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

Primary Purpose

Postoperative Pain, Regional Anesthesia

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

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

About this trial

This is an interventional diagnostic trial for Postoperative Pain focused on measuring Postoperative pain, Regional anesteshia, Nerve catheters, Sciatic nerve catheters

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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...)

Sites / Locations

Department of Anesthesia, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAX

LAX

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency of nerve catheter displacement

Secondary Outcome Measures

Opioid comsumption

Number of rescue blocks

Postoperativ pain after local anesthetic injection via sciatic nerve catheter

MR evaluated distribution of local anesthetic after injection MR-contrast

Full Information

NCT ID

NCT02200016

First Posted

July 23, 2014

Last Updated

June 10, 2015

Sponsor

Kolding Sygehus

Collaborators

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02200016

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kolding Sygehus

Collaborators

Aarhus University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Regional Anesthesia

Keywords

Postoperative pain, Regional anesteshia, Nerve catheters, Sciatic nerve catheters

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAX

Arm Type

Experimental

Arm Description

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

Arm Title

LAX

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Device

Intervention Name(s)

B Braun Contiplex S catheter

Primary Outcome Measure Information:

Title

Frequency of nerve catheter displacement

Time Frame

48 hours after catheter placement

Secondary Outcome Measure Information:

Title

Opioid comsumption

Time Frame

Within first 48 hours postoperatively

Title

Number of rescue blocks

Time Frame

Within 48 hours postoperatively

Title

Postoperativ pain after local anesthetic injection via sciatic nerve catheter

Time Frame

Within 48 hours postoperatively

Title

MR evaluated distribution of local anesthetic after injection MR-contrast

Time Frame

48 hours after catheter placement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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...)

Facility Information:

Facility Name

Department of Anesthesia, Aarhus University Hospital

City

Aarhus

State/Province

Region Midt

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

11916811

Citation

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.

Results Reference

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PubMed Identifier

14570643

Citation

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. Erratum In: Anesth Analg. 2003 Dec;97(6):1557.

Results Reference

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PubMed Identifier

22005661

Citation

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.

Results Reference

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PubMed Identifier

23269720

Citation

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.

Results Reference

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PubMed Identifier

24310051

Citation

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.

Results Reference

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PubMed Identifier

23748198

Citation

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.

Results Reference

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PubMed Identifier

15019387

Citation

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.

Results Reference

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PubMed Identifier

19243320

Citation

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.

Results Reference

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PubMed Identifier

21519311

Citation

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.

Results Reference

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PubMed Identifier

24432160

Citation

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.

Results Reference

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PubMed Identifier

27440634

Citation

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.

Results Reference

derived

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

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