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

University of Indonesia (UI)

Status: Completed

Conditions: Peripheral Arterial Disease; Tissue Oxygen Saturation; Subarachnoid Block; Femoropopliteal Block

Treatments: Drug: 0.5% hyperbaric bupivacaine; Drug: Mixture of local anesthetics

Study type: Interventional

Funder types: Other

Identifiers

NCT06702202

IndonesiaUAnes141124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Femoropopliteal block (Group F)

Experimental group

Description:

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

Treatment:

Drug: Mixture of local anesthetics

Subarachnoid block (Group S)

Experimental group

Description:

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

Treatment:

Drug: 0.5% hyperbaric bupivacaine