- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495413
Assessment of the Effect of Age on Duration of Analgesia From Single-shot Femoral Nerve Blocks
September 8, 2021 updated by: Vanessa Loland, University of Washington
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adam J Claessens, DO
- Phone Number: 206-291-7445
- Email: claessen@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- Recruiting
- University of Washington Medical Center
-
Contact:
- Vanessa Loland, MD
- Email: vloland@uw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From time of block placement to patient to the reported end of analgesic effect, up to 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vanessa J Loland, MD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 15, 2020
Primary Completion (ANTICIPATED)
June 15, 2022
Study Completion (ANTICIPATED)
June 15, 2022
Study Registration Dates
First Submitted
July 27, 2020
First Submitted That Met QC Criteria
July 29, 2020
First Posted (ACTUAL)
July 31, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 10, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00008754
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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