Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in PAD Patients

Comparison of the Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in Patients with Peripheral Arterial Disease

This pilot study investigates the effects of femoropopliteal and subarachnoid nerve blocks on tissue oxygen saturation (StO2) in patients with Peripheral Arterial Disease (PAD) during lower limb surgeries. Using Near-Infrared Spectroscopy (NIRS), the study compares changes in StO2 post-block. Although no significant differences were found between the two block types at most time points, subarachnoid blocks generally led to higher StO2 increases compared to femoropopliteal blocks, with significant differences observed at 5 and 15 minutes post-block.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Subarachnoid Block; Tissue Oxygen Saturation; Femoropopliteal Block
• Intervention / Treatment: Drug: Mixture of local anesthetics; Drug: 0.5% hyperbaric bupivacaine

Detailed Description

This pilot study explored the impact of femoropopliteal and subarachnoid nerve blocks on tissue oxygen saturation (StO2) in patients with Peripheral Arterial Disease (PAD) during lower limb surgeries, using Near-Infrared Spectroscopy (NIRS) for non-invasive monitoring. The study compared StO2 changes at baseline, 5, 15, and 30 minutes post-block in two groups: those receiving femoropopliteal blocks and those receiving subarachnoid blocks.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Cental National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80 years old who are scheduled to undergo lower limb debridement surgery.
• Diagnosis of Peripheral Arterial Disease (PAD).
• Lesion located below the knee.

Exclusion Criteria:

• Consuming opioids before hospital admission.
• Having allergies to the medications used in the study.
• Presence of infection at the injection site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Femoropopliteal block (Group F); Ultrasonography was performed using the Mindray DP-10 system with a linear transducer positioned at the inguinal fold to identify and visualize the femoral nerve, 10 ml mixture of local anesthetics ( Marcaine® [bupivacaine HCl] 0,5% and Xylocaine® [Lidocaine HCL] 2% = 2:1) were injected in-plane around the femoral nerve. For popliteal sciatic nerve blocks, linear transducer was placed transversally on the distal thigh to visualize Sciatic nerve just before branching, followed by the injection of 20 ml of the same mixture of local anesthetics through a 50 mm block needle in-plane	Drug: Mixture of local anesthetics; Marcaine® (bupivacaine HCl) 0,5% and Xylocaine® (Lidocaine HCL) 2% = 2:1 Given in Femoropopliteal block group (Group F)
Experimental: Subarachnoid block (Group S); Patients may assume either a sitting or lateral decubitus position, and subsequent to aseptic procedures, a G27 spinal needle will be introduced into the L3-4 interspinous space until clear cerebrospinal fluid visualization, followed by the injection of 2-2.5 ml of 0.5% hyperbaric Bupivacaine	Drug: 0.5% hyperbaric bupivacaine; Given in Subarachnoid block group (Group S)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Tissue Oxygen Saturation (StO2)	The primary outcome of this study is the percentage increase in tissue oxygen saturation (StO2) following the administration of femoropopliteal nerve blocks and spinal anesthesia. StO2 will be measured at two locations below the knee (Points A and B) at different heights. Measurements will be taken at four time points: 10 minutes before the intervention (TI), and 5, 15, and 30 minutes after the intervention (T2, T3, T4). The goal is to assess and compare the changes in StO2 induced by each type of anesthesia.	TI (Baseline): 10 minutes before the intervention; T2: 5 minutes after the intervention; T3: 15 minutes after the intervention; T4: 30 minutes after the intervention

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Bupivacaine; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: IndonesiaUAnes141124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No