Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

NCT02696915 | Completed DMC

• 1 other identifier: MS/811
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Fracture femur is a common injury which is associated with excruciating pain. Positioning for neuraxial blocks is always challenging because even slight overriding of the fracture ends is intensely painful .It can causing major patient distress which accompanied by well-known physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and increased cardiac work that may compromise high-risk cardiac patients. Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but it is also associated with minimal risk as the local anesthetic is injected at a safe distance from the femoral artery and femoral nerve. It is always safe to perform the fascia iliaca compartment block prior to spinal anesthesia as the patient can respond during administration of the local anesthetic and can prevent intra-neuronal injections

Conditions

Proximal Femur Fractures

Outcome Measures

Primary Outcomes (1)

• Pain scores

  Pain was assessed using visual analogue score

  For 24 hours after performance the blockade

Secondary Outcomes (9)

• Heart rate

  For 24 hours after performance the blockade

• Blood pressure

  For 24 hours after performance the blockade

• Peripheral oxygen saturation

  For 24 hours after performance the blockade

• Time to performing spinal anesthesia

  For 30 min after placement of patient in the optimum position

• Number of trials of dural puncture

  For 30 min after placement of patient in the optimum position

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.

Drug: Placebo; Device: Ultrasound guided fascia iliaca compartment block; Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)

Bupivacaine

ACTIVE COMPARATOR

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.

Drug: Bupivacaine; Device: Ultrasound guided fascia iliaca compartment block; Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)

Interventions

Placebo DRUG

Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml

Placebo

Bupivacaine DRUG

Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml

Bupivacaine

Ultrasound guided fascia iliaca compartment block DEVICE

Ultrasound guided fascia iliaca compartment block

Bupivacaine; Placebo

Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms) DRUG

Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms

Bupivacaine; Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist physical status I to III
• Patients scheduled for fixation for proximal end femur fracture

You may not qualify if:

• Patients refusal
• Morbid obese patients (BMI\>40)
• Bleeding diathesis
• Previous femoral bypass surgery
• Inguinal hernia
• Inflammation/infection over injection site
• Peripheral neuropathy
• Allergy to local anesthetics agents used.
• Severely altered consciousness level
• Psychiatric disorders
• Polytrauma

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

Related Publications (1)

• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Proximal Femoral Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Reem A El Sharkawy, MD

  Lecturer of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 2, 2016
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

EG (1)