Pain, PostoperativeNCT01459523

Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks

A study testing Proximal placement, Short axis ultrasound and Long axis in people with Pain, Postoperative, run by VA Palo Alto Health Care System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative
What is being tested?: Proximal placement, Short axis ultrasound and Long axis
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Oct 2011to May 2014
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

At least 18 years of age;
Undergoing unilateral, upper (at or distal to the elbow) or lower (hip or distal) extremity orthopedic surgery, with moderate-to-severe postoperative pain expected; and
Desiring a continuous perineural catheter for postoperative analgesia.

Who cannot join

Patients who will have difficulty understanding the study protocol or caring for the infusion pump/catheter system; or
Patients with any known contraindication to study medications, insulin-dependent diabetes mellitus, neuropathy of any etiology in the affected extremity;
Patients with a contraindication to regional blockade (eg, clotting deficiency);
Patients with any known acute or chronic hepatic or renal insufficiency or failure;
Patients with any additional surgical site outside of the catheter-affected area (eg, iliac crest bone graft in addition to hand surgery);
Patients with chronic opioid use (defined as daily use for more than 4 weeks prior to surgery) or active illicit substance abuse;

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Patient weighing < 40 kg;
Pregnancy;
Incarceration; or
Inability to communicate with the investigators and hospital staff.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Palo Alto Health System
Palo Alto, California, 94304

Other trials in United States

About this study

Continuous peripheral nerve blocks (CPNB; also known as "perineural" catheters) provide target-specific pain control for a variety of surgeries. There has been increasing interest in the use of ultrasound guidance for regional anesthesia, and many techniques using ultrasound alone for perineural catheter insertion have been described. Catheters may be placed at various points along the brachial plexus (for upper extremity procedures) or in proximity to the femoral and/or sciatic nerve (for lower extremity procedures). To date, the optimal ultrasound scanning technique, catheter insertion endpoint, catheter placement location per indication, for the majority of ultrasound-guided continuous peripheral nerve blocks remain unknown. This study will help provide important information related to optimal ultrasound scanning techniques and will help identify ways to improve the success rates, onset times, and analgesic effectiveness of these techniques for real patients undergoing surgical procedures.

Read the detailed description

Primary Aim: To determine if there is an optimal scanning technique for ultrasound-guided perineural catheter insertion that will result in the most accurate tip placement in proximity to the target nerve or plexus.

Secondary Aim: To determine if there is an optimal location for ultrasound-guided perineural catheter insertion along a target nerve or plexus that will result in maximum local anesthetic infusion benefits.

Conditions: Pain, Postoperative
Being tested: Proximal placement, Short axis ultrasound, Long axis, Distal placement
Keywords: Peripheral Nerve Block, Perineural Catheter, Orthopedic Surgery, Ultrasound
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proximal placementProcedure or surgery
Also called Perineural catheter, Ultrasound, Catheter placement technique
Subjects assigned to this group will have their perineural catheter placed in a proximal position (higher up in the arm or leg) with ultrasound guidance. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
Short axis ultrasoundProcedure or surgery
Also called Perineural catheter, Ultrasound, Catheter placement technique
Subjects assigned to this group will have the target nerve or plexus identified in short axis (cross-section) using ultrasound. Perineural catheter insertion will be performed in-plane. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
Long axisProcedure or surgery
Also called Perineural catheter, Ultrasound, Catheter placement technique
Subjects assigned to this group will have the target nerve or plexus identified in long axis (longitudinal) using ultrasound. Perineural catheter insertion will be performed in-plane. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
Distal placementProcedure or surgery
Also called Perineural catheter, Ultrasound, Catheter placement technique
Subjects assigned to this group will have their perineural catheter placed in a distal position (further down in the arm or leg) with ultrasound guidance. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.

Study groups in NCT01459523
Study group	Role	What they receive
Imaging technique	Active comparator	In one substudy, subjects will be randomly assigned to either short axis or long axis target ultrasound imaging for perineural catheter insertion. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter. Receives: Procedure: Short axis ultrasound; Procedure: Long axis
Catheter location	Active comparator	In another substudy, subjects will be randomly assigned to receive their perineural catheters either proximally or distally along the same target nerve or plexus. Receives: Procedure: Proximal placement; Procedure: Distal placement

What is being measured

The primary outcome is the main question the study is designed to answer.

Onset time of sensory anesthesia
The primary outcome will be the onset time of sensory anesthesia in the target nerve distribution following injection of a local anesthetic bolus via the perineural catheter.
Measured: 30 minutes

Secondary outcomes (2)

Time for placement
A secondary outcome measure will be the time required to insert the perineural catheter using the technique or location assigned.
Measured: 30 minutes
Postoperative pain
A secondary outcome will be the surgical pain experienced by subjects as assessed by a 0-10 scale (0=no pain; 10=worst pain imaginable) and amount of opioid medications consumed.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011May 2014

First posted25 Oct 2011 (estimated)
Study startOct 2011
Primary completionApr 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies 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: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01459523
Sponsor's protocol ID: 21961
Status last verified: Apr 2021
First submitted: 21 Oct 2011
Last updated: 4 May 2021
Results posted: No
Data monitoring committee: No

Publications

Grant SA, Nielsen KC, Greengrass RA, Steele SM, Klein SM. Continuous peripheral nerve block for ambulatory surgery. Reg Anesth Pain Med. 2001 May-Jun;26(3):209-14. doi: 10.1053/rapm.2001.22256.
PubMed 11359219
Mariano ER, Cheng GS, Choy LP, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Lee DK, Maldonado RC, Ilfeld BM. Electrical stimulation versus ultrasound guidance for popliteal-sciatic perineural catheter insertion: a randomized controlled trial. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):480-5. doi: 10.1097/AAP.0b013e3181ada57a.
PubMed 19920423
Mariano ER, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Abrams RA, Meunier MJ, Maldonado RC, Ferguson EJ, Ilfeld BM. Ultrasound guidance versus electrical stimulation for infraclavicular brachial plexus perineural catheter insertion. J Ultrasound Med. 2009 Sep;28(9):1211-8. doi: 10.7863/jum.2009.28.9.1211.
PubMed 19710219
Mariano ER, Loland VJ, Sandhu NS, Bishop ML, Lee DK, Schwartz AK, Girard PJ, Ferguson EJ, Ilfeld BM. Comparative efficacy of ultrasound-guided and stimulating popliteal-sciatic perineural catheters for postoperative analgesia. Can J Anaesth. 2010 Oct;57(10):919-26. doi: 10.1007/s12630-010-9364-7. Epub 2010 Aug 11.
PubMed 20700680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Catheter Insertion Technique for Ultrasound-guided Continuous Peripheral Nerve Blocks
ClinicalTrials.gov ID: NCT01459523
Acronym / sponsor ID: 21961
Conditions: Pain, Postoperative
Keywords: Peripheral Nerve Block, Perineural Catheter, Orthopedic Surgery, Ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: VA Palo Alto Health Care SystemUS federal agency
Study start: Oct 2011
Primary completion: Apr 2014 (actual)
Study completion: May 2014 (actual)
First posted: 25 Oct 2011 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Imaging technique	Active comparator	Procedure: Short axis ultrasound, Procedure: Long axisIn one substudy, subjects will be randomly assigned to either short axis or long axis target ultrasound imaging for perineural catheter insertion. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
Catheter location	Active comparator	Procedure: Proximal placement, Procedure: Distal placementIn another substudy, subjects will be randomly assigned to receive their perineural catheters either proximally or distally along the same target nerve or plexus.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least 18 years of age;
Undergoing unilateral, upper (at or distal to the elbow) or lower (hip or distal) extremity orthopedic surgery, with moderate-to-severe postoperative pain expected; and
Desiring a continuous perineural catheter for postoperative analgesia.

Key exclusion criteria (10 listed)

Patients who will have difficulty understanding the study protocol or caring for the infusion pump/catheter system; or
Patients with any known contraindication to study medications, insulin-dependent diabetes mellitus, neuropathy of any etiology in the affected extremity;
Patients with a contraindication to regional blockade (eg, clotting deficiency);
Patients with any known acute or chronic hepatic or renal insufficiency or failure;
Patients with any additional surgical site outside of the catheter-affected area (eg, iliac crest bone graft in addition to hand 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
Proximal placementAlso: Perineural catheter, Ultrasound, Catheter placement techniqueSubjects assigned to this group will have their perineural catheter placed in a proximal position (higher up in the arm or leg) with ultrasound guidance. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.	Procedure or surgery	Catheter location
Short axis ultrasoundAlso: Perineural catheter, Ultrasound, Catheter placement techniqueSubjects assigned to this group will have the target nerve or plexus identified in short axis (cross-section) using ultrasound. Perineural catheter insertion will be performed in-plane. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.	Procedure or surgery	Imaging technique
Long axisAlso: Perineural catheter, Ultrasound, Catheter placement techniqueSubjects assigned to this group will have the target nerve or plexus identified in long axis (longitudinal) using ultrasound. Perineural catheter insertion will be performed in-plane. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.	Procedure or surgery	Imaging technique
Distal placementAlso: Perineural catheter, Ultrasound, Catheter placement techniqueSubjects assigned to this group will have their perineural catheter placed in a distal position (further down in the arm or leg) with ultrasound guidance. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.	Procedure or surgery	Catheter location

Primary outcome

Onset time of sensory anesthesia
Time frame: 30 minutes
The primary outcome will be the onset time of sensory anesthesia in the target nerve distribution following injection of a local anesthetic bolus via the perineural catheter.

2 secondary outcomes

Time for placement
Time frame: 30 minutes
Postoperative pain
Time frame: 1 day

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 4 May 2021.
Background: PubMed 11359219Grant SA, Nielsen KC, Greengrass RA, Steele SM, Klein SM. Continuous peripheral nerve block for ambulatory surgery. Reg Anesth Pain Med. 2001 May-Jun;26(3):209-14. doi: 10.1053/rapm.2001.22256.
Background: PubMed 19920423Mariano ER, Cheng GS, Choy LP, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Lee DK, Maldonado RC, Ilfeld BM. Electrical stimulation versus ultrasound guidance for popliteal-sciatic perineural catheter insertion: a randomized controlled trial. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):480-5. doi: 10.1097/AAP.0b013e3181ada57a.
Background: PubMed 19710219Mariano ER, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Abrams RA, Meunier MJ, Maldonado RC, Ferguson EJ, Ilfeld BM. Ultrasound guidance versus electrical stimulation for infraclavicular brachial plexus perineural catheter insertion. J Ultrasound Med. 2009 Sep;28(9):1211-8. doi: 10.7863/jum.2009.28.9.1211.
Background: PubMed 20700680Mariano ER, Loland VJ, Sandhu NS, Bishop ML, Lee DK, Schwartz AK, Girard PJ, Ferguson EJ, Ilfeld BM. Comparative efficacy of ultrasound-guided and stimulating popliteal-sciatic perineural catheters for postoperative analgesia. Can J Anaesth. 2010 Oct;57(10):919-26. doi: 10.1007/s12630-010-9364-7. Epub 2010 Aug 11.

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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.

Edward R Mariano, MD, MAS principal investigator

VA Palo Alto Health Care System (VAPAHCS)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Proximal placement, Short axis ultrasound and Long axis in people with Pain, Postoperative, run by VA Palo Alto Health Care 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 3 inclusion and 10 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 4 May 2021. 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?

Onset time of sensory anesthesia (time frame: 30 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 NCT01459523, which also lists 4 linked publications.

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 4 May 2021.