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

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ClinicalTrials.gov Identifier: NCT02056145
Recruitment Status : Unknown
Verified July 2014 by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp.
Recruitment status was:  Active, not recruiting
First Posted : February 5, 2014
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp

Brief 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.

Condition or disease Intervention/treatment Phase
-Postoperative Pain Procedure: LFCNB Procedure: FNB Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2011
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Arm Intervention/treatment
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
LFCNB - Normal Saline solution 10 cc

Procedure: FNB
FNB - Normal saline solution 10 cc

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
LFCNB - Normal Saline solution 10 cc

Procedure: FNB
FNB - Chirocaine 0.25%, 20 cc

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
LFCNB - Chirocaine 0.25%, 20 cc

Procedure: FNB
FNB - Chirocaine 0.25%, 20 cc




Primary Outcome Measures :
  1. Use of opioids [ Time Frame: 48 hours ]
    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.


Secondary Outcome Measures :
  1. Visual analog scale (VAS) scores (0-10) [ Time Frame: 48 hours ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary hip arthroplasty with posterolateral approach.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056145


Locations
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Belgium
AZ Sint Augustinus
Wilrijk, Antwerpen, Belgium, 2610
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Sultan TEMURZIEV, MD Department of Anesthesiology, Antwerp University Hospital
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Responsible Party: Ethisch Comité UZ Antwerpen, Ethische Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02056145    
Other Study ID Numbers: 11/36/241
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations