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

NCT ID: NCT02200016

Last Updated: 2015-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Regional Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SAX

Ultrasound guided short axis (SAX) placement of sciatic nerve catheters

Group Type EXPERIMENTAL

Ultrasound guided short axis (SAX) placement of sciatic nerve catheters

Intervention Type PROCEDURE

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

B Braun Contiplex S catheter

Intervention Type DEVICE

LAX

Ultrasound guided long axis (LAX) placement of sciatic nerve catheters

Group Type ACTIVE_COMPARATOR

Ultrasound guided long axis (LAX) placement of sciatic nerve catheters

Intervention Type PROCEDURE

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 catheter

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound guided short axis (SAX) placement of sciatic nerve catheters

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

Intervention Type PROCEDURE

Ultrasound guided long axis (LAX) placement of sciatic nerve catheters

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

Intervention Type PROCEDURE

B Braun Contiplex S catheter

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Kolding Sygehus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rasmus Wulff Hauritz

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesia, Aarhus University Hospital

Aarhus, Region Midt, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11916811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14570643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22005661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23269720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24310051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23748198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15019387 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19243320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21519311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24432160 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27440634 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-000707-28

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.