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Effective Use of Pecs and Transversus Thoracics Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series

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ClinicalTrials.gov Identifier: NCT03899701
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Iyabo Muse, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date August 15, 2019
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
Addition of local anesthetic by Interventionalist [ Time Frame: within 4 hours ]
The primary objective is to evaluate the utilization of perioperative rescue medications, including the supplementation of local anesthesia by the Internationalist.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03899701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Presence of pain at the incision site at procedure start time [ Time Frame: 20 minutes after block ]
    Presence of pain at the incision site at procedure start time
  • VAS Scores at 30 minutes after procedure and at discharge time [ Time Frame: 30 minutes - 2 hours after procedure ]
    Comparison of VAS scores at 30 minutes after the procedure and at discharge time
  • Number of Patients with Prolong sensory deficit [ Time Frame: 7 days after procedure ]
    Long-term follow-up (7 days) of prolong sensory deficit to the chest area
  • Use of Supplemental Opioid greater than 100mcg of Fentanyl [ Time Frame: Within 4 hours ]
    The use of more than 100mcg of fentanyl by the anesthesiologists doing the case
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effective Use of Pecs and Transversus Thoracics Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series
Official Title  ICMJE Effective Use of PEC I, PEC II and Transversus Thoracics Muscle Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series
Brief Summary

Participants that undergo permanent cardiac pacemaker implantation can often present with challenging anesthetic management plans for the anesthesia provider. Typically, these procedures are performed in electrophysiology labs that are often in remote locations away from the main operating room suite. This presents the logistic challenges of not having standard anesthesia machines, equipment and medications readily available for these cases.Currently, the majority of these cases are done under local anesthesia with light to moderate sedation. However, when it comes to inserting more complex devices such as implantable cardiac defibrillators and cardiac resynchronization therapy devices, participants may not be able to tolerate these more invasive and painful procedures with only local anesthetic as the primary mode of analgesia.

Ultrasound-guided regional anesthetic techniques, in particular the pectoralis nerve blocks (PEC I and II) and the Transversus Thoracic Muscle plane block (TTP), offer an alternative mode of analgesia for these participants. PEC I blocks target the lateral and medial pectoral nerves by injecting local anesthetic in the fascial plane between the pectoralis major and minor muscles. PEC II blocks supplement the PEC I block by targeting the intercostal nerves with local anesthetic injected between the pectoralis minor and serratus anterior muscles. The transversus thoracic plane block targets the anterior cutaneous branches of the intercostal nerves. In combination, these four blocks would provide analgesia of the upper anterior chest wall.(3)These would provide effective analgesia of the upper anterior chest wall.(7).

However, there is a paucity of studies on the use of PEC blocks in cardiac pacemaker implantation procedures. There is a case report from 2014 on a 71 year-old male with an ejection fraction of 20% undergoing CRTD implantation, which showed that PECs block with moderate sedation using dexmedetomidine could be safely utilized to provide effective analgesia for the procedure.11 However, this was not a subcutaneous ICD that required tunneling of the coils. Thus there are no randomized controlled studies to investigate whether the use of peripheral nerve blocks as primary anesthetic choice could be a viable alternative for multiple participants undergoing subcutaneous ICD placement.

Detailed Description

This is a randomized controlled study evaluating the effectiveness of PEC I, PEC II, Transversus Thoracic plane blocks as the primary anesthetic in participants undergoing subcutaneous implantable defibrillator. There will be two groups; the nerve block group vs. general anesthesia group. The participants in the nerve block group will receive an ultrasound-guided nerve block in the electrophysiology suite prior to the start of the procedure. Participants will get a PEC I block with 10ml of 0.375% ropivacaine, PEC II block with 15ml of 0.375% ropivacaine, 15ml of 0.375% ropivacaine for TTP. PEC I block entails injecting local anesthesia between the pectoralis major and pectoralis minor muscles to anesthetize the medial and lateral pectoral nerves. PEC II block entails injecting local anesthetic between the pectoralis minor and serratus anterior muscles to block the upper intercostal nerves. For Tranversus Thoracic Plane block, local anesthetic will be injected between the internal intercostal muscle and the Transversus Thoracic muscle. The participants in the nerve block group will get mild sedation during the nerve blocks (midazolam 1-2mg IV and fentanyl 50-100mcg IV). After block placement, patient will be given a 0.3mcg/kg bolus of dexmedetomidine, then an infusion of dexmedetomidine 0.4mcg/kg/hr- 0.7mcg/kg/hr r +/- propofol 25mcg/kg/min-100mcg/kg/min for sedation. The general anesthesia group of participants will get the current standard of care with an endotracheal tube with a combination of IV induction medications and volatile anesthetic. Research assistant will hand an enclosed envelope to the anesthesiologists with the name of the group consented patient will be in.

Intraoperatively, the anesthesiologist will note if supplemental opioids and local anesthetic was required. Postoperatively, the PACU nurse will be asked to document pain scores according to the Visual Analog Scale (VAS) and total dose of opioids given. The distribution of the sensory block and motor weakness will be documented in the anesthesiologist's PACU discharge note. For postoperative data collection, opioid consumption totals and the pain scores at 30 minutes after arrival in PACU and at discharge.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia, Local
Intervention  ICMJE Procedure: PEC I and PEC II blocks
Participants will get a PEC I block with 10ml of 0.375% ropivacaine and a PEC II block with 20ml of 0.375% ropivacaine using ultrasound guidance.
Study Arms  ICMJE Experimental: PEC I and PEC II block
Ultrasound guided nerve block group.
Intervention: Procedure: PEC I and PEC II blocks
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient undergoing cardiac pacemaker placement Age 18 and above ASA II-IV

Exclusion Criteria:

  • Patient refusal
  • Inability to understand and sign consent
  • Infection at the injection site
  • Known allergy or hypersensitivity to ropivacaine or other amide local anesthetics
  • Coagulopathy (INR > 1.5)
  • Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time before the surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Iyabo Muse 7189207178 imuse@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03899701
Other Study ID Numbers  ICMJE 2019-9952
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No identifiable patient's data will be shared.
Responsible Party Iyabo Muse, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Celina Joco Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP