Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy

NCT06745986 | Completed Phase 4 FDA Drug

• 1 other identifier: MS/17.10.109
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the efficiency of Fascia Iliaca Compartmental Block in patients undergoing femoral thrombectomy versus spinal anesthesia.

Conditions

Fascia Iliaca Compartmental Block; Femoral Thrombectomy; Spinal Anesthesia

Keywords

Visual Analogue Score; UltraSound Guided; Fascia Iliaca Compartmental Block,; Spinal Anesthesia,; Femoral Thrombectomy

Outcome Measures

Primary Outcomes (1)

• pain score postoperative

  visual analogue score (VAS), with a scale from 0 to 10

  24 hours

Study Arms (2)

Fascia iliaca group

ACTIVE COMPARATOR

The ultrasound-guided fascia iliaca compartment block (FICB) group included 42 patients who had a fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml.

Drug: ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% )

spinal anesthesia

ACTIVE COMPARATOR

spinal anesthesia included 42 patients had spinal anesthesia with 2.5 ml bupivacaine 0.5%.

Drug: Spinal Anesthesia (bupivacaine)

Interventions

ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% ) DRUG

Fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml.

Fascia iliaca group

Spinal Anesthesia (bupivacaine) DRUG

spinal anesthesia by 2.5 ml bupivacaine 0.5%

spinal anesthesia

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• scheduled femoral thrombectomy,
• both sexes,
• aged between 40-65 years,
• American Society of Anesthesiologists (ASA) II-III. Patients Criteria:

You may not qualify if:

• ASA status Grade IV, patient
• refused to participate,
• patients with contraindications to neuraxial anesthesia, such as systemic infection or history of allergy to anesthetic drugs
• infection at the site of injection.

Sponsors & Collaborators

• Port Said University hospital: lead

Study Sites (1)

Mansoura university hosbital

New Damietta, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Spinal; Bupivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesiai ntensivecare and pain managment

Model Details: Eighty-four cases were scheduled for femoral thrombectomy and classified into tw0 equal groups (n=42 each), spinal group received spinal anesthesia with 0.5% hyperbaric bupivacaine in a total volume in a total volume 2.5ml and fascia iliaca group received ultrasound guided fascia iliaca block with 40ml of 0.25% bupivacaine for each block. Data collected for each block were onset and duration of sensory and motor block, visual analogue scale, analgesic duration and analgesic consumption, hemodynamics and complications.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: December 13, 2017
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be made available upon publication of the study results in a peer-reviewed journal.
• Access Criteria: Researchers and healthcare professionals conducting methodologically sound and ethically approved research

Locations

EG (1)