Pain Clinical Trial
Official title:
Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker
NCT number | NCT04067024 |
Other study ID # | P2016/447 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 18, 2017 |
Est. completion date | July 7, 2017 |
Verified date | March 2018 |
Source | Erasme University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | July 7, 2017 |
Est. primary completion date | July 7, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
Belgium | Erasme Hospital | Brussels |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volume of local anesthetics used | ml | 24 hour | |
Secondary | Pain scoring | Visual analog scale | 24 hours | |
Secondary | Post-operative Paracetamol dose | paracetamol mg | 24h |
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