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

NCT04067024 | Completed DMC

• 1 other identifier: P2016/447
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Pacemaker Ddd

Keywords

regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Volume of local anesthetics used

  ml

  24 hour

Secondary Outcomes (2)

• Pain scoring

  24 hours

• Post-operative Paracetamol dose

  24h

Study Arms (2)

Local anesthesia by the surgeon (LAS)

ACTIVE COMPARATOR

Local infiltration (ropivacaine 3,75 mg/ml) by surgeon

Procedure: Local anesthesia made by surgeon

Regional anesthesia group (LRA):

EXPERIMENTAL

By ultrasound, a pecs block I associated with a supraclavicular nerf block is performed. (Ropivacaine 3,75 mg/ml)

Procedure: Regional anesthesia group

Interventions

Local anesthesia made by surgeon PROCEDURE

infiltration with local anesthetics

Local anesthesia by the surgeon (LAS)

Regional anesthesia group PROCEDURE

Pecs block I and Supraclavicular nerf block

Regional anesthesia group (LRA):

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• wendy Fernandez, Dr.

  Erasme Hospital,Route de lenniek 808, 1070, Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: August 26, 2019
• Study Start: January 18, 2017
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: August 26, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)