Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty

NCT01758497 | Completed DMC

• 1 other identifier: 09-042
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Disorder; Sensory Deficit

Keywords

Fascia Iliaca compartment block, Pain, Sensorial blockade

Outcome Measures

Primary Outcomes (1)

• Opioid analgesic consumption

  24 h postoperatively

Secondary Outcomes (1)

• Pain intensity (NRS-11) and extent of sensory blockade

  24 h postoperatively

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

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

Procedure: Fascia iliaca compartment block

Saline

SHAM COMPARATOR

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

Procedure: Fascia Iliaca compartment block

Interventions

Fascia Iliaca compartment block PROCEDURE

30 ml 0.5% ropivacaine, beneath the fascia iliaca

Also known as: Ultrasound guided Fascia iliaca compartment block, FICB

Ropivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St Luke's Roosevelt Hospitals

New York, New York, 10025, United States

Location

Related Publications (7)

• 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.

  PMID: 2589650 RESULT

• 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.

  PMID: 19258967 RESULT

• 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.

  PMID: 19749590 RESULT

• 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.

  PMID: 17413915 RESULT

• 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.

  PMID: 18084988 RESULT

• 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.

  PMID: 19725341 RESULT

• 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.

  PMID: 15029544 RESULT

MeSH Terms

Conditions

Somatoform Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Admir Hadzic, MD,PhD

  St. Luke's-Roosevelt Hospital Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: January 1, 2013
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (1)