Coiling of Echogenic Sciatic Nerve Perineurial Catheters with Integral Stylet

NCT06568510 | Completed

• 1 other identifier: 342 (date:9/05/2024)
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Coiling of perineurial catheters under the sciatic nerve and examination of catheters position through ultrasound imaging 36 hours postoperatively.

Conditions

Pain; Trauma

Keywords

Prineural catheter; Ultrasound; Sciatic nerve

Outcome Measures

Primary Outcomes (1)

• Rate of correct placement of coiled perineural catheters under the sciatic nerve

  A Tuohy needle is placed underneath the sciatic nerve. Then, a catheter is headed out through the curved tip of the Tuohy needle and coils underneath the sciatic nerve. Catheter's position was assessed after 36 hour postoperatively. Catheters tip internal displacement was assessed after contact with the nerve of 3 cc of local anesthetic injecting via the catheter (maximum three tines).

  10 minutes

Study Arms (1)

Patients with continuous sciatic nerve block

Patients were placed in the lateral position (with the injured leg uppermost) and a US-guided sciatic nerve block was performed under aseptic conditions . The sciatic nerve was visualized at the upper third of the posterior thigh (short axis view) and a Tuohy needle (21 G × 10 mm, was inserted in a lateral to medial direction. The needle was placed underneath the sciatic nerve and 10 ml of ropivacaine (0.1%) were injected. A perineural catheter (with retracted integral stylet by 6 cm) was then threaded through the needle tip and coiled behind the sciatic nerve. Confirmation of correct catheter tip placement was defined as adequate spread and contact of ropivacaine injectate (3 ml, 0.1%) with the sciatic nerve

Procedure: Continuous peripheral nerve block

Interventions

Continuous peripheral nerve block PROCEDURE

A perineurial catheter is placed to a nerve structure through a Touchy needle

Patients with continuous sciatic nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Orthopaedic patients with Tibial fractures

You may not qualify if:

• Patients with infection in the sub gluteal region.
• Allergies to local aesthetics
• Patients refusal to consent for the nerve block
• Neurological disorders
• Pregnancy

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS

Athens, Attica, 15562, Greece

Location

Related Publications (2)

• Saranteas T, Poulogiannopoulou E, Ntalamagka G, Skaligkou P, Giasafaki M, Papadimos T. Perineural coiled echogenic catheters with a flexible distal end: A brief technical report. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101341. doi: 10.1016/j.accpm.2023.101341. Epub 2023 Dec 22. No abstract available.

  PMID: 38142867 BACKGROUND

• Saranteas T, Poulogiannopoulou E, Riga M, Panagouli K, Mavrogenis A, Papadimos T. Coiling of echogenic perineural catheters with integral stylet: A proof-of-concept randomized control trial in a sciatic nerve block simulator and a pilot study in orthopaedic-trauma patients. F1000Res. 2024 Dec 2;13:1103. doi: 10.12688/f1000research.155381.2. eCollection 2024.

  PMID: 39639915 DERIVED

Related Links

• doi

MeSH Terms

Conditions

Pain; Wounds and Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mavrogenis Andreas

  Academic teacher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: May 10, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

GR (1)