Coiling of Echogenic Sciatic Nerve Perineurial Catheters with Integral Stylet

NCT ID: NCT06568510

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-10

Study Completion Date

2024-07-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Trauma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Continuous peripheral nerve block

Intervention Type PROCEDURE

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

Interventions

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Continuous peripheral nerve block

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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THEODOSIOS SARANTEAS

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mavrogenis Andreas

Role: PRINCIPAL_INVESTIGATOR

Academic teacher

Locations

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Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 38142867 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39639915 (View on PubMed)

Related Links

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Other Identifiers

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342 (date:9/05/2024)

Identifier Type: -

Identifier Source: org_study_id

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