HealthyPhase 1TLIPNCT02297191
Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane
A Phase 1 study testing Thoracolumbar Interfascial Plane Block and Ropivicaine in people with Healthy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of the study is to determine the effectiveness of a new approach to numbing (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on the skin of the back. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Thoracolumbar Interfascial Plane Block and Ropivicaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Nov 2014
- Phase
- Phase 1
- 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
Who may be able to join
- Healthy Adult
Who cannot join
- Pregnant women (a urine pregnancy test will be done on all females of childbearing age)
- Liver dysfunction
- Elderly
- Impaired cardiovascular function
- Individuals on amiodarone or history of back surgery
- History of medical allergy to local amide type local anesthetics
Show all 12Show fewer
- Medical allergy to chlorhexidine
- History of paresthesias
- Inability to lay flat
- Home oxygen requirement
- History of seizures
- Only adults will be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Ultrasound Guided Local Anesthetic Field Block Within the Thoracolumbar Interfascial Plane: Distribution of Pain and Temperature Sensation Loss in Healthy Volunteers
The purpose of the study is to determine the effectiveness of a new approach to numbing (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on the skin of the back.
Read the detailed description
This research aims to define a novel field-infiltration nerve block. We will use ultrasound guidance to inject local anesthesia into the potential space between the muscle bodies of the erector spinae. The medial branch of the dorsal ramus of each thoracolumbar nerve innervates the muscle and skin overlying the erector spinae muscle to the midline. By anesthetizing each nerve we believe minimally invasive (1-2 level) back surgery may be completed with less pain and preclude the side-effect laden opioid analgesics.
- Conditions
- Healthy
- Being tested
- Thoracolumbar Interfascial Plane Block, Ropivicaine
- Keywords
- volunteer, pilot study, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar Interfascial Plane BlockProcedure or surgery
All participants will have two injections at the same vertebral level on each side of the back. Each injection will consist of four 5cc incremental injections with aspiration prior to each 5cc of injectate of 0.5% Ropivicaine. . Each side of the back will be injected with 20cc of .05% Ropivicaine. Ultrasound will be used in real time to guide the needle.
- Ultrasound images will be saved using the nomenclature TLIP Anatomy
- Photos will only include surface anatomy of the low-to-mid back.
- Participants will be assessed for evidence of adverse reaction to local anesthesia (tinnitus, disorientation, or perioral numbness) with each 5cc dose of local anesthetic. If any adverse reactions are noted the dosing will be stopped.
RopivicaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumbar Interfascial Plane Block | Experimental | All participants will have two injections at the same vertebral level on each side of the back. Each injection will consist of four 5cc incremental injections with aspiration prior to each 5cc of injectate of 0.5% Ropivicaine. . Each side of the back will be injected with 20cc of .05% Ropivicaine. Ultrasound will be used in real time to guide the needle, evaluate for "spread" of local anesthesia and to minimize the risk of Ropivicaine being injected intravascularly.
a. Ultrasound images will be saved using the nomenclature TLIP Anat Receives: Procedure: Thoracolumbar Interfascial Plane Block; Drug: Ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia (monitoring of pain, temperature, and adverse reaction to anesthesia [tinnitus, disorientation, or perioral numbness])
At time zero (pre injection), 5 minutes, and 15 minutes point-discrimination to pain and temperature will be evaluated by blunt-needle prick and ice (in plastic bag). A "map" of each will be drawn and photographed for analysis.
- Photos will only include surface anatomy of the low-to-mid back.
- Participants will be assessed for evidence of adverse reaction to local anesthesia (tinnitus, disorientation, or perioral numbness) with each 5cc dose of local anesthetic.
Measured: The day of procedure (up to 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Hand, MD, Principal investigator, Medical University of South CarolinaScott T Reeves, MD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297191
- Sponsor's protocol ID
- TLIP Block
- Other IDs
- Pro00033609
- Acronym
- TLIP
- Status last verified
- Mar 2016
- First submitted
- 28 Jul 2014
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
PubMed 26149600
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Local Anesthetic Field Block Within the Thoracolumbar Interfascial Plane: Distribution of Pain and Temperature Sensation Loss in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02297191
- Acronym / sponsor ID
- TLIP / TLIP Block
- Conditions
- Healthy
- Keywords
- volunteer, pilot study, adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Nov 2014 (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 the study is to determine the effectiveness of a new approach to numbing (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on the skin of the back.
Detailed description
This research aims to define a novel field-infiltration nerve block. We will use ultrasound guidance to inject local anesthesia into the potential space between the muscle bodies of the erector spinae. The medial branch of the dorsal ramus of each thoracolumbar nerve innervates the muscle and skin overlying the erector spinae muscle to the midline. By anesthetizing each nerve we believe minimally invasive (1-2 level) back surgery may be completed with less pain and preclude the side-effect laden opioid analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar Interfascial Plane Block | Experimental | Procedure: Thoracolumbar Interfascial Plane Block, Drug: RopivicaineAll participants will have two injections at the same vertebral level on each side of the back. Each injection will consist of four 5cc incremental injections with aspiration prior to each 5cc of injectate of 0.5% Ropivicaine. . Each side of the back will be injected with 20cc of .05% Ropivicaine. Ultrasound will be used in real time to guide the needle, evaluate for "spread" of local anesthesia and to minimize the risk of Ropivicaine being injected intravascularly. a. Ultrasound images will be saved using the nomenclature TLIP Anat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Adult
Key exclusion criteria (12 listed)
- Pregnant women (a urine pregnancy test will be done on all females of childbearing age)
- Liver dysfunction
- Elderly
- Impaired cardiovascular function
- Individuals on amiodarone or history of back surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracolumbar Interfascial Plane BlockAll participants will have two injections at the same vertebral level on each side of the back. Each injection will consist of four 5cc incremental injections with aspiration prior to each 5cc of injectate of 0.5% Ropivicaine. . Each side of the back will be injected with 20cc of .05% Ropivicaine. Ultrasound will be used in real time to guide the needle. 1. Ultrasound images will be saved using the nomenclature TLIP Anatomy 2. Photos will only include surface anatomy of the low-to-mid back. 3. Participants will be assessed for evidence of adverse reaction to local anesthesia (tinnitus, disorientation, or perioral numbness) with each 5cc dose of local anesthetic. If any adverse reactions are noted the dosing will be stopped. | Procedure or surgery | Thoracolumbar Interfascial Plane Block |
| Ropivicaine | Drug | Thoracolumbar Interfascial Plane Block |
Primary outcome
Anesthesia (monitoring of pain, temperature, and adverse reaction to anesthesia [tinnitus, disorientation, or perioral numbness])
Time frame: The day of procedure (up to 15 minutes)
At time zero (pre injection), 5 minutes, and 15 minutes point-discrimination to pain and temperature will be evaluated by blunt-needle prick and ice (in plastic bag). A "map" of each will be drawn and photographed for analysis. 1. Photos will only include surface anatomy of the low-to-mid back. 2. Participants will be assessed for evidence of adverse reaction to local anesthesia (tinnitus, disorientation, or perioral numbness) with each 5cc dose of local anesthetic.
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 20 Jun 2018.
- Derived from this study: PubMed 26149600Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
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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.
William Hand, MD principal investigator
Medical University of South Carolina
Scott T Reeves, MD study chair
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thoracolumbar Interfascial Plane Block and Ropivicaine in people with Healthy, run by Medical University of South Carolina 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 1 inclusion and 12 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 20 Jun 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Anesthesia (monitoring of pain, temperature, and adverse reaction to anesthesia [tinnitus, disorientation, or perioral numbness]) (time frame: The day of procedure (up to 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02297191, which also lists 1 linked publication.
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 20 Jun 2018.