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

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.

Study Overview

• Status: Unknown
• Conditions: -Postoperative Pain
• Intervention / Treatment: Procedure: LFCNB; Procedure: FNB; Procedure: LFCNB; Procedure: FNB

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.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Wilrijk, Antwerpen, Belgium, 2610
      • AZ Sint Augustinus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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; Procedure: LFCNB; LFCNB - Chirocaine 0.25%, 20 cc; Procedure: FNB; FNB - Chirocaine 0.25%, 20 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 - Normal saline solution 10 cc; Procedure: LFCNB; LFCNB - Chirocaine 0.25%, 20 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 - Normal Saline solution 10 cc; Procedure: FNB; FNB - Normal saline solution 10 cc; Procedure: LFCNB; LFCNB - Chirocaine 0.25%, 20 cc; Procedure: FNB; FNB - Chirocaine 0.25%, 20 cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Sultan TEMURZIEV, MD, Department of Anesthesiology, Antwerp University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Estimate): July 2, 2014
• Last Update Submitted That Met QC Criteria: July 1, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 11/36/241