Postoperative PainNCT00358241
Effects of Nerve Block on Knee Function After Knee Replacement
A study testing Nerve block in people with Postoperative Pain, run by Johns Hopkins University at 1 site in United States.
Trial summary
Early physical therapy after knee surgery is very painful on top of pain from surgery. Pain following surgery can limit recovery. One way to treat pain is by giving intravenous (IV) pain medication with morphine. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 21 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Age 21-80 year old
- ASA Physical Status ASA I and II
- Mentally competent
- Intellectually competent
- Body mass index <35
- No severe cardiac diseases
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- No severe pulmonary diseases
- Unilateral knee disease
- No other lower extremity joint disease
- No chronic narcotic therapy or illicit drug use
Who cannot join
- Age <21 or >80 year old
- ASA Physical Status >ASA II
- Mentally incompetent
- Intellectually incompetent or cognitively impaired
- Non-English speaking patient
- Worker's compensation patient
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- Body mass index > 35
- Bilateral knee disease
- Has other lower extremity joint disease
- Severe cardiac diseases
- Severe pulmonary diseases
- Chronic narcotic therapy or illicit drug use
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Effects of Continuous Lumbar Plexus Nerve Block on Functional Restoration and Outcome After Unilateral Total Knee Arthroplasty
Early physical therapy after knee surgery is very painful on top of pain from surgery. Pain following surgery can limit recovery. One way to treat pain is by giving intravenous (IV) pain medication with morphine. Another method is to use a "nerve block" which involves placing a thin catheter (tube) into the lower back near the nerves that sense pain in the knee and give a local anesthetic to numb the nerves. Sometimes both methods are used together. This research is being done to determine whether nerve blocks with a local anesthetic improve knee recovery in addition to providing pain relief as compared to IV pain medicine alone
- Conditions
- Postoperative Pain
- Being tested
- Nerve block
- Keywords
- Nerve block, postoperative pain, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
Why it stopped: PI left JHU and is not able to be reached for updates
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 Johns Hopkins UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J Hang, MD, PhD, Principal investigator, Johns Hopkins Medicine, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358241
- Sponsor's protocol ID
- 04-03-05-05
- Status last verified
- May 2019
- First submitted
- 27 Jul 2006
- Last updated
- 18 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Lumbar Plexus Nerve Block on Functional Restoration and Outcome After Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00358241
- Acronym / sponsor ID
- 04-03-05-05
- Conditions
- Postoperative Pain
- Keywords
- Nerve block, postoperative pain, analgesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left JHU and is not able to be reached for updates
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- First posted
- 31 Jul 2006 (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.
Early physical therapy after knee surgery is very painful on top of pain from surgery. Pain following surgery can limit recovery. One way to treat pain is by giving intravenous (IV) pain medication with morphine. Another method is to use a "nerve block" which involves placing a thin catheter (tube) into the lower back near the nerves that sense pain in the knee and give a local anesthetic to numb the nerves. Sometimes both methods are used together. This research is being done to determine whether nerve blocks with a local anesthetic improve knee recovery in addition to providing pain relief as compared to IV pain medicine alone
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 21-80 year old
- ASA Physical Status ASA I and II
- Mentally competent
- Intellectually competent
- Body mass index <35
Key exclusion criteria (13 listed)
- Age <21 or >80 year old
- ASA Physical Status >ASA II
- Mentally incompetent
- Intellectually incompetent or cognitively impaired
- Non-English speaking patient
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 |
|---|---|---|
| Nerve block | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 18 May 2020.
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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.
J Hang, MD, PhD principal investigator
Johns Hopkins Medicine, Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve block in people with Postoperative Pain, run by Johns Hopkins University 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 10 inclusion and 13 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 18 May 2020. 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.
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 18 May 2020.