NCT02200016

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

July 23, 2014

Last Update Submit

June 10, 2015

Conditions

Postoperative PainRegional Anesthesia

Keywords

Postoperative painRegional anesteshiaNerve cathetersSciatic nerve catheters

Outcome Measures

Primary Outcomes (1)

  • Frequency of nerve catheter displacement

    48 hours after catheter placement

Secondary Outcomes (4)

  • Opioid comsumption

    Within first 48 hours postoperatively

  • Number of rescue blocks

    Within 48 hours postoperatively

  • Postoperativ pain after local anesthetic injection via sciatic nerve catheter

    Within 48 hours postoperatively

  • MR evaluated distribution of local anesthetic after injection MR-contrast

    48 hours after catheter placement

Study Arms (2)

SAX

EXPERIMENTAL

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

Procedure: Ultrasound guided short axis (SAX) placement of sciatic nerve cathetersDevice: B Braun Contiplex S catheter

LAX

ACTIVE COMPARATOR

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

Procedure: Ultrasound guided long axis (LAX) placement of sciatic nerve cathetersDevice: B Braun Contiplex S catheter

Interventions

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

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

SAX
Ultrasound guided long axis (LAX) placement of sciatic nerve cathetersPROCEDURE

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

LAX
B Braun Contiplex S catheterDEVICE
LAXSAX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

Location

Related Publications (11)

  • 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.

    PMID: 11916811BACKGROUND

  • 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.

    PMID: 14570643BACKGROUND

  • 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.

    PMID: 22005661BACKGROUND

  • 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.

    PMID: 23269720BACKGROUND

  • 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.

    PMID: 24310051BACKGROUND

  • 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.

    PMID: 23748198BACKGROUND

  • 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.

    PMID: 15019387BACKGROUND

  • 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.

    PMID: 19243320BACKGROUND

  • 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.

    PMID: 21519311BACKGROUND

  • 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.

    PMID: 24432160BACKGROUND

  • 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.

    PMID: 27440634DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

July 23, 2014

First Posted

July 25, 2014

Study Start

November 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

DK(1)