Clinical trial NCT04451642: A Retrospective Clinical Registry of Peripheral Nerve Block
Official title: A Retrospective Clinical Registry of Peripheral Nerve Block: Current Practice and Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nerve Block
Regional Anesthesia
Postoperative Complications
Keywords: Regional Anesthesia
Postoperative neurological complications
Ultrasound
Nerve stimulator
Brachial Plexus Block
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Hospital Miguel Servet
First posted: 2020-06-30
Enrollment: 13816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from the current practice of the Anesthesia Department (Division of Regional Anesthesia) at the Hospital Universitario Miguel Servet (HUMS) in Zaragoza, Spain. HUMS provides health care to a population size of about 400000 inhabitants, mostly urban, and more than 200 shoulder and upper extremity surgeries are performed every year.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peripheral nerve block
timeFrame: During procedure
measure: Incidence and frequency of Serious Adverse Events (SAE)
timeFrame: From performing the peripheral nerve block to 1-year follow-up
Secondary outcomes:
measure: Incidence and frequency of Postoperative neurological complications (PONC)
timeFrame: From performing the peripheral nerve block to 1-year follow-up
measure: Local anesthetic used in peripheral nerve block
timeFrame: During procedure
measure: Local anesthetic dose used in peripheral nerve block
timeFrame: During procedure
measure: Local anesthetic volume used in peripheral nerve block
timeFrame: During procedure
measure: Nerve location technique used in peripheral nerve block
timeFrame: During procedure
measure: Peripheral nerve block operator
timeFrame: During procedure
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Miguel Servet
name: Pablo Oliver Forniés, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x.
citation: Oliver-Fornies P, Ortega Lahuerta JP, Gomez Gomez R, Gonzalo Pellicer I, Herranz Andres P, Sancho-Saldana A. Postoperative neurological complications after brachial plexus block: a retrospective study conducted at a teaching hospital. J Anesth. 2021 Dec;35(6):844-853. doi: 10.1007/s00540-021-02989-7. Epub 2021 Aug 25.