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

Antwerp University Hospital (UZA)

Status: Unknown

Conditions: -Postoperative Pain

Treatments: Procedure: LFCNB; Procedure: FNB

Study type: Interventional

Funder types: Other

Identifiers

NCT02056145

11/36/241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

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%.

Treatment:

Procedure: LFCNB

Procedure: LFCNB

Procedure: FNB

Procedure: FNB

Group 2

Active Comparator group

Description:

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%.

Treatment:

Procedure: LFCNB

Procedure: LFCNB

Procedure: FNB

Procedure: FNB

Group 3

Active Comparator group

Description:

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.

Treatment:

Procedure: LFCNB

Procedure: LFCNB

Procedure: FNB

Procedure: FNB