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

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200016
• Other study ID #: 2014-000707-28
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2014
• Last updated: June 10, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Kolding Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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...)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

Procedure:
• 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.
• 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.

Device:
• B Braun Contiplex S catheter

Locations

Country	Name	City	State
Denmark	Department of Anesthesia, Aarhus University Hospital	Aarhus	Region Midt

Sponsors (2)

Lead Sponsor	Collaborator
Kolding Sygehus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (10)

Compère 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Niemi-Murola L, Krootila K, Kivisaari R, Kangasmäki A, Kivisaari L, Maunuksela EL. Localization of local anesthetic solution by magnetic resonance imaging. Ophthalmology. 2004 Feb;111(2):342-7. — View 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. — View 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):1303-9. Erratum in: Anesth Analg. 2003 Dec;97(6):1557. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of nerve catheter displacement		48 hours after catheter placement	No
Secondary	Opioid comsumption		Within first 48 hours postoperatively	No
Secondary	Number of rescue blocks		Within 48 hours postoperatively	No
Secondary	Postoperativ pain after local anesthetic injection via sciatic nerve catheter		Within 48 hours postoperatively	No
Secondary	MR evaluated distribution of local anesthetic after injection MR-contrast		48 hours after catheter placement	No