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

NCT ID: NCT06702202

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-07-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Mixture of local anesthetics

Intervention Type: DRUG

Marcaine® (bupivacaine HCl) 0,5% and Xylocaine® (Lidocaine HCL) 2% = 2:1 Given in Femoropopliteal block group (Group F)

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

Group Type: EXPERIMENTAL

0.5% hyperbaric bupivacaine

Intervention Type: DRUG

Given in Subarachnoid block group (Group S)

Interventions

Mixture of local anesthetics

Marcaine® (bupivacaine HCl) 0,5% and Xylocaine® (Lidocaine HCL) 2% = 2:1 Given in Femoropopliteal block group (Group F)

Intervention Type: DRUG

0.5% hyperbaric bupivacaine

Given in Subarachnoid block group (Group S)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Aida Rosita Tantri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

IndonesiaUAnes141124

Identifier Type: -

Identifier Source: org_study_id