Strain of Muscle and/or Tendon of Lower LegNCT01542840
Onset Time of Nerve Block: A Comparison of Two Injection Locations in Patients Having Lower Leg/ Foot Surgery
An observational study of Strain of Muscle and/or Tendon of Lower Leg and Fracture of Lower Leg, run by Ochsner Health System at 1 site in United States.
Trial summary
The purpose of this study is to compare injecting local anesthetic (numbing medication) in different patterns around a major nerve in the leg. Patients who undergo surgery to the lower leg and/or foot are usually offered the option of a nerve block to help with pain control after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Strain of Muscle and/or Tendon of Lower Leg, Fracture of Lower Leg, Crushing Injury of Lower Leg
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Mar 2016
- 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: All patients undergoing lower leg and/or foot surgery at Ochsner Clinic Foundation's Main Campus.
Who may be able to join
- undergoing lower leg and/or foot surgery
- ASA Physical status I-III
- ability to give informed consent
- age 18 years old or older
Who cannot join
- true allergy to local anesthetics, not sensitivity, as determined by investigator
- bilateral lower extremity surgery
- patient refusal
- infection at the injection site
- peripheral neuropathy of lower extremity as documented by electromyography studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Kristie D Osteen, MD, 504-842-3755, kosteen@ochsner.org
Kristie D Osteen, MD
About this study
Official title: Onset Time of Ultrasound-Guided Popliteal Sciatic Nerve Block: Comparing Circumferential Injection of Local Anesthetic to Injection That Separates the Nerve in Its Two Components
The purpose of this study is to compare injecting local anesthetic (numbing medication) in different patterns around a major nerve in the leg. Patients who undergo surgery to the lower leg and/or foot are usually offered the option of a nerve block to help with pain control after surgery. A nerve block involves injecting local anesthetic (numbing medicine) by a nerve or nerves that provide sensation to the area where surgery will be performed. The local anesthetic (numbing medication) numbs up the area where the surgery is performed and helps decrease the amount of pain felt after surgery. The local anesthetic (numbing medication) can be injected in various patterns by a nerve, such as in one spot by a nerve or completely surrounding a nerve. The local anesthetic will be either injected around the sciatic nerve or will injected in a way that will split the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve.
The hypothesis is that subjects in the group that local anesthetic is injected in a pattern that separates the sciatic nerve into the two component nerves may have a faster onset time of regional anesthesia and block success than subjects in the group that have the local anesthetic injected at around the nerve.
Read the detailed description
After the consent form is signed, subjects will be randomly assigned (like the flip of a coin) to either receive the local anesthestic (numbing medication) around the sciatic nerve or in a pattern that separates the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve.
Before the nerve block is performed, the movement and sensation in the subject's foot will be checked to make sure it is normal. They will be asked to move their foot up and down. Using a blunt safety needle, their foot will be gently touched in different places to see if they can feel sharp sensations.
The amount of relaxation medication before the block will be recorded. The local anesthetic (numbing medication) will be injected in the pattern subjects were randomly assigned. The time it takes from the moment they are asked to say their name and birthday until they cannot move or feel their foot will be recorded.
Five minutes from the time the injection is complete, subjects will be asked to move their foot up and down. Also, their foot will be gently touched in different places with a blunt safety needle to see if they can still feel sharp sensations. Subjects will be asked to do this every five minutes until they cannot feel any sensation in their foot or if thirty minutes pass.
A member of the study team will contact subjects by telephone in about a week to see if they have any pain, numbness, and/or weakness in their leg/foot.
- Conditions
- Strain of Muscle and/or Tendon of Lower Leg, Fracture of Lower Leg, Crushing Injury of Lower Leg, Fracture Malunion - Ankle and/or Foot, Disorder of Joint of Ankle and/or Foot, Complete Tear, Ankle and/or Foot Ligament
- Keywords
- surgery, orthopedic surgery, foot surgery, leg surgery, ankle surgery, leg, foot, ankle, anesthesia, local anesthesia, regional anesthesia, Ochsner Clinic, Ochsner Hospital, New Orleans, Louisiana, Kristie Osteen, MD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMay 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strain of Muscle and/or Tendon of Lower LegStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristie Osteen, Ochsner Health System
- Investigators
- Kristie D Osteen, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542840
- Sponsor's protocol ID
- 2011.200.C
- Status last verified
- Mar 2014
- First submitted
- 27 Feb 2012
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset Time of Ultrasound-Guided Popliteal Sciatic Nerve Block: Comparing Circumferential Injection of Local Anesthetic to Injection That Separates the Nerve in Its Two Components
- ClinicalTrials.gov ID
- NCT01542840
- Acronym / sponsor ID
- 2011.200.C
- Conditions
- Strain of Muscle and/or Tendon of Lower Leg, Fracture of Lower Leg, Crushing Injury of Lower Leg, Fracture Malunion - Ankle and/or Foot, Disorder of Joint of Ankle and/or Foot, Complete Tear, Ankle and/or Foot Ligament
- Keywords
- surgery, orthopedic surgery, foot surgery, leg surgery, ankle surgery, leg, foot, ankle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 2 Mar 2012 (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 compare injecting local anesthetic (numbing medication) in different patterns around a major nerve in the leg. Patients who undergo surgery to the lower leg and/or foot are usually offered the option of a nerve block to help with pain control after surgery. A nerve block involves injecting local anesthetic (numbing medicine) by a nerve or nerves that provide sensation to the area where surgery will be performed. The local anesthetic (numbing medication) numbs up the area where the surgery is performed and helps decrease the amount of pain felt after surgery. The local anesthetic (numbing medication) can be injected in various patterns by a nerve, such as in one spot by a nerve or completely surrounding a nerve. The local anesthetic will be either injected around the sciatic nerve or will injected in a way that will split the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve.
The hypothesis is that subjects in the group that local anesthetic is injected in a pattern that separates the sciatic nerve into the two component nerves may have a faster onset time of regional anesthesia and block success than subjects in the group that have the local anesthetic injected at around the nerve.
Detailed description
After the consent form is signed, subjects will be randomly assigned (like the flip of a coin) to either receive the local anesthestic (numbing medication) around the sciatic nerve or in a pattern that separates the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve.
Before the nerve block is performed, the movement and sensation in the subject's foot will be checked to make sure it is normal. They will be asked to move their foot up and down. Using a blunt safety needle, their foot will be gently touched in different places to see if they can feel sharp sensations.
The amount of relaxation medication before the block will be recorded. The local anesthetic (numbing medication) will be injected in the pattern subjects were randomly assigned. The time it takes from the moment they are asked to say their name and birthday until they cannot move or feel their foot will be recorded.
Five minutes from the time the injection is complete, subjects will be asked to move their foot up and down. Also, their foot will be gently touched in different places with a blunt safety needle to see if they can still feel sharp sensations. Subjects will be asked to do this every five minutes until they cannot feel any sensation in their foot or if thirty minutes pass.
A member of the study team will contact subjects by telephone in about a week to see if they have any pain, numbness, and/or weakness in their leg/foot.
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
- All patients undergoing lower leg and/or foot surgery at Ochsner Clinic Foundation's Main Campus.
Key inclusion criteria (4 listed)
- undergoing lower leg and/or foot surgery
- ASA Physical status I-III
- ability to give informed consent
- age 18 years old or older
Key exclusion criteria (5 listed)
- true allergy to local anesthetics, not sensitivity, as determined by investigator
- bilateral lower extremity surgery
- patient refusal
- infection at the injection site
- peripheral neuropathy of lower extremity as documented by electromyography studies
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
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.
Kristie D Osteen, MD principal investigator
Ochsner Health System
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 Strain of Muscle and/or Tendon of Lower Leg and Fracture of Lower Leg, run by Ochsner Health System 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 4 inclusion and 5 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 21 Mar 2014. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 21 Mar 2014.