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:

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.

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

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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