Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Pain Disorder; Sensory Deficit
• Interventions: Procedure: Fascia Iliaca compartment block

• Registration Number: NCT01758497
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-12-24
• Study First Posted: 2013-01-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Fascia Iliaca compartment block	US guided injections of 30 ml 0.5% ropivacaine (Fascia Iliaca Compartment Block)
Saline	Fascia Iliaca compartment block	US guided injections of 30 ml 0.9% NaCl (Fascia Iliaca Compartment Block)

Primary Outcome Measures

Name	Time	Method
Opioid analgesic consumption	24 h postoperatively

Secondary Outcome Measures

Name	Time	Method
Pain intensity (NRS-11) and extent of sensory blockade	24 h postoperatively	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.

Trial Locations

Locations (1)

St Luke's Roosevelt Hospitals; 🇺🇸 New York, New York, United States