Postoperative PainNCT01835106
Efficacy of an Epidural Versus a Fascia Iliaca Compartment Catheter After Hip Surgery
A study testing Epidural catheter is used postoperatively and Fascia iliaca compartment catheter is used postoperatively in people with Postoperative Pain, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The investigators are investigating two ways of treating pain after hip surgery. One way is though a thin tube (called a catheter), and it is placed into the back so that pain-numbing drugs can reach the nerves near the backbone. This is called an "epidural" catheter. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Epidural catheter is used postoperatively and Fascia iliaca compartment catheter is used postoperatively
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2013
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Weight >40 kg
- Radiographic evidence of hip dysplasia amenable to unilateral surgical treatment by periacetabular osteotomy
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale >4/20
- Age between 15 and 35 years
- Good or excellent preoperative joint congruency
Who cannot join
- Hematologic or neurologic contraindications to epidural catheter placement
- Significant renal, hepatic, or cardiac disease
- Peptic ulcer disease
- Bleeding disorders
- Severe asthma
- Hypersensitivity to non-steroidal antiinflammatory drugs
Show all 10Show fewer
- Developmental delay
- History of substance abuse
- Chronic opioid use
- Chronic pain in non-hip locations
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Crossover Trial of Epidural Analgesia Versus a Surgically-placed Fascia Iliaca Compartment Catheter for Postoperative Pain After Periacetabular Osteotomy
The investigators are investigating two ways of treating pain after hip surgery. One way is though a thin tube (called a catheter), and it is placed into the back so that pain-numbing drugs can reach the nerves near the backbone. This is called an "epidural" catheter. Another way is to place the catheter close to the hip, where the surgery is done, so that the pain-numbing drugs can reach some of the nerves more locally. This is called a "fascia iliaca compartment" catheter.
The investigators do not know which way is best to treat pain, or has fewer side effects, or allows a patient to leave hospital faster. Usually, patients would receive only one type of catheter for pain relief. To do this comparison, the investigators would place both catheter types, so that patients help us tell which one works better.
- Conditions
- Postoperative Pain
- Being tested
- Epidural catheter is used postoperatively, Fascia iliaca compartment catheter is used postoperatively
- Keywords
- Postoperative Care
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural catheter is used postoperativelyProcedure or surgery
Fascia iliaca compartment catheter is used postoperativelyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Active comparator | Epidural catheter is used postoperatively Receives: Procedure: Epidural catheter is used postoperatively |
| Fascia Iliaca Compartment | Experimental | Fascia iliaca compartment catheter is used postoperatively Receives: Procedure: Fascia iliaca compartment catheter is used postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met
- Numerical pain rating score <4 at rest, and <6 with movement,
- Independence from intravenous opioids for 12 hours, and
- Ambulation at least 30 m, without a time limit
Measured: 1-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: The study was proposed but never started due to other commitments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Y. Wang, Boston Children's Hospital
- Investigators
- Luke Y Wang, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835106
- Sponsor's protocol ID
- 3650
- Status last verified
- Aug 2017
- First submitted
- 16 Apr 2013
- Last updated
- 10 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled, Crossover Trial of Epidural Analgesia Versus a Surgically-placed Fascia Iliaca Compartment Catheter for Postoperative Pain After Periacetabular Osteotomy
- ClinicalTrials.gov ID
- NCT01835106
- Acronym / sponsor ID
- 3650
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was proposed but never started due to other commitments
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Apr 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.
The investigators are investigating two ways of treating pain after hip surgery. One way is though a thin tube (called a catheter), and it is placed into the back so that pain-numbing drugs can reach the nerves near the backbone. This is called an "epidural" catheter. Another way is to place the catheter close to the hip, where the surgery is done, so that the pain-numbing drugs can reach some of the nerves more locally. This is called a "fascia iliaca compartment" catheter.
The investigators do not know which way is best to treat pain, or has fewer side effects, or allows a patient to leave hospital faster. Usually, patients would receive only one type of catheter for pain relief. To do this comparison, the investigators would place both catheter types, so that patients help us tell which one works better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | Active comparator | Procedure: Epidural catheter is used postoperativelyEpidural catheter is used postoperatively |
| Fascia Iliaca Compartment | Experimental | Procedure: Fascia iliaca compartment catheter is used postoperativelyFascia iliaca compartment catheter is used postoperatively |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Weight >40 kg
- Radiographic evidence of hip dysplasia amenable to unilateral surgical treatment by periacetabular osteotomy
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale >4/20
- Age between 15 and 35 years
- Good or excellent preoperative joint congruency
Key exclusion criteria (10 listed)
- Hematologic or neurologic contraindications to epidural catheter placement
- Significant renal, hepatic, or cardiac disease
- Peptic ulcer disease
- Bleeding disorders
- Severe asthma
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 |
|---|---|---|
| Epidural catheter is used postoperatively | Procedure or surgery | Epidural |
| Fascia iliaca compartment catheter is used postoperatively | Procedure or surgery | Fascia Iliaca Compartment |
Primary outcome
Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met
Time frame: 1-5 days
1. Numerical pain rating score <4 at rest, and <6 with movement, 2. Independence from intravenous opioids for 12 hours, and 3. Ambulation at least 30 m, without a time limit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
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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.
Luke Y Wang, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural catheter is used postoperatively and Fascia iliaca compartment catheter is used postoperatively in people with Postoperative Pain, run by Boston Children's 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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 10 Aug 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met (time frame: 1-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2017.