A Retrospective Clinical Registry of Peripheral Nerve Block

Completed

• Conditions: Postoperative Complications; Regional Anesthesia; Nerve Block
• Interventions: Procedure: Peripheral nerve block

• Registration Number: NCT04451642
• Lead Sponsor: Instituto de Investigación Sanitaria Aragón

Brief Summary

Locorregional anaesthesia have been increased its role in different kind of surgeries, alone or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been increased their importance in locoregional anaesthesia. They provide excellent intraoperative and postoperative analgesia, decreasing the need for intravenous opioids which increase postoperative nausea and vomiting which may prolong hospital stay.

The primary study objective is to analyze retrospectively the use of peripheral nerve blocks in the current practice of a specialized regional anaesthesia division.

This is an observational, retrospective and unicenter study. 1346 patients scheduled for the surgery needed a peripheral nerve block were enrolled.

Detailed Description

Locorregional anaesthesia have been increased its role in different kind of surgeries, alone or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been increased their importance in locoregional anaesthesia. They provide excellent intraoperative and postoperative analgesia, decreasing the need for intravenous opioids which increase postoperative nausea and vomiting which may prolong hospital stay.

However, peripheral nerve blocks may be associated with postoperative complications, especially neurological ones. Classically, interscalene brachial plexus block produced a 100% incidence of phrenic nerve paralysis with resultant pulmonary compromise. Little literature has published a following of complications.

The primary study objective is to analyze retrospectively the use of peripheral nerve blocks in the current practice of a specialized regional anaesthesia division. The secondary objectives are assessed the patients characteristics of our sample, local anaesthetic dose used, the peripheral nerve block operator, the nerve location technique, the surgery and the complication rate after peripheral nerve block.

This is an observational, retrospective and unicenter study. 1346 patients scheduled for the surgery needed a peripheral nerve block were enrolled.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13816

Inclusion Criteria

• Every patient who needs a peripheral nerve block performed by Anestesia Department.

Exclusion Criteria

• Patient refusal of peripheral nerve block.
• Known allergy to amide local anaesthetic drugs
• Absolute contraindications to perform a peripheral nerve block as coagulopathy, active infection at the block site or severe respiratory background.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peripheral nerve block Group	Peripheral nerve block	Every patient scheduled during 2011-2019 for the surgery needed a peripheral nerve block were enrolled.

Primary Outcome Measures

Name	Time	Method
Peripheral nerve block	During procedure	This primary outcome is the type of peripheral nerve block performed
Incidence and frequency of Serious Adverse Events (SAE)	From performing the peripheral nerve block to 1-year follow-up	This primary outcome is the incidence, frequency and severity of Serious Adverse Events (SAE) as assessed by CTCAE v4.0 after peripheral nerve block.

Secondary Outcome Measures

Name	Time	Method
Incidence and frequency of Postoperative neurological complications (PONC)	From performing the peripheral nerve block to 1-year follow-up	This secondary outcome is the incidence, frequency and severity of Postoperative neurological complications (PONC) as assessed by CTCAE v4.0 after peripheral nerve block.
Local anesthetic dose used in peripheral nerve block	During procedure	Local anesthetic dose (mg) used in peripheral nerve block performance
Local anesthetic used in peripheral nerve block	During procedure	Local anesthetic type (FDA drug) used in peripheral nerve block performance
Peripheral nerve block operator	During procedure	Anesthesiologist operator of peripheral nerve block (attending or trainee).
Local anesthetic volume used in peripheral nerve block	During procedure	Local anesthetic volume (ml) used in peripheral nerve block performance
Nerve location technique used in peripheral nerve block	During procedure	Type of nerve location technique (ultrasound, nerve stimulator or paresthesia techinique) used in peripheral nerve block performance

Trial Locations

Locations (1)

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain