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

Primary Purpose

-Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
LFCNB
FNB
LFCNB
FNB
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for -Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • AZ Sint Augustinus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm 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%.

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 4, 2014
Last Updated
July 1, 2014
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT02056145
Brief Title
Ultrasound Guided Lateral Femoral Cutaneous Block (LFCNB) And Femoral Nerve Block (FNB) For Postoperative Pain Control After Hip Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
-Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm 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%.
Arm Title
Group 2
Arm Type
Active Comparator
Arm 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%.
Arm Title
Group 3
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
LFCNB
Intervention Description
LFCNB - Normal Saline solution 10 cc
Intervention Type
Procedure
Intervention Name(s)
FNB
Intervention Description
FNB - Normal saline solution 10 cc
Intervention Type
Procedure
Intervention Name(s)
LFCNB
Intervention Description
LFCNB - Chirocaine 0.25%, 20 cc
Intervention Type
Procedure
Intervention Name(s)
FNB
Intervention Description
FNB - Chirocaine 0.25%, 20 cc
Primary Outcome Measure Information:
Title
Use of opioids
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) scores (0-10)
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sultan TEMURZIEV, MD
Organizational Affiliation
Department of Anesthesiology, Antwerp University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint Augustinus
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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