A Retrospective Clinical Registry of Peripheral Nerve Block

NCT04451642 | Completed

• 1 other identifier: POF-LEV-2019-01
• Study Type: observational
• Target: 13,816
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Block; Regional Anesthesia; Postoperative Complications

Keywords

Regional Anesthesia; Postoperative neurological complications; Ultrasound; Nerve stimulator; Brachial Plexus Block

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Incidence and frequency of Postoperative neurological complications (PONC)

  From performing the peripheral nerve block to 1-year follow-up

• Local anesthetic used in peripheral nerve block

  During procedure

• Local anesthetic dose used in peripheral nerve block

  During procedure

• Local anesthetic volume used in peripheral nerve block

  During procedure

• Nerve location technique used in peripheral nerve block

  During procedure

Study Arms (1)

Peripheral nerve block Group

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

Procedure: Peripheral nerve block

Interventions

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.

Peripheral nerve block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Hospital Miguel Servet: collaborator

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, 50012, Spain

Location

Related Publications (6)

• 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.

  PMID: 31392721 BACKGROUND

• 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.

  PMID: 23172321 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.

  PMID: 12411815 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.

  PMID: 29863605 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.

  PMID: 19604186 BACKGROUND

• 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.

  PMID: 34432155 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pablo Oliver Forniés, MD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: January 1, 2011
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: August 10, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting in July 2021 for 25 years. DOI: 10.1007/s00540-021-02989-7
• 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.

Locations

ES (1)