Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty - Full Text View

Purpose

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.

Condition	Intervention
Pain, Sensory Deficit	Procedure: Fascia iliaca compartment block Procedure: Fascia Iliaca compartment block

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty; A Randomized Double Blind, Placebo-Controlled Trial

Resource links provided by NLM:

Drug Information available for: Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:

Opioid analgesic consumption [ Time Frame: 24 h postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain intensity (NRS-11) and extent of sensory blockade [ Time Frame: 24 h postoperatively ] [ Designated as safety issue: No ]
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.

Enrollment:	32
Study Start Date:	October 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Ropivacaine US guided injections of 30 ml 0.5% ropivacaine (Fascia Iliaca Compartment Block)	Procedure: Fascia iliaca compartment block 30 ml 0.5% ropivacaine, beneath the fascia iliaca Other Names: Ultrasound guided Fascia iliaca compartment block FICB
Sham Comparator: Saline US guided injections of 30 ml 0.9% NaCl (Fascia Iliaca Compartment Block)	Procedure: Fascia Iliaca compartment block 30 ml 0.9% NaCl (sham block, SB), beneath the fascia iliaca Other Names: Ultrasound guided Fascia iliaca compartment block FICB

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758497

Locations

United States, New York
St Luke's Roosevelt Hospitals
New York, New York, United States, 10025

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

Study Director:

Admir Hadzic, MD,PhD

St. Luke's-Roosevelt Hospital Center

More Information

Publications:

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.

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.

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.

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.

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.

Goitia Arrola L, Telletxea S, Martínez Bourio R, Arízaga 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. Spanish.

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.

Responsible Party:	St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT01758497 History of Changes
Other Study ID Numbers:	09-042
Study First Received:	June 6, 2012
Last Updated:	December 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Luke's-Roosevelt Hospital Center:

Fascia Iliaca compartment block, Pain, Sensorial blockade

Additional relevant MeSH terms:

Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013

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