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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05283980




Registration number
NCT05283980
Ethics application status
Date submitted
8/03/2022
Date registered
17/03/2022
Date last updated
1/10/2024

Titles & IDs
Public title
Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement
Scientific title
Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement: A Pilot Study
Secondary ID [1] 0 0
2021P001063
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Postoperative 0 0
Pain, Acute 0 0
Pain, Chest 0 0
Pain 0 0
Satisfaction, Patient 0 0
Opioid Use, Unspecified 0 0
Opioids; Harmful Use 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 0.25% Bupivacaine

Experimental: Bupivacaine Group - Receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block

Placebo comparator: Control group - Receive up to 25 ml of normal 0.9% sodium chloride for the Pecs block


Treatment: Drugs: 0.25% Bupivacaine
The intervention group/ bupivacaine group will receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block in comparison to the control group that would receive 0.9% normal saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Opioid consumption
Timepoint [1] 0 0
24 hours peri-procedure
Secondary outcome [1] 0 0
Pain scores on a scale 1 - 10, 1 being the least pain and 10 being the worst pain
Timepoint [1] 0 0
at 1 hour, 12 hour and 24hours
Secondary outcome [2] 0 0
Patient satisfaction scores
Timepoint [2] 0 0
at 24 hours post-procedure

Eligibility
Key inclusion criteria
* Patients 18 years of age or older
* Undergoing CIED placement in electrophysiology lab
* Booked with anesthesia service for the procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Current participation in another interventional study
* Use of mechanical circulatory support device
* Emergent procedures
* Patients receiving other modalities of regional anesthesia like intrathecal morphine
* Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
* Current use of SSRI, TCA, anti-epileptics, gabapentin, or pregabalin as part of multimodal pain management
* Hypersensitivity to bupivacaine
* Hemodynamics related: Oxygenation outside of normal limits (defined as PaO2 < 60mmHg on an FiO2 of 1.0 or SpO2 < 85% within 30 minutes prior to drug administration), Received an infusion or bolus = 0.05 mcg/kg/min of epinephrine o Received an infusion or bolus = 0.50 mcg/kg/min of milrinone, Received an infusion or bolus = 0.20 mcg/kg/min of norepinephrine o Significant clinician or nursing concern, Hemodynamically unstable (defined as HR > 120, SBP < 80, MAP < 50 within 30 minutes prior to drug administration)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Beth Israel Deaconess Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sankalp Sehgal, MD
Address 0 0
Beth Israel Deaconess Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05283980