Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty

Sensory Deficit Clinical Trial

— FICB  

Official title:

Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty; A Randomized Double Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758497
• Other study ID #: 09-042
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: December 28, 2016
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: December 2016
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain Disorder
• Sensory Deficit
• Somatoform Disorders

Intervention

Procedure:
• Fascia iliaca compartment block
30 ml 0.5% ropivacaine, beneath the fascia iliaca
• Fascia Iliaca compartment block
30 ml 0.9% NaCl (sham block, SB), beneath the fascia iliaca

Locations

Country	Name	City	State
United States	St Luke's Roosevelt Hospitals	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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 — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid analgesic consumption		24 h postoperatively	No
Secondary	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.	24 h postoperatively	No