Coiling of Echogenic Sciatic Nerve Perineurial Catheters With Integral Stylet

Coiling of Echogenic Perineural Catheters.

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

Study Overview

• Status: Completed
• Conditions: Pain; Trauma
• Intervention / Treatment: Procedure: Continuous peripheral nerve block

Detailed Description

To assess procedural effectiveness of the preferred coiling technique (method B), a pilot study was performed. Straight perineural catheters with coiled distal ends behind the sciatic nerve were examined in 25 patients who had sustained tibia fractures.

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, SonoLong/NanoLine, PAJUNK, Germany) 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) (SonoLong Sono, PAJUNK, Germany) 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 (Figure 2C). If the distribution of the local anaesthetic (LA) could not be visualized on the first infusion, 2 additional injections were performed until the distribution was clearly seen. If LA spread could not be visually confirmed, or if, when confirmed, LA did not come in contact with the sciatic nerve, the case was excluded.

Subcutaneous tunneling (4 cm long) and placement of a transparent adhesive dressing were used to secure the catheter. All sciatic nerve blocks were followed by an adductor canal block (10 ml of ropivacaine 0.5%) and general anaesthesia. A continuous infusion of ropivacaine (8-12 ml, 0.1%) was commenced and a combination of oxycodone 5 mg with paracetamol 325 mg was provided on an as-needed basis after surgery.

All nerve blocks were assessed and data were collected in the post-anaesthetic care unit, and every 12 hours thereafter until 36 hours postoperatively from members of acute pain service (APS) team not participating in the study.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 15562
      • Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Orthopaedic patients with Tibial fractures

Description

Inclusion Criteria: Orthopaedic patients with Tibia fractures

-

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Principal Investigator: Mavrogenis Andreas, Academic teacher

Publications and helpful links

General Publications

• 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Sciatic nerve; Prineural catheter
• Other Study ID Numbers: 342 (date:9/05/2024)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No