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The efficacy of the additional local anesthetic peri-femoral artery injection to femoral and sciatic nerve block in reducing the incidence of thigh tourniquet-induced hypertension during lower limbs surgery: A randomized control trial

The efficacy of the additional local anesthetic peri-femoral artery injection to femoral and sciatic nerve block in reducing the incidence of thigh tourniquet-induced hypertension during lower limbs surgery: A randomized control trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210524009
Enrollment
60
Registered
2021-05-24
Start date
2021-09-01
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

tourniquet hypertension in patients undergoing lower limbs surgery tourniquet hypertension, peri-arterial injection, perifemoral artery, tourniquet intolerance, femoral nerve block, sciatic nerve block

Interventions

Drug: 0.25% bupivacaine 15 mL. An ultrasound guided injection of bupivacaine superomedially to the femoral artery.,standard of perioperative care, subcutaneous injection
femoral periarterial block group,subcutaneous infiltration group

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. patients undergoing lower limbs surgery 2. American Society of Anesthesia I-II 3. patients weighted more than 60 kilograms

Exclusion criteria

Exclusion criteria: 1. patient refusal 2. diagnosis of chronic opioid use 3. intolerance or allergy to local anesthetic drugs 4. weight less than 60 kilograms 5. American Society of Anesthesia more than 2 6. pregnancy 7. patients with an inability to communicate pain scores 8. patients with contraindication of applying tourniquets 9. patients with high risks of local anesthetic toxicity 10. patients with uncontrolled hypertension

Design outcomes

Primary

MeasureTime frame
tourniquet hypertension intraoperative Measuring systolic blood pressure using a cuff, aim to keep within 30% change from baseline

Secondary

MeasureTime frame
Pain Scores at thigh preoperative period, postoperative at 0,4,8,12,24h The Numeric Rating Scale (0-10),Amount of Opioid Medications (fentanyl) Used by Patient intraoperative period Amount of opioid pain medication used by patient,Amount of nicardipine used intraoperatively intraoperative period Amount of nicardipine (in mg) used intraoperatively to decrease blood pressure after subject achieved tourniquet hypertension.,postoperative nausea and vomiting Postoperative 0,24 h The numeric rating scale,incidence of nerve injury postoperative day 0-48h incidence of nerve injury,thigh circumference preoperative and postoperative at PACU, 12 h and 24 h centimeter,postoperative dizziness postoperative 0-48h numeric rating scale,Pain Scores at surgical site preoperative period, postoperative at 0,4,8,12,24h The Numeric Rating Scale (0-10)

Countries

Thailand

Contacts

Public ContactChonruethai Tangkittithaworn

King Chulalongkorn Memorial Hospital

chonruethai.tang@gmail.com66868918491

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026