Osteoarthritis of the HipPhase 4NCT02299271
Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty
A Phase 4 study testing Ropivacaine and Saline in people with Osteoarthritis of the Hip, run by The Christ Hospital at 1 site in United States.
Trial summary
This study evaluates post-operative pain management and narcotic consumption in patients receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca block with saline for total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Hip
- What is being tested?
- Ropivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2016
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- anterior approach total hip arthroplasty (THA) for unilateral osteoarthritis
- English-speaking
- age 18 to 75 years
- American Society of Anesthesiologists (ASA) physical status 1 to 3
- BMI < 40 kg/m2
- Minimum weight of 50 kg.
- No contraindications to study procedures
Who cannot join
- Hip revision surgery
- Allergy to local anesthetics
- Allergy to oxycontin
- Allergy to pregabalin
- Allergy to fentanyl
- Allergy to midazolam
Show all 9Show fewer
- Allergy to hydromorphone
- BMI > 40 kg/m2
- Chronic pre-operative opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
This study evaluates post-operative pain management and narcotic consumption in patients receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca block with saline for total hip arthroplasty.
Read the detailed description
Although many improvements have been made in implant technology and surgical approaches for total hip arthroplasty, management of post-operative pain remains a major clinical issue. Inadequate pain control can lead to numerous unwanted side effects and limited physical function, especially in a older population. Most surgeons have adopted a multi-modality pain management approach using a variety of pharmaceuticals, including nerve block with local anesthetic. In the literature, there are a number of technical variations described for the fascia iliaca nerve block. At The Christ Hospital, Cincinnati, Ohio, anesthesiologists use a more proximal approach to the fasica iliaca block enabling a significantly easier cephalad spread of the local anesthetic into the pelvis targeting all three nerves; the femoral, lateral femoral cutaneous, and the obturator.
This prospective, double-blinded, randomized, single-center study is designed to test the primary hypothesis that fascia iliaca block with a local anesthestic decreases narcotic consumption and provides improved pain control compared to placebo in the first 24 hours after surgery in patients undergoing total hip arthroplasty.
- Conditions
- Osteoarthritis of the Hip
- Being tested
- Ropivacaine, Saline
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
0.375% ropivacaine as a one-time, 60 milliliter injection
SalineDrug
Also called Sodium Chloride 0.9%
Saline as a one-time, 60 milliliter injection.
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine block | Active comparator | Ropivacaine 0.375% as a one-time 60 milliliter injection. Receives: Drug: Ropivacaine |
| saline block | Placebo comparator | Sodium chloride 0.9% as a one-time 60 milliliter injection. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Control
Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.
Measured: 24 hours
Opioid Consumption
Measured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor.
Measured: 24 hours
Secondary outcomes (1)
Post-Operative Care Unit (PACU) Length of Stay
Length of PACU stay is measured from arrival in PACU to clinical discharge from PACU
Measured: From 60 minutes to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Preliminary analysis showed no difference between groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the HipStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Vaughan, The Christ Hospital
- Investigators
- Brian Vaughan, MD, Principal investigator, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299271
- Sponsor's protocol ID
- Christh-01
- Status last verified
- Feb 2017
- First submitted
- 19 Nov 2014
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shariat AN, Hadzic A, Xu D, Shastri U, Kwofie K, Gandhi K, McCally CM, Gratenstein K, Vandepitte C, Gadsden J, Unis D. Fascia lliaca block for analgesia after hip arthroplasty: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2013 May-Jun;38(3):201-5. doi: 10.1097/AAP.0b013e31828a3c7c.
PubMed 23558369
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Block for Post-Operative Pain Control After Total Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT02299271
- Acronym / sponsor ID
- Christh-01
- Conditions
- Osteoarthritis of the Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary analysis showed no difference between groups.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Nov 2014 (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.
This study evaluates post-operative pain management and narcotic consumption in patients receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca block with saline for total hip arthroplasty.
Detailed description
Although many improvements have been made in implant technology and surgical approaches for total hip arthroplasty, management of post-operative pain remains a major clinical issue. Inadequate pain control can lead to numerous unwanted side effects and limited physical function, especially in a older population. Most surgeons have adopted a multi-modality pain management approach using a variety of pharmaceuticals, including nerve block with local anesthetic. In the literature, there are a number of technical variations described for the fascia iliaca nerve block. At The Christ Hospital, Cincinnati, Ohio, anesthesiologists use a more proximal approach to the fasica iliaca block enabling a significantly easier cephalad spread of the local anesthetic into the pelvis targeting all three nerves; the femoral, lateral femoral cutaneous, and the obturator.
This prospective, double-blinded, randomized, single-center study is designed to test the primary hypothesis that fascia iliaca block with a local anesthestic decreases narcotic consumption and provides improved pain control compared to placebo in the first 24 hours after surgery in patients undergoing total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine block | Active comparator | Drug: RopivacaineRopivacaine 0.375% as a one-time 60 milliliter injection. |
| saline block | Placebo comparator | Drug: SalineSodium chloride 0.9% as a one-time 60 milliliter injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- anterior approach total hip arthroplasty (THA) for unilateral osteoarthritis
- English-speaking
- age 18 to 75 years
- American Society of Anesthesiologists (ASA) physical status 1 to 3
- BMI < 40 kg/m2
Key exclusion criteria (9 listed)
- Hip revision surgery
- Allergy to local anesthetics
- Allergy to oxycontin
- Allergy to pregabalin
- Allergy to fentanyl
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 |
|---|---|---|
| RopivacaineAlso: Naropin0.375% ropivacaine as a one-time, 60 milliliter injection | Drug | ropivacaine block |
| SalineAlso: Sodium Chloride 0.9%Saline as a one-time, 60 milliliter injection. | Drug | saline block |
Primary outcome
Pain Control
Time frame: 24 hours
Measured by NRS-11 beginning in post-operative care unit and continuing 24 hours on the post-operative floor.
Opioid Consumption
Time frame: 24 hours
Measured by IV narcotic consumption beginning in the post-operative care unit and continuing 24 hours on the post-operative floor.
1 secondary outcome
Post-Operative Care Unit (PACU) Length of Stay
Time frame: From 60 minutes to 6 hours
Results and safety
The study was stopped early (reason given: Preliminary analysis showed no difference between groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Background: PubMed 23558369Shariat AN, Hadzic A, Xu D, Shastri U, Kwofie K, Gandhi K, McCally CM, Gratenstein K, Vandepitte C, Gadsden J, Unis D. Fascia lliaca block for analgesia after hip arthroplasty: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2013 May-Jun;38(3):201-5. doi: 10.1097/AAP.0b013e31828a3c7c.
Related trials for Osteoarthritis of the Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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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.
Brian Vaughan, MD principal investigator
The Christ Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Saline in people with Osteoarthritis of the Hip, run by The Christ Hospital 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Feb 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Preliminary analysis showed no difference between groups.). Results are not available in the source record.
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?
Pain Control (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT02299271, which also lists 1 linked publication.
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 9 Feb 2017.