Strain of Muscle and/or Tendon of Lower LegNCT01550094
A Comparison of Two Injection Locations in Obese 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 Jose Soberon, MD at 1 site in United States.
Trial summary
One technique for the nerve block involves injecting the numbing medicine where the nerve is together (higher up in the back of the thigh). The other technique involves injecting the numbing medicine where the nerve splits into two parts. 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Oct 2015
- 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: Severely and morbidly obese patients scheduled for foot or ankle surgery.
Who may be able to join
- Patients ≥ 18 years of age undergoing unilateral foot and/or ankle surgery
- Severe or morbid obesity, defined as a BMI of 35-39 or ≥ 40, respectively
- ASA status I-IV
- Ability to understand and provide informed consent
Who cannot join
- True allergy, not sensitivity, to any of the following substances:
- Local Anesthetics Midazolam Fentanyl Hydromorphone Propofol
- Pregnancy
- Evidence of infection at or near the proposed needle insertion site
- Unstable or undetermined neurologic disease of the lower extremity
- Chronic pain patients
- Patient refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
About this study
Official title: Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations
One technique for the nerve block involves injecting the numbing medicine where the nerve is together (higher up in the back of the thigh). The other technique involves injecting the numbing medicine where the nerve splits into two parts. By injecting numbing medication around the nerve(s), there will be less pain after the procedure. It is thought that the numbing medicine will be easier to inject in the group that the nerves are split. It is expected that subjects may need less pain medication and have lower pain ratings in this group too.
Read the detailed description
The purpose of this study is to compare two different techniques for placement of nerve blocks for your foot or ankle procedure. A nerve block involves injecting numbing medications around a nerve to decrease pain after surgery. An ultrasound machine is often used to help see the nerve before injecting the numbing medicine. When an ultrasound machine is used during a block it is called an ultrasound-guided block.
Many studies of ultrasound-guided nerve blocks have involved mostly thin patients, especially from foreign countries. This study is different because the investigators are looking at patients living in America with a body mass index (a measure of the amount of body fat a person has) of more than 35.
The Sciatic nerve is a large nerve that provides most of the feeling and all of the movement to the foot and ankle. The nerve travels under the back of the leg, and splits into two smaller nerves slightly above the knee.
- 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, Complete Tear, Ankle and/or Foot Ligament, Pathological Fracture - Ankle and/or Foot
- Keywords
- obese, regional anesthesia, anesthesia, anesthesiology, surgery, foot, foot surgery, ankle, ankle surgery, orthopedics, orthopedic surgery, sports medicine, sports medicine surgery, Ochsner Hospital, Ochsner Clinic, New Orleans, Louisiana, Jefferson, Soberon
- Medical subject headings
- Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2015
- Study completionOct 2015
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Soberon, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Soberon, MD, Ochsner Health System
- Investigators
- Jose Soberon, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550094
- Sponsor's protocol ID
- 2011.191.B
- Other IDs
- 2011.191.B
- Status last verified
- Oct 2015
- First submitted
- 7 Mar 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations
- ClinicalTrials.gov ID
- NCT01550094
- Acronym / sponsor ID
- 2011.191.B
- 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, Complete Tear, Ankle and/or Foot Ligament, Pathological Fracture - Ankle and/or Foot
- Keywords
- obese, regional anesthesia, anesthesia, anesthesiology, surgery, foot, foot surgery, ankle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jose Soberon, MDUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 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.
One technique for the nerve block involves injecting the numbing medicine where the nerve is together (higher up in the back of the thigh). The other technique involves injecting the numbing medicine where the nerve splits into two parts. By injecting numbing medication around the nerve(s), there will be less pain after the procedure. It is thought that the numbing medicine will be easier to inject in the group that the nerves are split. It is expected that subjects may need less pain medication and have lower pain ratings in this group too.
Detailed description
The purpose of this study is to compare two different techniques for placement of nerve blocks for your foot or ankle procedure. A nerve block involves injecting numbing medications around a nerve to decrease pain after surgery. An ultrasound machine is often used to help see the nerve before injecting the numbing medicine. When an ultrasound machine is used during a block it is called an ultrasound-guided block.
Many studies of ultrasound-guided nerve blocks have involved mostly thin patients, especially from foreign countries. This study is different because the investigators are looking at patients living in America with a body mass index (a measure of the amount of body fat a person has) of more than 35.
The Sciatic nerve is a large nerve that provides most of the feeling and all of the movement to the foot and ankle. The nerve travels under the back of the leg, and splits into two smaller nerves slightly above the knee.
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
- Severely and morbidly obese patients scheduled for foot or ankle surgery.
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age undergoing unilateral foot and/or ankle surgery
- Severe or morbid obesity, defined as a BMI of 35-39 or ≥ 40, respectively
- ASA status I-IV
- Ability to understand and provide informed consent
Key exclusion criteria (7 listed)
- True allergy, not sensitivity, to any of the following substances:
- Local Anesthetics Midazolam Fentanyl Hydromorphone Propofol
- Pregnancy
- Evidence of infection at or near the proposed needle insertion site
- Unstable or undetermined neurologic disease of the lower extremity
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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.
Jose Soberon, 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 Jose Soberon, MD 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 7 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: finished, as of the sponsor's last update on 14 Oct 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 14 Oct 2015.