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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Subarachnoid Block; Femoropopliteal Block; Tissue Oxygen Saturation
• Interventions: Drug: Mixture of local anesthetics; Drug: 0.5% hyperbaric bupivacaine

• Registration Number: NCT06702202
• Lead Sponsor: Indonesia University

Brief Summary

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.

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 Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoropopliteal block (Group F)	Mixture of local anesthetics	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
Subarachnoid block (Group S)	0.5% hyperbaric bupivacaine	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

Primary Outcome Measures

Name	Time	Method
Measurement of Tissue Oxygen Saturation (StO2)	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	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.

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia