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Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

Primary Purpose

Chronic Lower Limb Ischemia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fascia iliaca block (FIB)
Spinal anesthesia
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Lower Limb Ischemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I or II.

Exclusion Criteria:

  • Patients with previous same lower limb surgery
  • Neuromuscular disease
  • Severe cardiovascular disease
  • Any contraindications to regional anesthesia
  • patient refusal
  • coagulation abnormality
  • Known allergy to local anesthetics
  • Infection at the injection site

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fascia iliaca block (FIB)

Spinal anesthesia

Arm Description

ultrasound-guided Fascia iliaca block

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Outcomes

Primary Outcome Measures

The proportion of the patients who did not require conversion to general anesthesia

Secondary Outcome Measures

Postoperative pain
The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)
Heart rate
changes in Heart rate
mean arterial pressure (MAP
changes in mean arterial pressure (MAP
hypotension
Incidents of hypotension
Any observed adverse effects
ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding
bradycardia
Incidents if bradycardia

Full Information

First Posted
January 8, 2019
Last Updated
September 19, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03798834
Brief Title
Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy
Official Title
Fascia Iliaca Block as an Anesthetic Technique for Thromboembolectomy of Chronic Lower Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 17, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus. The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.
Detailed Description
This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lower Limb Ischemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fascia iliaca block (FIB)
Arm Type
Experimental
Arm Description
ultrasound-guided Fascia iliaca block
Arm Title
Spinal anesthesia
Arm Type
Placebo Comparator
Arm Description
Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Fascia iliaca block (FIB)
Intervention Description
ultrasound-guided Fascia iliaca block
Intervention Type
Other
Intervention Name(s)
Spinal anesthesia
Intervention Description
Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%
Primary Outcome Measure Information:
Title
The proportion of the patients who did not require conversion to general anesthesia
Time Frame
for 30 minutes
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)
Time Frame
For 24 hours after the intervention
Title
Heart rate
Description
changes in Heart rate
Time Frame
For 6 hours after the intervention
Title
mean arterial pressure (MAP
Description
changes in mean arterial pressure (MAP
Time Frame
For 6 hours after the intervention
Title
hypotension
Description
Incidents of hypotension
Time Frame
For 24 hours from the block
Title
Any observed adverse effects
Description
ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding
Time Frame
over the 24 hours postoperative
Title
bradycardia
Description
Incidents if bradycardia
Time Frame
For 24 hours from the block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I or II. Exclusion Criteria: Patients with previous same lower limb surgery Neuromuscular disease Severe cardiovascular disease Any contraindications to regional anesthesia patient refusal coagulation abnormality Known allergy to local anesthetics Infection at the injection site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem A Elsharkawy, MD
Organizational Affiliation
Lecturer of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University
City
Mansourah
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

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