Ultrasound-guided Block of the Supraclavicular Nerves in Clavicular Fractures

NCT04685291 | Completed

• 1 other identifier: 1.0 / 10.12.2020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

A Clavicular fractures (CF) is uncomfortable for the affected patients because the fragments are often strongly displaced by the muscles attached to them and the bony fragments move painfully with every movement of the shoulder. In emergency departments (ED), so far CF has been tackled with drugs that are taken by mouth or injected into a vein. This type of pain management has many side effects since these painkillers act systemically. The aim of the study is to investigate the effectiveness of pain relief in CF to be operated using regional anaesthesia. For this purpose, the supraclavicular nerves (SCN), which run directly under the skin of the neck, will be located using an ultrasound device (US). Under US-guidance the injection needle approaches the SCN and 2-3 millilitres of local aesthetic (LA) are injected around the nerves. The pain relief may last 12 up to 24 hours, which bridges the time until the operation (OP). In order to compare this procedure, CF-patients will be divided into two groups, of which the control group (21) will be treated with painkillers in the conventional manner and the intervention group (21) will receive the US-guided block of the SCN. With the small amount of LA injected, adverse events (AE) are very rare. Nevertheless, the puncture in the side of the neck may cause bruises at the site of the injection or uncomfortable, spreading pain. Systemic side effects are unlikely. In the intervention group, the investigators expect a nearly complete pain relief up to the operation than with conventional pain therapy and a lower rate of side effects than with systemic administration of painkillers.

Conditions

Clavicular Fracture; Pain, Acute

Keywords

ultrasound-guided regional anesthesia; Clavicular fracture; Emergency Department; pain management

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale

  The numerical rating scale (NRS) is one of the most widely used pain rating scales. It ranges from zero to ten, with zero being no pain and ten being the worst possible pain. The measurement of the NRS is achieved using the patient evaluation sheet.

  within the first 24 hours after ED-Admission or until the operation

Secondary Outcomes (4)

• Painkillers in milligrams until surgery

  within the first 24 hours after ED-Admission or until the operation

• Painkillers in milligrams after surgery

  within the first 24 hours after ED-Admission after the operation

• Patient Questionnaire

  Within the first 24 hours after ED-Admission or after operation

• Incidence of side effects

  within the first 24 hours after ED-Admission

Study Arms (2)

Group 1: Control

ACTIVE COMPARATOR

Systemic conventional pain management. Adult patients with acute fractures of the clavicle, who are scheduled to have internal fixation of the fracture within the next 24 hours receive oral and intravenous pain management.

Drug: Conventional pain management

Group 2: Nerve Block

ACTIVE COMPARATOR

Adult patients with acute fractures of the clavicle, who are scheduled for an internal fixation of the fracture within the next 24 hours will receive an ultrasound-guided block of the supraclavicular nerves using a maximum of 3 ml of a long-acting local anesthetic. The injection is carried out directly in the emergency department following a sonographic or radiological diagnosis.

Procedure: Ultrasound-guided block of the supraclavicular nerves

Interventions

Ultrasound-guided block of the supraclavicular nerves PROCEDURE

The supraclavicular nerves (SCN) arise from the 3rd and 4th roots of the spinal nerves. After emerging from the spine, they run at the rear margin of the sternocleidomastoid muscle and divide into their three terminal branches. With a high-resolution Ultrasound (US)-probe they can be visualized as a grape-like structure under the skin. At this location, patient's skin is disinfected and covered with a sterile perforated blanket. The US-probe is covered with a sterile sheath. The patient is positioned as comfortably as possible so that the broken clavicle is not mobilized. SCN are shown by US and a 0.5 mm needle is advanced through the patient's skin in order to direct it to the nerves under US-guidance. Both the nerves and the needle are permanently visualized. As soon as the needle tip is placed next to the SCN, 2-3 millilitres of a long-acting LA are injected. The distribution of the LA around the nerves is controlled.

Group 2: Nerve Block

Conventional pain management DRUG

* oral pain medication in patients younger than 70 years: Ibuprofen 400mg (1-1-1) AND Metamizole 500mg (max. 2 tbl. every 6 hours) * oral pain medication in patients older than or equal 70 years: Acemetacin 60mg (1-1-1) AND Metamizole 500mg (max. 2 tbl. every 6 hours) * Rescue analgesic medication for all patients: oxycodone hydrochlorid (drops) p.o. (10 mg/ml) 0.1mg/kg p.o. hour * In the ED Rescue analgesic medication for all patients: Fentanyl 50mcg i.v. (max. 200mcg/hour)

Group 1: Control

Eligibility Criteria

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

You may qualify if:

• adult ED-patients with sonographic and / or radiologically diagnosed clavicular fracture, who are scheduled for operation within the next 24 hours
• older then 18 years
• no known allergies to local anesthetic drugs

You may not qualify if:

• refusal of the procedure by the patient
• infection at the site of possible injection of local anaesthetics
• known allergies against local anaesthetics
• inability of consent or no carer

Sponsors & Collaborators

• Eckehart SCHÖLL: lead

Study Sites (1)

Merian Iselin Klinik

Basel, 4009, Switzerland

Location

Related Publications (6)

• Tran DQ, Tiyaprasertkul W, Gonzalez AP. Analgesia for clavicular fracture and surgery: a call for evidence. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):539-43. doi: 10.1097/AAP.0000000000000012.

  PMID: 24121609 BACKGROUND

• Shanthanna H. Ultrasound guided selective cervical nerve root block and superficial cervical plexus block for surgeries on the clavicle. Indian J Anaesth. 2014 May;58(3):327-9. doi: 10.4103/0019-5049.135050.

  PMID: 25024480 BACKGROUND

• Ueshima H, Otake H. Successful clavicle fracture surgery performed under selective supraclavicular nerve block using the new subclavian approach. JA Clin Rep. 2016;2(1):34. doi: 10.1186/s40981-016-0061-6. Epub 2016 Nov 8.

  PMID: 29492429 BACKGROUND

• Valdes-Vilches LF, Sanchez-del Aguila MJ. Anesthesia for clavicular fracture: selective supraclavicular nerve block is the key. Reg Anesth Pain Med. 2014 May-Jun;39(3):258-9. doi: 10.1097/AAP.0000000000000057. No abstract available.

  PMID: 24747317 BACKGROUND

• Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.

  PMID: 19602964 BACKGROUND

• Wadlund DL. Local Anesthetic Systemic Toxicity. AORN J. 2017 Nov;106(5):367-377. doi: 10.1016/j.aorn.2017.08.015.

  PMID: 29107256 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Emergencies; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Eckehart Schöll, MD

  Merian Iselin Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The comparator group will get systemic conventional pain management. Pain management using placebo would be harmful in patients with clavicular fractures. If these patients will have a severely dislocated fracture, they will be scheduled to have internal fixation of the fracture within the next 24 hours. They will receive oral and intravenous pain management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Emergency Department

Model Details: Prospective randomised single centre study

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 28, 2020
• Study Start: April 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 6, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)