 ml and sedation with propofol to maintain BIS level 60-80.,General anesthesia with endotracheal intubation, using
Experimental Procedure/Surgery,No Intervention Procedure/Surgery
Femoral-Popliteal nerve block with sedation,General anesthesia

Sponsors

Ramathibodi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with chronic limb-threatening ischemia of lower extremities scheduled for elective percutaneous transluminal angioplasty.

Exclusion criteria

Exclusion criteria: Decline or withdraw from study Hypersensitivity to local anesthetic agents Infection at skin local site Pre-existing hypotensive shock (MAP<65) Pre-existing vasopressor use Emergency case Preexisting neuropathy Coagulopathy with abnormal bleeding Age > 65 years old with Mini-cog (S.Borson) score <= 3, indicating cognitive impairment

Design outcomes

Primary

MeasureTime frame
Incidence of hypotensive events during entire intraoperative period frequency and severity of hypotension

Secondary

MeasureTime frame
perioperative pain scores 24 hours Verbal Numerical Rating Scale ,surgeon satisfaction score immediate postoperative period score 0-5,patient satisfaction score 24 hours score 0-5,leg or foot movement during entire intraoperative period frequency of movement,cumulative doses of vasopressor during entire intraoperative period milligram of drugs used

Countries

Thailand

Contacts

Public ContactNapat Tovanakasame

Ramathibodi Hospital

napat.toa@student.mahidol.ac.th022011513

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026