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Status unknownNCT02056145Updated Jul 2, 2014

Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery

An interventional study of LFCNB and FNB in -Postoperative Pain, sponsored by University Hospital, Antwerp. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-02.

Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Evaluation of the combination of lateral femoral cutaneous nerve "single shot" and femoral nerve "single shot" block as effective and safe alternative postoperative analgesic technique after hip replacement surgery.

Read the detailed description

Clinical evaluation via a prospective, double-blinded, randomized clinical trial, whether ultrasound-guided single femoral block and lateral femoral cutaneous nerve blocks with 20 en 10 cc bupivacaine 0.25% respectively vs. the only ultrasound-guided single femoral block with 20 cc bupivacaine 0.25%, given just prior to elective hip surgery procedure, is effective in reducing acute postoperative pain (VAS scores) and postoperative opiate consumption.

02

Conditions studied

  • -Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 210 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Primary hip arthroplasty with posterolateral approach.

Exclusion criteria

Exclusion Criteria:

  • Known allergy to levobupivacaine and / or piritramide
  • Known neurological disorders or peripheral neuropathies
  • Existing drug or alcohol abuse
  • Chronic use of pain medication (> started 3 months ago) not related to the hip suffering
  • Coagulopathy (international normalized ratio) > 1.4
  • Thrombocytopenia \<70,000 platelets,
  • Dementia
  • Pregnancy
  • Local infection hip
  • Hepatic and / or renal impairment
  • BMI> 45.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Placebo comparator
    Group 1

    Group 1 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.9% saline solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 30 ml saline solution 0.9%.

    Procedure: LFCNB · Procedure: FNB

  • Active comparator
    Group 2

    Group 2 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.9% saline solution for lateral femoral cutaneous block, for a total of 20 cc 0.25% bupivacaine solution en 10 cc saline solution 0.9%.

    Procedure: LFCNB · Procedure: FNB

  • Active comparator
    Group 3

    Group 3 consented subjects who will receive for their hip surgery procedures general anesthesia (sevoflurane) with single shot femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 cc of 0.25% bupivacaine solution for the femoral block and 10 cc of 0.25% bupivacaine solution for lateral femoral cutaneous block, for a total of 30 cc of 0.25% bupivacaine solution.

    Procedure: LFCNB · Procedure: FNB

Interventions

  • ProcedureLFCNB

    LFCNB - Normal Saline solution 10 cc

  • ProcedureFNB

    FNB - Normal saline solution 10 cc

  • ProcedureLFCNB

    LFCNB - Chirocaine 0.25%, 20 cc

  • ProcedureFNB

    FNB - Chirocaine 0.25%, 20 cc

06

What researchers measure

Primary outcomes

  1. Use of opioids

    The primary outcome measure will be a consumption of opioids through the Intravenous Patient Controlled Analgesia pump. Those amounts will be measured en documented at the fixed intervals during the first 48 hours post-procedure.

    Time frame: 48 hours

Secondary outcomes

  1. Visual analog scale (VAS) scores (0-10)

    The secondary outcome measure will be pain scores (VAS 0-10). Those scores will be measured en documented at the fixed intervals during the first 48 hours post-procedure.

    Time frame: 48 hours

07

Study locations

1 site
  • AZ Sint Augustinus
    Wilrijk, Antwerpen 2610, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02056145
Lead sponsor
University Hospital, Antwerp
Responsible party
Ethisch Comité UZ Antwerpen (Ethische Comité UZ Antwerpen, University Hospital, Antwerp) — Principal investigator
First posted
Feb 5, 2014
Start date
Oct 2011
Primary completion
Aug 2014 (estimated)
Completion
Aug 2014 (estimated)
Last update
Jul 2, 2014

Study contacts

Sultan TEMURZIEV, MD
principal investigator · Department of Anesthesiology, Antwerp University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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