AnalgesiaNCT04495413
Assessment of the Effect of Age on Duration of Analgesia From Single-shot Femoral Nerve Blocks
An observational study of Analgesia, run by University of Washington at 1 site in United States.
Trial summary
Cohort study to examine the effect of age on duration of analgesia in patients receiving single-shot femoral nerve block prior to surgery, by postoperative phone follow-up questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 15 Jun 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult ambulatory surgery patients receiving a single-shot peripheral femoral nerve block preoperatively as part of their clinical anesthesia care on day-of-surgery.
Who may be able to join
- Adult patients (age >18 years)
- American Society of Anesthesiology physical status 1-3
- Having ambulatory surgery, who have received a single-shot femoral nerve block
- Able to read and understand English
- Have access to a phone after surgery
Who cannot join
- Pediatric patients (age <18 years)
- American Society of Anesthesiology physical status >3
- Unable to read and understand English
- Unable to have access to a phone after surgery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Vanessa Loland, MD, vloland@uw.edu
About this study
Cohort study to examine the effect of age on duration of analgesia in patients receiving single-shot femoral nerve block prior to surgery, by postoperative phone follow-up questionnaire.
Read the detailed description
The purpose of this study is to find out how differences in age can affect the duration of pain relief from a femoral nerve block. Complete recovery after leg surgery involves healing of tissues at the surgical site, recovery of muscle strength and range-of-motion. Some pain is normally experienced after leg surgery. At the hospital, pain is usually treated with pain medicines, and/or a nerve block procedure. A nerve block involves injecting a local anesthetic beside the nerves to numb the nerves that supply feeling to the knee joint and surrounding tissues. The choice as to whether a participant has a nerve block or not is made by the participant and their surgeon and is not determined by this research study. The study aim is to find out how long a nerve block can relieve postsurgical pain, and whether that duration is affected by the age of the participant.
- Conditions
- Analgesia
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Total duration of analgesia from peripheral femoral nerve block
Measured: From time of block placement to patient to the reported end of analgesic effect, up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start15 Jun 2020
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Loland, University of Washington
- Investigators
- Vanessa J Loland, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495413
- Sponsor's protocol ID
- STUDY00008754
- Status last verified
- Sep 2021
- First submitted
- 27 Jul 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Age on Duration of Analgesia From Single-shot Femoral Nerve Blocks
- ClinicalTrials.gov ID
- NCT04495413
- Acronym / sponsor ID
- STUDY00008754
- Conditions
- Analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 31 Jul 2020 (actual)
- 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.
Cohort study to examine the effect of age on duration of analgesia in patients receiving single-shot femoral nerve block prior to surgery, by postoperative phone follow-up questionnaire.
Detailed description
The purpose of this study is to find out how differences in age can affect the duration of pain relief from a femoral nerve block. Complete recovery after leg surgery involves healing of tissues at the surgical site, recovery of muscle strength and range-of-motion. Some pain is normally experienced after leg surgery. At the hospital, pain is usually treated with pain medicines, and/or a nerve block procedure. A nerve block involves injecting a local anesthetic beside the nerves to numb the nerves that supply feeling to the knee joint and surrounding tissues. The choice as to whether a participant has a nerve block or not is made by the participant and their surgeon and is not determined by this research study. The study aim is to find out how long a nerve block can relieve postsurgical pain, and whether that duration is affected by the age of the participant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ambulatory surgery patients receiving a single-shot peripheral femoral nerve block preoperatively as part of their clinical anesthesia care on day-of-surgery.
Key inclusion criteria (5 listed)
- Adult patients (age >18 years)
- American Society of Anesthesiology physical status 1-3
- Having ambulatory surgery, who have received a single-shot femoral nerve block
- Able to read and understand English
- Have access to a phone after surgery
Key exclusion criteria (4 listed)
- Pediatric patients (age <18 years)
- American Society of Anesthesiology physical status >3
- Unable to read and understand English
- Unable to have access to a phone after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of analgesia
Time frame: From time of block placement to patient to the reported end of analgesic effect, up to 72 hours
Total duration of analgesia from peripheral femoral nerve block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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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.
Vanessa J Loland, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia, run by University of Washington 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 4 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: status not confirmed, as of the sponsor's last update on 10 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam J Claessens, DO (206-291-7445, claessen@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: From time of block placement to patient to the reported end of analgesic effect, up to 72 hours). 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 Sep 2021.