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Comparison of low dose spinal anaesthesia and nerve blocks for below knee amputation surgery in patients with diabetic foot infections

Comparison of Low Dose Subarachnoid Block vs. Ultrasound Guided Femoral-Popliteal Sciatic Block in Diabetic Patients undergoing Emergency Below Knee amputation for Diabetic Foot Infections: A Randomized Non Inferiority Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022700
Enrollment
56
Registered
2020-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Low Dose Subarachnoid block (Spinal anaesthesia): Patients randomised to this group will receive 1ml of 0.5% hyperbaric bupivacaine (5 mg) and 0.5 ml of 25 μg fentanyl (total volume of

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with diabetic foot infection posted for Emergency below knee amputation surgery

Exclusion criteria

Exclusion criteria: Patients who are in vasopressor/inotropic support. Patients who are in coagulopathy (INR > 1.5 or platelet Patients with Systolic BP less than 80 mm Hg. Patients who are unable to cooperate for the procedure. Local infection at procedural site. Patients who are allergic to local anesthetics

Design outcomes

Primary

MeasureTime frame
Comparison of percentage decrease in systolic blood pressure (SBP) from the baseline between the two groups (Group low dose subarachnoid block and Group femoral-popliteal block)Timepoint: Baseline, every two minutes for first 10 minutes after intervention and every 5 minutes till the end of surgery

Secondary

MeasureTime frame
Comparison of mean intra-operative fluid used between the groupsTimepoint: From the intervention to the end of surgery, amount of intravenous fluid administered will be documented;Comparison of mean vasopressor use intra-operatively (to maintain a minimum MAP of 65 mm-Hg) between the groups. Timepoint: From the intervention to the end of surgery, requirement of vasopressor will be documented;Comparison of pH, pCO2, lactate and bicarbonate between the groupsTimepoint: Before the intervention and at the end of surgery

Countries

India

Contacts

Public ContactMuthapillai Senthilnathan

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

mmc.senthil@gmail.com7598566983

Outcome results

None listed

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