Comparison Between Ultrasound Guided Femoral 3 in 1 Block Versus Blind Fascia Iliaca Block Before Spinal Anaesthesia

NCT03139617 | Completed

• 1 other identifier: USM/JEPeM/15100313
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy of ultrasound guided femoral 3 in 1 block versus the blind technique single shot fascia iliaca compartment block as an analgesia method in patients prior positioning for spinal anaesthesia in femur fracture surgery. A total of 60 patients were enrolled and divided equally into 2 groups.

Conditions

Regional Anaesthesia

Keywords

Fascia Iliaca Block; Femoral 3-in-1 block; Fracture femur; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• The percentage of success rate between ultrasound guided femoral 3 in 1 block versus single shot blind fascia iliaca compartment block as analgesic method for positioning prior spinal anaesthesia in femur fracture surgery

  Using pin prick to test the sensory level at different dermatomes after given local anaesthetic following each block

  From the time of local anaesthetic injection to successful block at least 2 out of 3 dermatomes of either lateral femoral cutaneous nerve, femoral nerve or obturator nerve up to 30 minutes.

Secondary Outcomes (2)

• The onset of analgesia in term of minutes between ultrasound guided Femoral 3 in 1 nerve block versus single shot blind Fascia Iliaca Compartment Block prior positioning for spinal anaesthesia in femur fracture surgery.

  From the time of local anaesthetic given to a reduction in visual analogue pain score to less than 2 up to 30 minutes.

• The quality of blocks

  From the sitting up the patients till successful spinal anesthesia was achieved up to 10 minutes.

Study Arms (2)

Fascia Iliaca Compartment Block (FICB)

ACTIVE COMPARATOR

fascia iliaca compartment block is done using a blind technique with a blunt size 24 Gauge (G) needle. The technique is based upon the anatomical landmark and once located the space local anaesthetic ropivacaine 0.375% will be given based on the body weight.

Procedure: Fascia Iliaca Compartment Block (FICB)

3 in 1 femoral block (FNB)

EXPERIMENTAL

Ultrasound guided femoral 3 in 1 block using insulated stimulating needle 22 Gauge (G). Ropivacaine 0.375% as per ideal body weight.

Procedure: 3 in 1 femoral block (FNB)

Interventions

Fascia Iliaca Compartment Block (FICB) PROCEDURE

The FICB was done in the OT with standard monitoring with emergency airway intervention and resuscitation drug prepared before performing intended block. Patient was put in supine position, using aseptic technique, chlorhexidine solution and draped with sterile medical towel. Lignocaine 2% for local anaesthetic infiltration at punctured site.A blunted needle (Plexufix® 24G x 2", B Braun Melsungen AG 34209 Germany).A line was drawn from pubic tubercle to anterior superior iliac spine, the punctured point is 2-3cm distal to the point where medial 2/3rd and lateral 1/3rd of the line meet. Loss of resistance 2 times indicated the punctured of fascia lata and iliaca.A total volume of Ropivacaine 0.375% per body weight was given with repeated aspiration.

Fascia Iliaca Compartment Block (FICB)

3 in 1 femoral block (FNB) PROCEDURE

The FNB was done in the OT with standard monitoring with emergency airway intervention and resuscitation drug prepared before performing intended block.Patient was put in supine position, using aseptic technique, chlorhexidine solution and draped with sterile medical towel.Lignocaine 2% for local anaesthetic infiltration at punctured site.An insulated stimulating needle (Stimuplex® D Plus 22g x 2", B Braun Melsungen AG 34209 Melsungen Germany). Ultrasound was used to locate the femoral vessel and nerve and by using 'in plane' technique, the skin was punctured with the insulated needle and advance in transverse plane at around 30 angle to the skin. Local anaesthetic solution as per ideal body weight given after negative aspiration of blood .

3 in 1 femoral block (FNB)

Eligibility Criteria

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

You may qualify if:

• ASA I - III with stable hemodynamic parameters
• Planned for open reduction internal fixation of fracture femur under spinal anaesthesia

You may not qualify if:

• Coagulopathy/ Bleeding diathesis
• Known allergy to amide local anaesthetic used in the study

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

University of Science Malaysia Hospital

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (4)

• Lopez S, Gros T, Bernard N, Plasse C, Capdevila X. Fascia iliaca compartment block for femoral bone fractures in prehospital care. Reg Anesth Pain Med. 2003 May-Jun;28(3):203-7. doi: 10.1053/rapm.2003.50134.

  PMID: 12772137 RESULT

• Capdevila X, Biboulet P, Bouregba M, Barthelet Y, Rubenovitch J, d'Athis F. Comparison of the three-in-one and fascia iliaca compartment blocks in adults: clinical and radiographic analysis. Anesth Analg. 1998 May;86(5):1039-44. doi: 10.1097/00000539-199805000-00025.

  PMID: 9585293 RESULT

• Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available.

  PMID: 4796576 RESULT

• Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13.

  PMID: 2589650 RESULT

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Rhendra Hardy Mohamad Zaini, MD

  Universiti of Science Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 15, 2017
• First Posted: May 4, 2017
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)