An interventional study of Fascia iliaca compartment block and Fascia Iliaca compartment block in Pain Disorder and Sensory Deficit, sponsored by St. Luke's-Roosevelt Hospital Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by St. Luke's-Roosevelt Hospital Center · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 32 is below the median of 57 across 316 interventional studies indexed under Somatoform Disorders.
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Exclusion Criteria:
US guided injections of 30 ml 0.5% ropivacaine (Fascia Iliaca Compartment Block)
Procedure: Fascia iliaca compartment block
US guided injections of 30 ml 0.9% NaCl (Fascia Iliaca Compartment Block)
Procedure: Fascia Iliaca compartment block
30 ml 0.5% ropivacaine, beneath the fascia iliaca
Also known as: Ultrasound guided Fascia iliaca compartment block, FICB
30 ml 0.9% NaCl (sham block, SB), beneath the fascia iliaca
Also known as: Ultrasound guided Fascia iliaca compartment block, FICB
Opioid analgesic consumption
Time frame: 24 h postoperatively
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.
Time frame: 24 h postoperatively
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St. Luke's-Roosevelt Hospital Center