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

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02056145
• Other study ID #: 11/36/241
• Status: Active, not recruiting
• Phase: N/A
• First received: February 4, 2014
• Last updated: July 1, 2014
• Start date: October 2011
• Est. completion date: August 2014

Study information

• Verified date: July 2014
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• LFCNB
LFCNB - Normal Saline solution 10 cc
• FNB
FNB - Normal saline solution 10 cc
• LFCNB
LFCNB - Chirocaine 0.25%, 20 cc
• FNB
FNB - Chirocaine 0.25%, 20 cc

Locations

Country	Name	City	State
Belgium	AZ Sint Augustinus	Wilrijk	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes