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

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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