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Completed

NCT Number: NCT04451642

A Retrospective Clinical Registry of Peripheral Nerve Block

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Miguel Servet

Zaragoza, 50012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral nerve block

Procedure

Peripheral nerve block consists of the administration of a local anaesthetic into the nerves to inhibit nerve transmission in a specific part of the body. Ultrasound or Nerve stimulator could be used to locate the peripheral nerve. A needle is placed through the anatomical references to administer local anaesthetic around the peripheral nerve. Single-shot or continuous blocks are performed preoperatively and postoperatively as current practice in the surgery theatre. Using ultrasound, in-plane or out-plane approach could be performed. Peripheral nerve block provides excellent intraoperative and postoperative analgesia decreasing the need for intravenous pain drugs. Interscalene block, supraclavicular block, safene block, femoral block, BRILMA block are different kinds of peripheral nerve block using in the anaesthestic current practice.

Primary outcomes

  1. Peripheral nerve block

    Time frame: During procedure

    This primary outcome is the type of peripheral nerve block performed

  2. Incidence and frequency of Serious Adverse Events (SAE)

    Time frame: 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 outcomes

  1. Incidence and frequency of Postoperative neurological complications (PONC)

    Time frame: 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.

  2. Local anesthetic used in peripheral nerve block

    Time frame: During procedure

    Local anesthetic type (FDA drug) used in peripheral nerve block performance

  3. Local anesthetic dose used in peripheral nerve block

    Time frame: During procedure

    Local anesthetic dose (mg) used in peripheral nerve block performance

  4. Local anesthetic volume used in peripheral nerve block

    Time frame: During procedure

    Local anesthetic volume (ml) used in peripheral nerve block performance

  5. Nerve location technique used in peripheral nerve block

    Time frame: During procedure

    Type of nerve location technique (ultrasound, nerve stimulator or paresthesia techinique) used in peripheral nerve block performance

  6. Peripheral nerve block operator

    Time frame: During procedure

    Anesthesiologist operator of peripheral nerve block (attending or trainee).

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria Aragón

Other

Collaborators

  • Hospital Miguel Servet

Registry information

Official study title

A Retrospective Clinical Registry of Peripheral Nerve Block: Current Practice and Complications

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jun 30, 2020
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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