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.

Study Overview

• Status: Completed
• Conditions: Pain; Pacemaker Ddd
• Intervention / Treatment: Procedure: Local anesthesia made by surgeon; Procedure: Regional anesthesia group

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).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of local anesthetics used	ml	24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scoring	Visual analog scale	24 hours
Post-operative Paracetamol dose	paracetamol mg	24h

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: wendy Fernandez, Dr., Erasme Hospital,Route de lenniek 808, 1070, Brussels

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: regional anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: P2016/447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No