Clinical trial NCT02200016: Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Regional Anesthesia
Keywords: Postoperative pain
Regional anesteshia
Nerve catheters
Sciatic nerve catheters
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2014-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


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...)

Primary outcomes:
measure: Frequency of nerve catheter displacement
timeFrame: 48 hours after catheter placement
Secondary outcomes:
measure: Opioid comsumption
timeFrame: Within first 48 hours postoperatively
measure: Number of rescue blocks
timeFrame: Within 48 hours postoperatively
measure: Postoperativ pain after local anesthetic injection via sciatic nerve catheter
timeFrame: Within 48 hours postoperatively
measure: MR evaluated distribution of local anesthetic after injection MR-contrast
timeFrame: 48 hours after catheter placement
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Anesthesia, Aarhus University Hospital
state: Region Midt
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.