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Completed

NCT Number: NCT04067024

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, 1070, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.)

Treatment and study plan

Local anesthesia made by surgeon

Procedure

infiltration with local anesthetics

Regional anesthesia group

Procedure

Pecs block I and Supraclavicular nerf block

Primary outcomes

  1. Volume of local anesthetics used

    Time frame: 24 hour

    ml

Secondary outcomes

  1. Pain scoring

    Time frame: 24 hours

    Visual analog scale

  2. Post-operative Paracetamol dose

    Time frame: 24h

    paracetamol mg

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 26, 2019
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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