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

Not Applicable

• Conditions: -Postoperative Pain
• Interventions: Procedure: LFCNB; Procedure: FNB

• Registration Number: NCT02056145
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-02
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2	FNB	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%.
Group 2	LFCNB	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%.
Group 3	LFCNB	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.
Group 1	LFCNB	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%.
Group 1	FNB	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%.
Group 3	FNB	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.

Primary Outcome Measures

Name	Time	Method
Use of opioids	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

Name	Time	Method
Visual analog scale (VAS) scores (0-10)	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.

Trial Locations

Locations (1)

AZ Sint Augustinus; 🇧🇪 Wilrijk, Antwerpen, Belgium