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| Name | Class |
|---|---|
| Hospital Miguel Servet | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral nerve block Group | Every patient scheduled during 2011-2019 for the surgery needed a peripheral nerve block were enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral nerve block | This primary outcome is the type of peripheral nerve block performed | During procedure |
| Incidence and frequency of Serious Adverse Events (SAE) | This primary outcome is the incidence, frequency and severity of Serious Adverse Events (SAE) as assessed by CTCAE v4.0 after peripheral nerve block. | From performing the peripheral nerve block to 1-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and frequency of Postoperative neurological complications (PONC) | This secondary outcome is the incidence, frequency and severity of Postoperative neurological complications (PONC) as assessed by CTCAE v4.0 after peripheral nerve block. | From performing the peripheral nerve block to 1-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Oliver Forniés, MD | Hospital Miguel Servet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Miguel Servet | Zaragoza | 50012 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31392721 | Background | 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. | |
| 23172321 |
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All collected IPD will be available on file in storage and on the Internet (URL undecided yet) after finishing the data collection for 25 years at the participating site.
Starting in July 2021 for 25 years. DOI: 10.1007/s00540-021-02989-7
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 | Aug 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2020 | Aug 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Local anesthetic used in peripheral nerve block |
Local anesthetic type (FDA drug) used in peripheral nerve block performance |
| During procedure |
| Local anesthetic dose used in peripheral nerve block | Local anesthetic dose (mg) used in peripheral nerve block performance | During procedure |
| Local anesthetic volume used in peripheral nerve block | Local anesthetic volume (ml) used in peripheral nerve block performance | During procedure |
| Nerve location technique used in peripheral nerve block | Type of nerve location technique (ultrasound, nerve stimulator or paresthesia techinique) used in peripheral nerve block performance | During procedure |
| Peripheral nerve block operator | Anesthesiologist operator of peripheral nerve block (attending or trainee). | During procedure |
| 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. |
| 12411815 | Background | 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. |
| 29863605 | Background | 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. |
| 19604186 | Background | 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. |
| 34432155 | Derived | 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. |