Pain DisorderFICBNCT01758497
Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty
A study testing Fascia iliaca compartment block in people with Pain Disorder and Sensory Deficit, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Disorder, Sensory Deficit
- What is being tested?
- Fascia iliaca compartment block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults
- ASA physical status I-III
- BMI<30
- No contraindications to study procedures
Who cannot join
- Pediatric patients
- ASA physical status IV
- BMI>30
- Contraindications to study procedures
- Hypersensitivity to local anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
St Luke's Roosevelt Hospitals
New York, New York, 10025
About this study
Official title: Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty; A Randomized Double Blind, Placebo-Controlled Trial
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.
Read the 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.
- Conditions
- Pain Disorder, Sensory Deficit
- Being tested
- Fascia iliaca compartment block
- Keywords
- Fascia Iliaca compartment block, Pain, Sensorial blockade
- Medical subject headings
- Somatoform Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca compartment blockProcedure or surgery
Also called Ultrasound guided Fascia iliaca compartment block, FICB
30 ml 0.5% ropivacaine, beneath the fascia iliaca
Fascia Iliaca compartment blockProcedure or surgery
Also called Ultrasound guided Fascia iliaca compartment block, FICB
30 ml 0.9% NaCl (sham block, SB), beneath the fascia iliaca
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | US guided injections of 30 ml 0.5% ropivacaine (Fascia Iliaca Compartment Block) Receives: Procedure: Fascia iliaca compartment block |
| Saline | Sham comparator | US guided injections of 30 ml 0.9% NaCl (Fascia Iliaca Compartment Block) Receives: Procedure: Fascia Iliaca compartment block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid analgesic consumption
Measured: 24 h postoperatively
Secondary outcomes (1)
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.
Measured: 24 h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Admir Hadzic, MD,PhD, Study director, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758497
- Sponsor's protocol ID
- 09-042
- Acronym
- FICB
- Status last verified
- Dec 2016
- First submitted
- 6 Jun 2012
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 2589650Dolan 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.
PubMed 19258967Weller 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.
PubMed 19749590Foss 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.
PubMed 17413915Stevens 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.
PubMed 18084988Goitia 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.
PubMed 19725341Biboulet 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.
PubMed 15029544
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Compartment Block For Analgesia After Total Hip Arthroplasty; A Randomized Double Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01758497
- Acronym / sponsor ID
- FICB / 09-042
- Conditions
- Pain Disorder, Sensory Deficit
- Keywords
- Fascia Iliaca compartment block, Pain, Sensorial blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Procedure: Fascia iliaca compartment blockUS guided injections of 30 ml 0.5% ropivacaine (Fascia Iliaca Compartment Block) |
| Saline | Sham comparator | Procedure: Fascia Iliaca compartment blockUS guided injections of 30 ml 0.9% NaCl (Fascia Iliaca Compartment Block) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults
- ASA physical status I-III
- BMI<30
- No contraindications to study procedures
Key exclusion criteria (5 listed)
- Pediatric patients
- ASA physical status IV
- BMI>30
- Contraindications to study procedures
- Hypersensitivity to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascia iliaca compartment blockAlso: Ultrasound guided Fascia iliaca compartment block, FICB30 ml 0.5% ropivacaine, beneath the fascia iliaca | Procedure or surgery | Ropivacaine |
| Fascia Iliaca compartment blockAlso: Ultrasound guided Fascia iliaca compartment block, FICB30 ml 0.9% NaCl (sham block, SB), beneath the fascia iliaca | Procedure or surgery | Saline |
Primary outcome
Opioid analgesic consumption
Time frame: 24 h postoperatively
1 secondary outcome
Pain intensity (NRS-11) and extent of sensory blockade
Time frame: 24 h postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Results publication: PubMed 2589650Dalens 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.
- Results publication: PubMed 19258967Dolan 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.
- Results publication: PubMed 19749590Weller 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.
- Results publication: PubMed 17413915Foss 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.
- Results publication: PubMed 18084988Stevens 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.
- Results publication: PubMed 19725341Goitia 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.
- Results publication: PubMed 15029544Biboulet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Admir Hadzic, MD,PhD study director
St. Luke's-Roosevelt Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia iliaca compartment block in people with Pain Disorder and Sensory Deficit, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid analgesic consumption (time frame: 24 h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758497, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.