PainNCT01454518
Local Infiltration Analgesia for Hip Arthroscopy
A study testing Infiltration of local anesthetic and Normal Saline Injection in people with Pain, run by Trinity Health Of New England at 1 site in United States.
Trial summary
The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Infiltration of local anesthetic and Normal Saline Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hip arthroscopy
- ages 18-80
Who cannot join
- history of neurological disease
- diabetes
- pregnancy
- neuropathy
- chronic narcotic use
- allergy to local anesthetic solution
- inability to give consent or cooperate with the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: Effectiveness of Ultrasound Guided Hip Infiltration With Local Anesthetic Solution for Pain Control After Hip Arthroscopy
The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy.
- Conditions
- Pain
- Being tested
- Infiltration of local anesthetic, Normal Saline Injection
- Keywords
- hip arthroscopy, post operative analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration of local anestheticProcedure or surgery
30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
Normal Saline InjectionProcedure or surgery
injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Infiltration of local anesthetic | Experimental | 30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance. Receives: Procedure: Infiltration of local anesthetic |
| Normal Saline Injection | Placebo comparator | injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance. Receives: Procedure: Normal Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative opioid consumption.
Amount in milligrams of opioid consumption post surgery in the recovery room and for a 24 hour period.
Measured: Within 24 hours after surgery
Secondary outcomes (1)
Pain scores in recovery room.
Mesures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 24 hour period after discharge from recovery room.
Measured: Within 24 hours of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Sinha, M.D., Principal investigator, Saint Francis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454518
- Sponsor's protocol ID
- 11-08-003
- Status last verified
- Mar 2013
- First submitted
- 6 Oct 2011
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound Guided Hip Infiltration With Local Anesthetic Solution for Pain Control After Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT01454518
- Acronym / sponsor ID
- 11-08-003
- Conditions
- Pain
- Keywords
- hip arthroscopy, post operative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Oct 2011 (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 purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infiltration of local anesthetic | Experimental | Procedure: Infiltration of local anesthetic30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance. |
| Normal Saline Injection | Placebo comparator | Procedure: Normal Saline Injectioninjection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hip arthroscopy
- ages 18-80
Key exclusion criteria (7 listed)
- history of neurological disease
- diabetes
- pregnancy
- neuropathy
- chronic narcotic use
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 |
|---|---|---|
| Infiltration of local anesthetic30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance. | Procedure or surgery | Infiltration of local anesthetic |
| Normal Saline Injectioninjection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance. | Procedure or surgery | Normal Saline Injection |
Primary outcome
Post operative opioid consumption.
Time frame: Within 24 hours after surgery
Amount in milligrams of opioid consumption post surgery in the recovery room and for a 24 hour period.
1 secondary outcome
Pain scores in recovery room.
Time frame: Within 24 hours of the surgery
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 11 Mar 2013.
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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.
Sanjay Sinha, M.D. principal investigator
Saint Francis 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 Infiltration of local anesthetic and Normal Saline Injection in people with Pain, run by Trinity Health Of New England 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 2 inclusion and 7 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 11 Mar 2013. 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?
Post operative opioid consumption. (time frame: Within 24 hours after surgery). 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 11 Mar 2013.