Neuromuscular InhibitionNCT01591603
Comparison of Perineural Catheter Depth for the Continuous Popliteal Nerve Block Using Ultrasound Guidance and Dermabond
A study testing 1 cm and 5 cm in people with Neuromuscular Inhibition, run by Vanderbilt University at 1 site in United States.
Trial summary
The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Inhibition
- What is being tested?
- 1 cm and 5 cm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Will be having a popliteal nerve blocks
- Do not meet any of the exclusion criteria listed below.
Who cannot join
- < 18 years old
- BMI > 35
- Pregnant patients
- Diabetes mellitus or patients with known neuropathy
- Amputations \& polytrauma patients
- Patients allergic to local anesthetics
- Chronic Pain patients
- Patients in whom communication is a problem
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.
Read the detailed description
Traditionally for the lower extremity, peripheral nerve catheters have been threaded greater than or equal to 5 centimeters past the tip of the Tuohy needle. The major rational for this practice is to reduce dislodgement. However, the greater the distance that a catheter is advanced, the greater the risk of contacting undesired structures, kinking, looping and knotting. For the continuous popliteal nerve block, the catheter is threaded perpendicular to the course of the nerve. This could result in the tip of the catheter being a significant distance from the targeted nerve which may lead to a decrease in the success rate or efficacy of the block.
Greater efficacy may be seen if the needle is closer to its target. This may be quantified by documenting a faster onset of motor and sensory changes and/or a lower catheter infusion rate required to maintain pain control. The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.
- Conditions
- Neuromuscular Inhibition
- Being tested
- 1 cm, 5 cm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 cmProcedure or surgery
Also called 18 gauge 100mm Contiplex Tuohy needle, 20-gauge non-stimulating catheter
A Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 1 cm past the tip of the Tuohy
5 cmProcedure or surgery
Also called 18 gauge 100mm Contiplex Tuohy needle, 20-gauge non-stimulating catheter
A Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 5 cm past the tip of the Tuohy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Procedure: 1 cm |
| Group 2 | Experimental | Not described Receives: Procedure: 5 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peripheral block score (PBS).
The extent of popliteal nerve blockade will be captured with four sensory groups (sural, superficial peroneal, tibial, and deep peroneal) and three motor groups (superficial peroneal, tibial, and deep peroneal). For each group, a score of 0, 1, or 2 will be assigned based on complete, partial, or no blockade, respectively. The peripheral block score (PBS) outcome variable will be based on the sum of these values and will range from 0 to 14.
Measured: 10, 20, and 30 minutes after intervention
Secondary outcomes (5)
Pain score
The investigators will examine the difference in the pain scores (0-10 numeric rating scale) between the two groups.
Measured: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Analgesia failure rate
The investigators will examine the difference in analgesia failure rates in the PACU. Analgesia failure is defined as the failure of a rescue bolus (to treat patient pain).
Measured: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Catheter dislodgement rates
The investigators will examine the difference in the catheter dislodgement rates.
Measured: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Difference in total opioid usage
The investigators will examine the difference in the total opioid usage. We will compare medications separately and in total equivalent units (using an opioid conversion table).
Measured: Length of Stay In PACU (Approximately 5-7 hours after intervention)
Degree of Doppler color agitation
The investigators will examine the relationship between the degree of Doppler color agitation (evaluated at the time the catheter is placed) and block success (i.e., the outcome in the primary analysis). Degree of agitation color will be defined as the percentage of nerve covered during the color agitation.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionJul 2015
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 Neuromuscular InhibitionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clifford Bowens, Vanderbilt University
- Investigators
- Clifford Bowens, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591603
- Sponsor's protocol ID
- 120382
- Status last verified
- Jul 2015
- First submitted
- 23 Apr 2012
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bowens C Jr, Badiola IJ, Allen BFS, Canlas CL, Gupta RK, Jaeger LM, Briggs ER, Corey JM, Shi Y, Schildcrout JS, Malchow RJ. Color Doppler ultrasonography of an agitated solution is predictive of accurate catheter placement for a continuous popliteal sciatic nerve block. Perioper Med (Lond). 2021 Dec 15;10(1):59. doi: 10.1186/s13741-021-00229-w.
PubMed 34906248
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perineural Catheter Depth for the Continuous Popliteal Nerve Block Using Ultrasound Guidance and Dermabond
- ClinicalTrials.gov ID
- NCT01591603
- Acronym / sponsor ID
- 120382
- Conditions
- Neuromuscular Inhibition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 May 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 study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.
Detailed description
Traditionally for the lower extremity, peripheral nerve catheters have been threaded greater than or equal to 5 centimeters past the tip of the Tuohy needle. The major rational for this practice is to reduce dislodgement. However, the greater the distance that a catheter is advanced, the greater the risk of contacting undesired structures, kinking, looping and knotting. For the continuous popliteal nerve block, the catheter is threaded perpendicular to the course of the nerve. This could result in the tip of the catheter being a significant distance from the targeted nerve which may lead to a decrease in the success rate or efficacy of the block.
Greater efficacy may be seen if the needle is closer to its target. This may be quantified by documenting a faster onset of motor and sensory changes and/or a lower catheter infusion rate required to maintain pain control. The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: 1 cm |
| Group 2 | Experimental | Procedure: 5 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Will be having a popliteal nerve blocks
- Do not meet any of the exclusion criteria listed below.
Key exclusion criteria (8 listed)
- < 18 years old
- BMI > 35
- Pregnant patients
- Diabetes mellitus or patients with known neuropathy
- Amputations \& polytrauma patients
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 |
|---|---|---|
| 1 cmAlso: 18 gauge 100mm Contiplex Tuohy needle, 20-gauge non-stimulating catheterA Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 1 cm past the tip of the Tuohy | Procedure or surgery | Group 1 |
| 5 cmAlso: 18 gauge 100mm Contiplex Tuohy needle, 20-gauge non-stimulating catheterA Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 5 cm past the tip of the Tuohy | Procedure or surgery | Group 2 |
Primary outcome
Change in Peripheral block score (PBS).
Time frame: 10, 20, and 30 minutes after intervention
The extent of popliteal nerve blockade will be captured with four sensory groups (sural, superficial peroneal, tibial, and deep peroneal) and three motor groups (superficial peroneal, tibial, and deep peroneal). For each group, a score of 0, 1, or 2 will be assigned based on complete, partial, or no blockade, respectively. The peripheral block score (PBS) outcome variable will be based on the sum of these values and will range from 0 to 14.
5 secondary outcomes
Pain score
Time frame: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Analgesia failure rate
Time frame: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Catheter dislodgement rates
Time frame: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Difference in total opioid usage
Time frame: Length of Stay In PACU (Approximately 5-7 hours after intervention)
Degree of Doppler color agitation
Time frame: Immediately after intervention
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 Jul 2015.
- Derived from this study: PubMed 34906248Bowens C Jr, Badiola IJ, Allen BFS, Canlas CL, Gupta RK, Jaeger LM, Briggs ER, Corey JM, Shi Y, Schildcrout JS, Malchow RJ. Color Doppler ultrasonography of an agitated solution is predictive of accurate catheter placement for a continuous popliteal sciatic nerve block. Perioper Med (Lond). 2021 Dec 15;10(1):59. doi: 10.1186/s13741-021-00229-w.
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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.
Clifford Bowens, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 cm and 5 cm in people with Neuromuscular Inhibition, run by Vanderbilt University 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 2 inclusion and 8 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 Jul 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.
What does the primary outcome measure?
Change in Peripheral block score (PBS). (time frame: 10, 20, and 30 minutes after intervention). 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 NCT01591603, 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 Jul 2015.