CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Fascia iliaca compartment block +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01758497
NCT01758497N/ACompleted

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

St. Luke's-Roosevelt Hospital Center·interventional·Posted Jan 1, 2013·Updated Dec 29, 2016

In Brief

A clinical study evaluating Fascia iliaca compartment block and Fascia Iliaca compartment block for Pain Disorder and Sensory Deficit. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 1, 2013
Enrollment StartOct 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.5 years ago

Interventions

Fascia iliaca compartment blockprocedure

30 ml 0.5% ropivacaine, beneath the fascia iliaca

Fascia Iliaca compartment blockprocedure

30 ml 0.9% NaCl (sham block, SB), beneath the fascia iliaca