Anesthesia, LocalNCT03899701
Effective Use of Pecs and Transversus Thoracics Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series
A study testing PEC I and PEC II blocks in people with Anesthesia, Local, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- PEC I and PEC II blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing cardiac pacemaker placement Age 18 and above ASA II-IV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center- Wakefield Campus
The Bronx, New York, 10467
About this study
Official title: Effective Use of PEC I, PEC II and Transversus Thoracics Muscle Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series
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.
Read the 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.
- Conditions
- Anesthesia, Local
- Being tested
- PEC I and PEC II blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEC I and PEC II blocksProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| PEC I and PEC II block | Experimental | Ultrasound guided nerve block group. Receives: Procedure: PEC I and PEC II blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Addition of local anesthetic by Interventionalist
The primary objective is to evaluate the utilization of perioperative rescue medications, including the supplementation of local anesthesia by the Internationalist.
Measured: within 4 hours
Secondary outcomes (4)
Presence of pain at the incision site at procedure start time
Presence of pain at the incision site at procedure start time
Measured: 20 minutes after block
VAS Scores at 30 minutes after procedure and at discharge time
Comparison of VAS scores at 30 minutes after the procedure and at discharge time
Measured: 30 minutes - 2 hours after procedure
Number of Patients with Prolong sensory deficit
Long-term follow-up (7 days) of prolong sensory deficit to the chest area
Measured: 7 days after procedure
Use of Supplemental Opioid greater than 100mcg of Fentanyl
The use of more than 100mcg of fentanyl by the anesthesiologists doing the case
Measured: Within 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study startNov 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: The study was never initiated and the PI has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celina Joco, Study director, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899701
- Sponsor's protocol ID
- 2019-9952
- Status last verified
- Jan 2022
- First submitted
- 28 Mar 2019
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable patient's data will be shared.
Publications
Kaya E, Sudkamp H, Lortz J, Rassaf T, Janosi RA. Feasibility and safety of using local anaesthesia with conscious sedation during complex cardiac implantable electronic device procedures. Sci Rep. 2018 May 8;8(1):7103. doi: 10.1038/s41598-018-25457-x.
PubMed 29740019Kim DH, Kim S, Kim CS, Lee S, Lee IG, Kim HJ, Lee JH, Jeong SM, Choi KT. Efficacy of Pectoral Nerve Block Type II for Breast-Conserving Surgery and Sentinel Lymph Node Biopsy: A Prospective Randomized Controlled Study. Pain Res Manag. 2018 May 15;2018:4315931. doi: 10.1155/2018/4315931. eCollection 2018.
PubMed 29861803Fujiwara A, Komasawa N, Minami T. Pectoral nerves (PECS) and intercostal nerve block for cardiac resynchronization therapy device implantation. Springerplus. 2014 Aug 5;3:409. doi: 10.1186/2193-1801-3-409. eCollection 2014.
PubMed 25120950
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Use of PEC I, PEC II and Transversus Thoracics Muscle Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series
- ClinicalTrials.gov ID
- NCT03899701
- Acronym / sponsor ID
- 2019-9952
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never initiated and the PI has left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEC I and PEC II block | Experimental | Procedure: PEC I and PEC II blocksUltrasound guided nerve block group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing cardiac pacemaker placement Age 18 and above ASA II-IV
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEC I and PEC II blocksParticipants 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. | Procedure or surgery | PEC I and PEC II block |
Primary outcome
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.
4 secondary outcomes
Presence of pain at the incision site at procedure start time
Time frame: 20 minutes after block
VAS Scores at 30 minutes after procedure and at discharge time
Time frame: 30 minutes - 2 hours after procedure
Number of Patients with Prolong sensory deficit
Time frame: 7 days after procedure
Use of Supplemental Opioid greater than 100mcg of Fentanyl
Time frame: Within 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Background: PubMed 29740019Kaya E, Sudkamp H, Lortz J, Rassaf T, Janosi RA. Feasibility and safety of using local anaesthesia with conscious sedation during complex cardiac implantable electronic device procedures. Sci Rep. 2018 May 8;8(1):7103. doi: 10.1038/s41598-018-25457-x.
- Background: PubMed 29861803Kim DH, Kim S, Kim CS, Lee S, Lee IG, Kim HJ, Lee JH, Jeong SM, Choi KT. Efficacy of Pectoral Nerve Block Type II for Breast-Conserving Surgery and Sentinel Lymph Node Biopsy: A Prospective Randomized Controlled Study. Pain Res Manag. 2018 May 15;2018:4315931. doi: 10.1155/2018/4315931. eCollection 2018.
- Background: PubMed 25120950Fujiwara A, Komasawa N, Minami T. Pectoral nerves (PECS) and intercostal nerve block for cardiac resynchronization therapy device implantation. Springerplus. 2014 Aug 5;3:409. doi: 10.1186/2193-1801-3-409. eCollection 2014.
- Individual participant dataSharing planned: No. No identifiable patient's data will be shared.
Related trials for Anesthesia, Local
Recruiting
Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children
Anesthesia, Local
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Not yet recruiting
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
Local Anesthesia in Dentistry
Active, not recruitingObservational study
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Ehlers-Danlos Syndrome, Anesthesia, Local
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celina Joco study director
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEC I and PEC II blocks in people with Anesthesia, Local, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Addition of local anesthetic by Interventionalist (time frame: within 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899701, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.