Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

NCT03798834 | Completed DMC

• 1 other identifier: R/17.07.111
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lower Limb Ischemia

Outcome Measures

Primary Outcomes (1)

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

  for 30 minutes

Secondary Outcomes (6)

• Postoperative pain

  For 24 hours after the intervention

• Heart rate

  For 6 hours after the intervention

• mean arterial pressure (MAP

  For 6 hours after the intervention

• hypotension

  For 24 hours from the block

• Any observed adverse effects

  over the 24 hours postoperative

Study Arms (2)

Fascia iliaca block (FIB)

EXPERIMENTAL

ultrasound-guided Fascia iliaca block

Drug: Fascia iliaca block (FIB)

Spinal anesthesia

PLACEBO COMPARATOR

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Other: Spinal anesthesia

Interventions

Fascia iliaca block (FIB) DRUG

ultrasound-guided Fascia iliaca block

Fascia iliaca block (FIB)

Spinal anesthesia OTHER

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Reem A Elsharkawy, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: November 17, 2018
• Primary Completion: February 1, 2019
• Study Completion: April 15, 2019
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

EG (1)