Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568510
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Coiling of Echogenic Sciatic Nerve Perineurial Catheters with Integral Stylet
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Coiling of Echogenic Perineural Catheters
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coiling of perineurial catheters under the sciatic nerve and examination of catheters position through ultrasound imaging 36 hours postoperatively
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 SonoLongNanoLine PAJUNK Germany was inserted in a lateral to medial direction The needle was placed underneath the sciatic nerve and 10 ml of ropivacaine 01 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 01 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 05 and general anaesthesia A continuous infusion of ropivacaine 8-12 ml 01 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
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 SonoLongNanoLine PAJUNK Germany was inserted in a lateral to medial direction The needle was placed underneath the sciatic nerve and 10 ml of ropivacaine 01 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 01 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 05 and general anaesthesia A continuous infusion of ropivacaine 8-12 ml 01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None