Clinical trial NCT04184349
Conditions: Analgesia After Pacemaker AICDS Implantation Pediatrics
Keywords: pacemaker AICDS regional anesthesia
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2020-10-01; Completion date: 2022-06-09
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LA group intervention 2: B Group
Intervention descriptions: intervention 1: In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site. intervention 2: In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Protocol documents:
Prot_SAP_000.pdf: 
IRB NUMBER: HSC-MS-19-0760 
IRB APPROVAL DATE: 12/19/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Truncal ultrasound guided regional anesthesia for implantation and revision of 
AICDs and pacemakers in pediatric patients 
 
NCT04184349 
 
Version Date: 12/19/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


IRB NUMBER: HSC-MS-19-0760 
IRB APPROVAL DATE: 12/19/2019 
 
Title: Truncal ultrasound guided regional anesthesia for implantation and revision of AICDs 
and pacemakers in pediatric patients. 
 
PI: Olga Pawelek (Anesthesiologist) 
Co PIs: Mohammed Numan (Electrophysiologist), Chandra Srinivasan (Electrophysiologist), 
Richard Hubbard (Anesthesiologist), Evelyn Griffin (Anesthesiologist), Anil DeSilva 
(Anesthesiologist), Nischal Gautam (Anesthesiologist) 
 
Population: Children undergoing pacemaker and/or Automatic Implantable Cardioverter 
Defibrillator implantation at Children’s Memorial Hermann Hospital 
 
Study Duration: Data will be collected from procedure for 48 hours 
 
Purpose 
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker 
and Automatic Implantable Cardioverter Defibrillator implantation in children 
 
Hypothesis Truncal block is effective, safe and feasible for implantation of AICDs and 
pacemakers in children. 
 
Research Design and Procedures to be Used 
Written consent for the study will be obtained from a parent. We will also obtain consent from the 
patient if they are older than 10 years together with their parents. 
The patients will be simply randomized by a pre-determined computer generated random numbers 
and allocated to one of two groups. The group allocation (LA group or B group) will be concealed 
in sealed opaque envelopes that will be opened after enrollment of the patients. In one group (the 
LA group), only the local anesthetic infiltration will be performed. In the block group (the B 
group), PECS and TTP blocks will be performed. The ultrasound-guided nerve blocks will be 
performed by the anesthesiologist after induction of anesthesia and endotracheal intubation. The 
left upper extremity angiogram will be performed prior to block to ensure the correct side for the 
implant. The local anesthetic group will have wound infiltration as routine care by the 
electrophysiologist at the time of wound closure. Both of these blocks have been used successfully 
in our institution and the purpose of the study is to prospectively evaluate whether there is a 
decrease in amount of narcotic medications need and track complications. There is no deviation 
from the standard of care as currently practiced. 
 
At our institution, the incision is typically made below the clavicle on the left anterior chest wall 
and a subcutaneous (pre-pectoralis major) pocket or sub-muscular pocket is created between 
pectoralis major and minor muscles with sharp and blunt dissection and electrocautery by the 
electrophysiologist. Based on the literature this area is best covered by a PECS block combined 
with the transversus thoracic muscle plane block to help cover medial anterior nerve branches. (5) 
The adult literature describes mainly a combination of serratus plane block combined with 
transversus thoracic plane block as the generator is placed in the mid axillary line. (4). The dose 
of 0.2% ropivacaine is 1ml/kg and so for the block group the dose is divided into halves for the 
PECS block and TTP block (2 injections). For ultrasound-guided peripheral nerve block, we will 


IRB NUMBER: HSC-MS-19-0760 
IRB APPROVAL DATE: 12/19/2019 
 
use a 22-gauge 4 cm Pajunk needle and a linear probe of the SonoSite. The skin will be cleaned 
with chlorhexidine prep solution and aseptic technique followed. 
 
Pecs Block 
The goal of the Pecs block is to infiltrate the fascial compartment with local anesthetic 
ropivacaine between the pectoral nerves (the pectoral fascia and clavipectoral fascia). The local 
anesthetic should cover the pectoral compartment with the pectoral nerves. The block is performed 
with the patient supine, either with the arm abducted 90 degrees or by his or her side. The 
transducer is then moved laterally until the pectoralis minor and serratus anterior are identified. 
With further lateral transducer movement, the third and fourth rib can then be identified. The 
injection of 0.5 mL/kg of 0.2% ropivacaine is made between the pectoralis major and minor 
muscles.(Figure 2). 
 
TTP block 
A transversus thoracic plane block is added to provide sufficient analgesia to the area around 
the sternum. The ultrasound is placed on the left parasternal border at T3-4 level and moved 
medially until the plane between the internal intercostal and transversus thoracis muscles is 
identified immediately medial to the sternal border. Using an in-plane technique, 0.5mL/kg of 
0.2% ropivacaine is injected between the internal intercostal and transversus thoracis muscle plane. 
(Figure 3). 
 
The adjunctive medication protocol will include scheduled alternating ibuprofen and tylenol 
unless contraindicated by renal impairment. Both groups of patients will also have oral oxycodone 
available as needed for moderate breakthrough pain and IV morphine for severe pain. 
The total dose of local anesthetic for group B will be same as that of group LA. 
 
Primary outcome: We will compare the two groups on their total narcotic dose in milligram 
morphine equivalents (MME) needed for 48 hours after procedure. This is calculated as 
intravenous 
fentanyl 
(mcg) 
x0.03+intravenous 
hydromorphone 
(mg)x20+intravenous 
morphine(mg)x3+[number of oral oxycodone 5 mg/acetaminophen 325 mg tabs equivalents ]. The 
48 hour mark is picked since the local anesthetic duration for either local infiltration or block is 6- 
12 hours and most patients would be discharged prior to the 48 hour mark. This also allows for 
sufficient time for complications to develop and tracked as secondary outcomes. 
 
Secondary outcome: VAS pain score in PACU, incidence of pruritus, nausea/vomiting, 
respiratory depression, local anesthetic toxicity and pneumothorax, these complications would 
arise early in the post procedure period but would be tracked for 48 hours. 
 
Statistical Analysis 
Data will be analyzed within one month after completion of data collection for all enrolled patients. 
The de-identified data will be uploaded to PI’s UTH-Share account and shared with the statistician. 
We will report the summary statistics of demographics and disease-related characteristics for two 
groups. The primary endpoint, amount of morphine equivalent administered intra-operative and 
during the first 24 hours after procedure, will be summarized as median and inter-quartile, and 
depicted as side-by-side boxplot. Comparison between two groups will be evaluated by Wilcoxon 
rank sum test. We will report the incidence rates of side effects including pruritis and nausea, as 


IRB NUMBER: HSC-MS-19-0760 
IRB APPROVAL DATE: 12/19/2019 
 
well as complications including local anesthetic toxicity and pneumothorax. The Wald test will be 
used for comparing incidence rates between two groups. 
At our institution we performed 24 implants in the last 2 years (aicd/ppm,external, 4 were lead 
revisions, generator changes or pocket revisions. The most common approach used is the left intra- 
clavicular subcutaneous (pre-pectoral). We anticipate at least 12 patients per year going forward. 
Based on a 5% two-sided two-sample t test, the size of 12 patients per group provides the power 
of 94% for detecting difference for effect size 1.5 assuming that the primary endpoint follows a 
normal distribution 
 
Data and Safety Monitoring: 
 
Both groups will be followed for signs of local anesthetic toxicity, pneumothorax or infection, 
these will be reviewed at quarterly intervals with the cardiologist/anesthesiologist PIs. 
 
Risks and Potential Benefits 
The risks of wound infiltration (LA group) is the potential use of higher doses of narcotic which 
is associated with more nausea, pruritis and potential for respiratory depression. The block groups 
use has the risks of insufficient analgesia with the need for rescue medications, the use of a longer 
block needle has the theoretical risk of injury to deeper structures such as the lung but the use of 
ultrasound and experience with ultrasound of the anesthesiologist makes it a minimal risk. Risks 
with either technique are those associated with any injection: infection, bleeding and damage to 
surrounding structures. Both groups have the risk of local anesthetic toxicity. 
The benefit of the block group is the improved analgesia and decrease in the narcotic dose needed 
with a resulting decrease in narcotic associated side effects. 
The secondary outcomes will be incidence of pruritus, nausea/vomiting 
 
Importance of Knowledge That May Be Reasonably Expected To Result 
Truncal ultrasound guided blocks are gaining popularity due to their efficacy in the adult 
population for implantation of pacemakers and AICDs and so far there is a lack of reports of these 
being used in the pediatric population. Based on our experience with effectiveness of truncal 
blocks so far we anticipate encouraging other centers to integrate this modality and offer better 
pain control to their patients. 
 
Ethics 
The study has obtained departmental IRB approval and is seeking institutional IRB approval. 
Given very positive results from the adult population, we believe delaying this study will deprive 
large groups of children at other institutions from receiving a pain management technique that will 
improve their comfort and decrease the amount of narcotic needed. 
 
The consent and assent will be explained to family and patient and alternatives which include no 
randomization will be offered. 
 
A linking log will be used to deidentify data and a data sheet have been attached for review. The 
data sheets will be securely destroyed as soon as deidentified data is transferred to a electronic 
form on a secure server. The linking log will be stored in a locked cabinets within a locked office 
at the medical school. 


IRB NUMBER: HSC-MS-19-0760 
IRB APPROVAL DATE: 12/19/2019 
 
Any complications will be reviewed quarterly with the EP cardiology/anesthesiology group and 
will be referred for departmental quality review if there is an increase in the number of 
complications compared to current base line when both the pain management injections are 
currently performed as standard of care. 
 
References 
 
1.Miller, Marc ; Garg, Jalaj ; Salter, Benjamin ; Brouwer, Thomas ; Mittnacht, Alex ; 
Montgomery, Morgan ; Honikman, Rafael ; Arkonac, Derya ; Choudry, Subbarao ; 
Dukkipati, Srinivas ; Reddy, Vivek ; Weiner, Menachem. Feasibility of subcutaneous 
implantable cardioverter-defibrillator implantation with opioid sparing truncal plane 
blocks and deep sedation. Journal of Cardiovascular Electrophysiology, Jan 2019, 
Vol.30(1), p.141 
 
2.(Bashandy, GM and Abbas, DN. Pectoral nerves I and II blocks in multimodal analgesia for 
breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015; 40: 68–74; 
 
3. Wijayasinghe, N, Andersen, KG, and Kehlet, H. Analgesic and sensory effects of the pecs 
local anesthetic block in patients with persistent pain after breast cancer surgery: a pilot 
study. Pain Pract. 2016; 10.1111/papr.12423). 
 
4. Raza, Syed M. ; Vasireddy, Appa Rao ; Candido, Kenneth D. ; Winnie, Alon P. ; Masters, 
Robert W. A complete regional anesthesia technique for cardiac pacemaker insertion. 
Journal of Cardiothoracic and Vascular Anesthesia, 1991, Vol.5(1), pp.54-56 
 
5. Bhatt, Himani V. ; Hernandez, Nadia ; Shariat, Ali. Successful Use of Serratus and 
Transversus Thoracic Plane Blocks for Subcutaneous Implantable Cardioverter- 
Defibrillator Placement. Journal of Cardiothoracic and Vascular Anesthesia, February 
2018, Vol.32(1), pp.e22-e23 


IRB NUMBER: HSC-MS-19-0760 
IRB APPROVAL DATE: 12/19/2019