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

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ClinicalTrials.gov Identifier: NCT04067024
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Pain Pacemaker Ddd Procedure: Local anesthesia made by surgeon Procedure: Regional anesthesia group Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker
Actual Study Start Date : January 18, 2017
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : July 7, 2017

Arm Intervention/treatment
Active Comparator: Local anesthesia by the surgeon (LAS)
Local infiltration (ropivacaine 3,75 mg/ml) by surgeon
Procedure: Local anesthesia made by surgeon
infiltration with local anesthetics

Experimental: Regional anesthesia group (LRA):
By ultrasound, a pecs block I associated with a supraclavicular nerf block is performed. (Ropivacaine 3,75 mg/ml)
Procedure: Regional anesthesia group
Pecs block I and Supraclavicular nerf block




Primary Outcome Measures :
  1. Volume of local anesthetics used [ Time Frame: 24 hour ]
    ml


Secondary Outcome Measures :
  1. Pain scoring [ Time Frame: 24 hours ]
    Visual analog scale

  2. Post-operative Paracetamol dose [ Time Frame: 24h ]
    paracetamol mg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067024


Locations
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Belgium
Erasme Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: wendy Fernandez, Dr. Erasme Hospital,Route de lenniek 808, 1070, Brussels
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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT04067024    
Other Study ID Numbers: P2016/447
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erasme University Hospital:
regional anesthesia
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs