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PainNCT04067024

Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker

A study testing Local anesthesia made by surgeon and Regional anesthesia group in people with Pain and Pacemaker Ddd, run by Erasme University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pacemakers are currently placed at the Erasmus Hospital under local anesthesia performed by the surgeon, and the amount of local anesthetic agents sometimes reach the maximum permitted doses, with a risk of systemic toxicity. Moreover, these patients often present an associated conduction block. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Pacemaker Ddd
What is being tested?
Local anesthesia made by surgeon and Regional anesthesia group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteBelgium
Study dates
18 Jan 2017to 7 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women and men > 18 years of age
  • Patients scheduled for the implantation of a pace-maker

Who cannot join

  • Patients refusing to sign the consent
  • Patients included in another protocol within 3 months
  • Pregnant or breastfeeding patients
  • Allergy to local anesthetics
  • Patients with a contraindication to regional anesthesia (coagulopathy, local infection, etc.)

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Erasme Hospital

    Brussels, 1070

Other trials in Belgium

About this study

Pacemakers are currently placed at the Erasmus Hospital under local anesthesia performed by the surgeon, and the amount of local anesthetic agents sometimes reach the maximum permitted doses, with a risk of systemic toxicity. Moreover, these patients often present an associated conduction block. This represents a contraindication/constraint in the use of lidocaine 2% (local anesthesia frequently used by the surgeon to infiltrate). This study hypothesized that using a block of the supraclavicular nerve associated with a Pecs Block I. guided by ultrasound should require a smaller quantity of local anesthetic.

Read the detailed description

PECS 1 Block and Supraclavicular Nerve Block, were performed by an anesthesiologist under ultrasound control using a linear 8Mzt transducer, a Phillips HD 11 machine and a 50 mm needle Stimuplex 360 Braun. The ALR procedure was performed 30 minutes before the surgical incision. A volume of 15 ml of ropivacaine 3.75 mg/ml is used and distributed as follows: 12 ml for the Pecs 1 Block and 3 ml for the Supraclavicular nerve block: The patient was placed in supine position with the arm abducted at about 90 °, the puncture site being sterilized with betadine. The transducer was first placed in a subclavicular position in order to identify the major and minor pectoralis muscles, as well as the thoracoacromial artery, particularly the pectoral branch, additional color Doppler, was used for the identification of those vessels. The needle was directed in plane to the intermuscular space lying between the large and small pectoral, a careful avoidance of the thoracoacromial artery or its pectoral branch was ensured. The LA injection, under visual control of the spread between the two muscles, was initiated at the level of the 2nd and 3rd ribs after a classical aspiration test; 12 ml of the ropivacaine 0.375% were used. A spread of the LA appearing as an intermuscular hypoechoic "lens" was always searched.

Second, a supraclavicular nerve block was performed. We initially identified the C5 root and scanned cranially to visualize the superficial cervical plexus. then, moving caudally, the supraclavicular nerve was isolated appearing as a hypoechogenic structure between scalenus medius and posterior border of the sternocleidomastoid muscle. A total of 3 ml of ropivacaine 0,375% was deposited nearby this nerve.

In the ALC group (Anesthesia Local Surgeon's Anesthesia: Local Infiltration of N = 15 tissues) 15 ml Ropivacaine 3.75 mg/ml were injected in the subclavicular area, as usual, starting from the skin to the depth of the muscles.

In case of patient discomfort or failure of the techniques used, a further local infiltration consisting of a maximum of 10 ml lidocaine 2% performed as required by the surgeon was allowed as rescue. If this failed, the depth of sedation would gradually increase and ventilation would be controlled either by face or laryngeal mask Propofol 1-3 mg / Kg / IV + sufentanyl 2.5 μg / IV).

Conditions
Pain, Pacemaker Ddd
Being tested
Local anesthesia made by surgeon, Regional anesthesia group
Keywords
regional anesthesia
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local anesthesia made by surgeonProcedure or surgery

    infiltration with local anesthetics

  • Regional anesthesia groupProcedure or surgery

    Pecs block I and Supraclavicular nerf block

Study groups in NCT04067024
Study groupRoleWhat they receive
Local anesthesia by the surgeon (LAS)Active comparatorLocal infiltration (ropivacaine 3,75 mg/ml) by surgeon
Receives: Procedure: Local anesthesia made by surgeon
Regional anesthesia group (LRA):ExperimentalBy ultrasound, a pecs block I associated with a supraclavicular nerf block is performed. (Ropivacaine 3,75 mg/ml)
Receives: Procedure: Regional anesthesia group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volume of local anesthetics used

    ml

    Measured: 24 hour

Secondary outcomes (2)
  1. Pain scoring

    Visual analog scale

    Measured: 24 hours

  2. Post-operative Paracetamol dose

    paracetamol mg

    Measured: 24h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2019
  2. Study start18 Jan 2017
  3. Primary completion7 Jul 2017
  4. Study completion7 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067024
Sponsor's protocol ID
P2016/447
Status last verified
Mar 2018
First submitted
12 Mar 2018
Last updated
26 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Local anesthesia made by surgeon and Regional anesthesia group in people with Pain and Pacemaker Ddd, run by Erasme University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume of local anesthetics used (time frame: 24 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.

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