- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04451642
A Retrospective Clinical Registry of Peripheral Nerve Block
A Retrospective Clinical Registry of Peripheral Nerve Block: Current Practice and Complications
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zaragoza, Spain, 50012
- Hospital Universitario Miguel Servet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Peripheral nerve block Group
Every patient scheduled during 2011-2019 for the surgery needed a peripheral nerve block were enrolled.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral nerve block
Time Frame: During procedure
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This primary outcome is the type of peripheral nerve block performed
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During procedure
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Incidence and frequency of Serious Adverse Events (SAE)
Time Frame: From performing the peripheral nerve block to 1-year follow-up
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This primary outcome is the incidence, frequency and severity of Serious Adverse Events (SAE) as assessed by CTCAE v4.0 after peripheral nerve block.
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From performing the peripheral nerve block to 1-year follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and frequency of Postoperative neurological complications (PONC)
Time Frame: From performing the peripheral nerve block to 1-year follow-up
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This secondary outcome is the incidence, frequency and severity of Postoperative neurological complications (PONC) as assessed by CTCAE v4.0 after peripheral nerve block.
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From performing the peripheral nerve block to 1-year follow-up
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Local anesthetic used in peripheral nerve block
Time Frame: During procedure
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Local anesthetic type (FDA drug) used in peripheral nerve block performance
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During procedure
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Local anesthetic dose used in peripheral nerve block
Time Frame: During procedure
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Local anesthetic dose (mg) used in peripheral nerve block performance
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During procedure
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Local anesthetic volume used in peripheral nerve block
Time Frame: During procedure
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Local anesthetic volume (ml) used in peripheral nerve block performance
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During procedure
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Nerve location technique used in peripheral nerve block
Time Frame: During procedure
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Type of nerve location technique (ultrasound, nerve stimulator or paresthesia techinique) used in peripheral nerve block performance
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During procedure
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Peripheral nerve block operator
Time Frame: During procedure
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Anesthesiologist operator of peripheral nerve block (attending or trainee).
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During procedure
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pablo Oliver Forniés, MD, Hospital Miguel Servet
Publications and helpful links
General Publications
- 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.
- Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.
- Singh A, Kelly C, O'Brien T, Wilson J, Warner JJ. Ultrasound-guided interscalene block anesthesia for shoulder arthroscopy: a prospective study of 1319 patients. J Bone Joint Surg Am. 2012 Nov 21;94(22):2040-6. doi: 10.2106/JBJS.K.01418.
- Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, Bouaziz H, Samii K. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline Service. Anesthesiology. 2002 Nov;97(5):1274-80. doi: 10.1097/00000542-200211000-00034. Erratum In: Anesthesiology. 2003 Feb;98(2):595. Mercier Frederic [corrected to Mercier Frederic J].
- Bomberg H, Wetjen L, Wagenpfeil S, Schope J, Kessler P, Wulf H, Wiesmann T, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Burkle H, Sessler DI, Volk T. Risks and Benefits of Ultrasound, Nerve Stimulation, and Their Combination for Guiding Peripheral Nerve Blocks: A Retrospective Registry Analysis. Anesth Analg. 2018 Oct;127(4):1035-1043. doi: 10.1213/ANE.0000000000003480.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- POF-LEV-2019-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
- To contact to Study Principal Investigator.
- To provide to Study Principal Investigator a request to explain the reason to access to IPD study.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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