OsteoarthritisNCT01409278
Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement
A study testing Ropivacaine infiltration and saline infusion., Ropivacaine infiltration and infusion. and Normal Saline in people with Osteoarthritis, run by Trinity Health Of New England at 1 site in United States.
Trial summary
The purpose of this study is to examine three different ways to control pain after hip replacement: 1. One time injection of ropivacaine before wound closure 2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours 3. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ropivacaine infiltration and saline infusion., Ropivacaine infiltration and infusion. and Normal Saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- total knee replacement
Who cannot join
- History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent
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: The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty
The purpose of this study is to examine three different ways to control pain after hip replacement:
- One time injection of ropivacaine before wound closure
- One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours
- Standard practice of patient controlled pump
- Conditions
- Osteoarthritis
- Being tested
- Ropivacaine infiltration and saline infusion., Ropivacaine infiltration and infusion., Normal Saline
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine infiltration and saline infusion.Procedure or surgery
50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour
Ropivacaine infiltration and infusion.Procedure or surgery
50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.
Normal SalineProcedure or surgery
50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine infiltration and infusion. | Experimental | Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours. Receives: Procedure: Ropivacaine infiltration and infusion. |
| Ropivacaine and Saline | Experimental | Ropivicaine infiltration followed by normal saline infusion. Receives: Procedure: Ropivacaine infiltration and saline infusion. |
| Saline infiltration and infusion. | Placebo comparator | Normal saline infiltration followed by saline infusion. Receives: Procedure: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain medication requirement for 48 hours after surgery in three groups.
Measured: 48 hours after surgery
Secondary outcomes (1)
Pain scores, incidence of nausea and vomiting and patient satisfaction in each group.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startAug 2009
- Primary completionJul 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Investigators
- Sanjay Sinha, M.D., Principal investigator, WVU Medicine Thomas Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409278
- Sponsor's protocol ID
- 09-07-002
- Status last verified
- Aug 2009
- First submitted
- 2 Aug 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01409278
- Acronym / sponsor ID
- 09-07-002
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Aug 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 three different ways to control pain after hip replacement:
- One time injection of ropivacaine before wound closure
- One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours
- Standard practice of patient controlled pump
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine infiltration and infusion. | Experimental | Procedure: Ropivacaine infiltration and infusion.Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours. |
| Ropivacaine and Saline | Experimental | Procedure: Ropivacaine infiltration and saline infusion.Ropivicaine infiltration followed by normal saline infusion. |
| Saline infiltration and infusion. | Placebo comparator | Procedure: Normal SalineNormal saline infiltration followed by saline infusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total knee replacement
Key exclusion criteria (1 listed)
- History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent
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 |
|---|---|---|
| Ropivacaine infiltration and saline infusion.50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour | Procedure or surgery | Ropivacaine and Saline |
| Ropivacaine infiltration and infusion.50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours. | Procedure or surgery | Ropivacaine infiltration and infusion. |
| Normal Saline50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour | Procedure or surgery | Saline infiltration and infusion. |
Primary outcome
The pain medication requirement for 48 hours after surgery in three groups.
Time frame: 48 hours after surgery
1 secondary outcome
Pain scores, incidence of nausea and vomiting and patient satisfaction in each group.
Time frame: 48 hours after 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 4 Aug 2011.
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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
WVU Medicine Thomas Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine infiltration and saline infusion., Ropivacaine infiltration and infusion. and Normal Saline in people with Osteoarthritis, 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 1 inclusion and 1 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 4 Aug 2011. 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?
The pain medication requirement for 48 hours after surgery in three groups. (time frame: 48 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 4 Aug 2011.