AzTrials
AzTrials

Postoperative PainPhase 4NCT02200016

Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery

A Phase 4 study testing Ultrasound guided short axis (SAX) placement of sciatic nerve catheters, Ultrasound guided long axis (LAX) placement of sciatic nerve catheters and B Braun Contiplex S catheter in people with Postoperative Pain and Regional Anesthesia, run by Kolding Sygehus at 1 site in Denmark.

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

Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A randomized controlled double blinded MRI study comparing long versus short axis catheter placement. Which procedure for insertion of nerve catheters for postoperative pain after major foot and ankle surgery is the best Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain, Regional Anesthesia
What is being tested?
Ultrasound guided short axis (SAX) placement of sciatic nerve catheters, Ultrasound guided long axis (LAX) placement of sciatic nerve catheters and B Braun Contiplex S catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteDenmark
Study dates
Nov 2014to May 2015
Phase
Phase 4
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

  • Age ≥ 18 y.
  • Major foot and ankle surgery postoperativ pain treatment with sciatic nerve catheter r
  • Written and informed concent

Who cannot join

  • Patient uanble to cooperate
  • Patients not speaking and understanding Danish or English
  • Patiens in immunosuppresive treatment
  • Patienter with neuropathys in lower extremities
  • Allergies to the in the protocole listes medicines
  • A daily opoid intake
  • Pregnant women
  • Patients not meeting MR-criterias (metal, claustofobia...)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Anesthesia, Aarhus University Hospital

    Aarhus, Region Midt, 8000

Other trials in Denmark

About this study

Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A randomized controlled double blinded MRI study comparing long versus short axis catheter placement. Which procedure for insertion of nerve catheters for postoperative pain after major foot and ankle surgery is the best

Being tested
Ultrasound guided short axis (SAX) placement of sciatic nerve catheters, Ultrasound guided long axis (LAX) placement of sciatic nerve catheters, B Braun Contiplex S catheter
Keywords
Postoperative pain, Regional anesteshia, Nerve catheters, Sciatic nerve catheters
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Ultrasound guided short axis (SAX) placement of sciatic nerve cathetersProcedure or surgery

    Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the short axis of the sciatic nerve behind the knee.

  • Ultrasound guided long axis (LAX) placement of sciatic nerve cathetersProcedure or surgery

    Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the long axis of the sciatic nerve behind the knee.

  • B Braun Contiplex S catheterDevice

Study groups in NCT02200016
Study groupRoleWhat they receive
SAXExperimentalUltrasound guided short axis (SAX) placement of sciatic nerve catheters
Receives: Procedure: Ultrasound guided short axis (SAX) placement of sciatic nerve catheters; Device: B Braun Contiplex S catheter
LAXActive comparatorUltrasound guided long axis (LAX) placement of sciatic nerve catheters
Receives: Procedure: Ultrasound guided long axis (LAX) placement of sciatic nerve catheters; Device: B Braun Contiplex S catheter

What is being measured

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

  1. Frequency of nerve catheter displacement

    Measured: 48 hours after catheter placement

Secondary outcomes (4)

  1. Opioid comsumption

    Measured: Within first 48 hours postoperatively

  2. Number of rescue blocks

    Measured: Within 48 hours postoperatively

  3. Postoperativ pain after local anesthetic injection via sciatic nerve catheter

    Measured: Within 48 hours postoperatively

  4. MR evaluated distribution of local anesthetic after injection MR-contrast

    Measured: 48 hours after catheter placement

Timeline

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

  1. First posted25 Jul 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02200016
Sponsor's protocol ID
2014-000707-28
Other IDs
2014
Status last verified
Jun 2015
First submitted
23 Jul 2014
Last updated
11 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • di Benedetto P, Casati A, Bertini L, Fanelli G, Chelly JE. Postoperative analgesia with continuous sciatic nerve block after foot surgery: a prospective, randomized comparison between the popliteal and subgluteal approaches. Anesth Analg. 2002 Apr;94(4):996-1000, table of contents. doi: 10.1097/00000539-200204000-00041.

    PubMed 11916811

  • White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4.

    PubMed 14570643

  • Tran DQ, Dugani S, Pham K, Al-Shaafi A, Finlayson RJ. A randomized comparison between subepineural and conventional ultrasound-guided popliteal sciatic nerve block. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):548-52. doi: 10.1097/AAP.0b013e318235f566.

    PubMed 22005661

  • Mariano ER, Kim TE, Funck N, Walters T, Wagner MJ, Harrison TK, Giori N, Woolson S, Ganaway T, Howard SK. A randomized comparison of long-and short-axis imaging for in-plane ultrasound-guided femoral perineural catheter insertion. J Ultrasound Med. 2013 Jan;32(1):149-56. doi: 10.7863/jum.2013.32.1.149.

    PubMed 23269720

  • Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.

    PubMed 24310051

  • Marhofer D, Marhofer P, Triffterer L, Leonhardt M, Weber M, Zeitlinger M. Dislocation rates of perineural catheters: a volunteer study. Br J Anaesth. 2013 Nov;111(5):800-6. doi: 10.1093/bja/aet198. Epub 2013 Jun 7.

    PubMed 23748198

  • Niemi-Murola L, Krootila K, Kivisaari R, Kangasmaki A, Kivisaari L, Maunuksela EL. Localization of local anesthetic solution by magnetic resonance imaging. Ophthalmology. 2004 Feb;111(2):342-7. doi: 10.1016/j.ophtha.2003.05.026.

    PubMed 15019387

  • Compere V, Rey N, Baert O, Ouennich A, Fourdrinier V, Roussignol X, Beccari R, Dureuil B. Major complications after 400 continuous popliteal sciatic nerve blocks for post-operative analgesia. Acta Anaesthesiol Scand. 2009 Mar;53(3):339-45. doi: 10.1111/j.1399-6576.2008.01849.x.

    PubMed 19243320

  • Ilfeld BM, Sandhu NS, Loland VJ, Madison SJ, Suresh PJ, Mariano ER, Bishop ML, Schwartz AK, Lee DK. Ultrasound-guided (needle-in-plane) perineural catheter insertion: the effect of catheter-insertion distance on postoperative analgesia. Reg Anesth Pain Med. 2011 May-Jun;36(3):261-5. doi: 10.1097/AAP.0b013e31820f3b80.

    PubMed 21519311

  • Zacchino M, Almolla J, Canepari E, Merico V, Calliada F. Use of ultrasound-magnetic resonance image fusion to guide sacroiliac joint injections: a preliminary assessment. J Ultrasound. 2013 Jul 31;16(3):111-8. doi: 10.1007/s40477-013-0028-7. eCollection 2013 Jul 31.

    PubMed 24432160

  • Hauritz RW, Pedersen EM, Linde FS, Kibak K, Borglum J, Bjoern S, Bendtsen TF. Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery: a randomized controlled double-blinded magnetic resonance imaging study. Br J Anaesth. 2016 Aug;117(2):220-7. doi: 10.1093/bja/aew172.

    PubMed 27440634

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ultrasound guided short axis (SAX) placement of sciatic nerve catheters, Ultrasound guided long axis (LAX) placement of sciatic nerve catheters and B Braun Contiplex S catheter in people with Postoperative Pain and Regional Anesthesia, run by Kolding Sygehus at 1 site in Denmark.

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 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 11 Jun 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Frequency of nerve catheter displacement (time frame: 48 hours after catheter placement). 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 NCT02200016, which also lists 11 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 11 Jun 2015.

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