A Retrospective Clinical Registry of Peripheral Nerve Block

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451642
• Other study ID #: POF-LEV-2019-01
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: November 30, 2019

Study information

• Verified date: June 2020
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13816
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Block
• Postoperative Complications
• Regional Anesthesia

Intervention

Procedure:
• Peripheral nerve block
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria Aragón	Hospital Miguel Servet

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. Erratum in: Anesthesiology. 2003 Feb;98(2):595. Mercier Frédéric [corrected to Mercier Frédéric J]. — View Citation

Bomberg H, Wetjen L, Wagenpfeil S, Schöpe J, Kessler P, Wulf H, Wiesmann T, Standl T, Gottschalk A, Döffert J, Hering W, Birnbaum J, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Bürkle 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral nerve block	This primary outcome is the type of peripheral nerve block performed	During procedure
Primary	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	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
Secondary	Local anesthetic used in peripheral nerve block	Local anesthetic type (FDA drug) used in peripheral nerve block performance	During procedure
Secondary	Local anesthetic dose used in peripheral nerve block	Local anesthetic dose (mg) used in peripheral nerve block performance	During procedure
Secondary	Local anesthetic volume used in peripheral nerve block	Local anesthetic volume (ml) used in peripheral nerve block performance	During procedure
Secondary	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
Secondary	Peripheral nerve block operator	Anesthesiologist operator of peripheral nerve block (attending or trainee).	During procedure