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Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty (FICB)

Primary Purpose

Pain Disorder, Sensory Deficit

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fascia iliaca compartment block
Fascia Iliaca compartment block
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Disorder focused on measuring Fascia Iliaca compartment block, Pain, Sensorial blockade

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults
  • ASA physical status I-III
  • BMI<30
  • No contraindications to study procedures

Exclusion Criteria:

  • Pediatric patients
  • ASA physical status IV
  • BMI>30
  • Contraindications to study procedures
  • Hypersensitivity to local anesthetics

Sites / Locations

  • St Luke's Roosevelt Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ropivacaine

Saline

Arm Description

US guided injections of 30 ml 0.5% ropivacaine (Fascia Iliaca Compartment Block)

US guided injections of 30 ml 0.9% NaCl (Fascia Iliaca Compartment Block)

Outcomes

Primary Outcome Measures

Opioid analgesic consumption

Secondary Outcome Measures

Pain intensity (NRS-11) and extent of sensory blockade
Pain intensity was assessed immediately before and after block placement and at 10-min intervals for the first 30 min after block. Sensory assessment was at 30 min after block, using a pinprick test in the lateral, medial and anterior aspects of the thigh. Specifically, sensation in the territories of the lateral femoral cutaneous, obturator, and femoral nerves was tested using a scale of 0-2 ( 0 = no sensation, 1 = diminished sensation, 2= full sensation). Assessment of motor blockade was not possible because of lower extremity immobilization after surgery to prevent hip dislocation.

Full Information

First Posted
June 6, 2012
Last Updated
December 28, 2016
Sponsor
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01758497
Brief Title
Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty
Acronym
FICB
Official Title
Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty; A Randomized Double Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Introduction Fascia Iliaca compartment block (FICB) is commonly used to treat pain in patients after total hip arthroplasty (THA) despite the lack of RCTs to evaluate the efficacy of FICB for this indication. Therefore the objective of this study was to assess the analgesic benefit of FICB for post-operative pain management in THA. Methods After IRB approval and informed consent, patients having THA at our center in the period 2010-2011 were recruited. Eligible patients were adults, ASA physical status I-III, and BMI <30) with no contraindication to study procedures. In the PACU, all patients received morphine sulfate IVPCA; patients reporting pain > 3 on the NRS-11 despite IVPCA were randomized by the method of sealed envelopes to receive US guided injections of 30ml 0.5% ropivacaine (FICB) or 30ml 0.9% NaCl (sham block, SB) beneath the fascia iliaca. The primary outcome variable was opioid analgesic consumption during the first 24 h postoperatively. Secondary outcome measures were pain intensity (NRS-11) and extent of sensory blockade.
Detailed Description
Introduction Fascia Iliaca compartment block (FICB) is commonly used to treat pain in patients after total hip arthroplasty (THA) despite the lack of RCTs to evaluate the efficacy of FICB for this indication. Therefore the objective of this randomized, prospective trial was to assess the analgesic benefit of FICB for post-operative pain management in THA. Our hypothesis was that FICB would confer an analgesic benefit for patients after THA. Methods After IRB approval and informed consent, patients having THA at our center in the period 2010-2011 were recruited in the morning of their surgery. Eligible patients were adults, ASA physical status I-III, and BMI <30) with no contraindication to study procedures. In the PACU, all patients received morphine sulfate IVPCA; patients reporting pain > 3 on the NRS-11 despite IVPCA were randomized by the method of sealed envelopes to receive US guided injections of 30ml 0.5% ropivacaine (FICB) or 30ml 0.9% NaCl (sham block, SB) beneath the fascia iliaca. The primary outcome variable was opioid analgesic consumption during the first 24 h postoperatively. Secondary outcome measures were pain intensity (NRS-11) and extent of sensory blockade.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Disorder, Sensory Deficit
Keywords
Fascia Iliaca compartment block, Pain, Sensorial blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
US guided injections of 30 ml 0.5% ropivacaine (Fascia Iliaca Compartment Block)
Arm Title
Saline
Arm Type
Sham Comparator
Arm Description
US guided injections of 30 ml 0.9% NaCl (Fascia Iliaca Compartment Block)
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment block
Other Intervention Name(s)
Ultrasound guided Fascia iliaca compartment block, FICB
Intervention Description
30 ml 0.5% ropivacaine, beneath the fascia iliaca
Intervention Type
Procedure
Intervention Name(s)
Fascia Iliaca compartment block
Other Intervention Name(s)
Ultrasound guided Fascia iliaca compartment block, FICB
Intervention Description
30 ml 0.9% NaCl (sham block, SB), beneath the fascia iliaca
Primary Outcome Measure Information:
Title
Opioid analgesic consumption
Time Frame
24 h postoperatively
Secondary Outcome Measure Information:
Title
Pain intensity (NRS-11) and extent of sensory blockade
Description
Pain intensity was assessed immediately before and after block placement and at 10-min intervals for the first 30 min after block. Sensory assessment was at 30 min after block, using a pinprick test in the lateral, medial and anterior aspects of the thigh. Specifically, sensation in the territories of the lateral femoral cutaneous, obturator, and femoral nerves was tested using a scale of 0-2 ( 0 = no sensation, 1 = diminished sensation, 2= full sensation). Assessment of motor blockade was not possible because of lower extremity immobilization after surgery to prevent hip dislocation.
Time Frame
24 h postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults ASA physical status I-III BMI<30 No contraindications to study procedures Exclusion Criteria: Pediatric patients ASA physical status IV BMI>30 Contraindications to study procedures Hypersensitivity to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Admir Hadzic, MD,PhD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Study Director
Facility Information:
Facility Name
St Luke's Roosevelt Hospitals
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2589650
Citation
Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13. Erratum In: Anesth Analg 1990 Apr;70(4):474.
Results Reference
result
PubMed Identifier
19258967
Citation
Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31. doi: 10.1016/j.rapm.2008.03.008.
Results Reference
result
PubMed Identifier
19749590
Citation
Weller RS. Does fascia iliaca block result in obturator block? Reg Anesth Pain Med. 2009 Sep-Oct;34(5):524; author reply 524. doi: 10.1097/AAP.0b013e3181ada59f. No abstract available.
Results Reference
result
PubMed Identifier
17413915
Citation
Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.
Results Reference
result
PubMed Identifier
18084988
Citation
Stevens M, Harrison G, McGrail M. A modified fascia iliaca compartment block has significant morphine-sparing effect after total hip arthroplasty. Anaesth Intensive Care. 2007 Dec;35(6):949-52. doi: 10.1177/0310057X0703500615.
Results Reference
result
PubMed Identifier
19725341
Citation
Goitia Arrola L, Telletxea S, Martinez Bourio R, Arizaga Maguregui A, Aguirre Larracoechea U. [Fascia iliaca compartment block for analgesia following total hip replacement surgery]. Rev Esp Anestesiol Reanim. 2009 Jun-Jul;56(6):343-8. doi: 10.1016/s0034-9356(09)70406-2. Spanish.
Results Reference
result
PubMed Identifier
15029544
Citation
Biboulet P, Morau D, Aubas P, Bringuier-Branchereau S, Capdevila X. Postoperative analgesia after total-hip arthroplasty: Comparison of intravenous patient-controlled analgesia with morphine and single injection of femoral nerve or psoas compartment block. a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2004 Mar-Apr;29(2):102-9. doi: 10.1016/j.rapm.2003.11.006.
Results Reference
result

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Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty

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