Intraoperative PainNCT04974762
Truncal Blocks Versus Wound Infiltration for SICD
A study testing Wound infiltration and Truncal blocks in people with Intraoperative Pain and Postoperative Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Pain, Postoperative Pain
- What is being tested?
- Wound infiltration and Truncal blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2019to 18 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients undergoing S-ICD placement
Who cannot join
- Allergy to amide local anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Morningside Hospital Center
New York, New York, 10025
About this study
Official title: Comparing Truncal Blocks Versus Wound Infiltration for Subcutaneous Implantable Cardioverter Defibrillator Implantation
This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay.
Read the detailed description
This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay. The procedures involved for the study are the placement of the described truncal blocks or wound infiltration. Data to be collected are patient demographics, history of present illness, past medical history, and pain management techniques required (i.e non-narcotics and narcotics use). In addition, age, race, gender and BMI will also be collected. Intraoperative analgesia requirements, postoperative analgesia requirements, duration of procedure and length of stay will also be collected.
- Conditions
- Intraoperative Pain, Postoperative Pain
- Being tested
- Wound infiltration, Truncal blocks
- Keywords
- Subcutaneous implantable cardioverter-defibrillators (S-ICD), Truncal blocks
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound infiltrationProcedure or surgery
Surgical wound infiltration by proceduralist
Truncal blocksProcedure or surgery
Truncal blocks provided by anesthesiology team for device placement
| Study group | Role | What they receive |
|---|---|---|
| Wound infiltration | Active comparator | Standard intervention - surgical infiltration with local anesthetics Receives: Procedure: Wound infiltration |
| Truncal blocks | Experimental | Truncal block for anesthetics Receives: Procedure: Truncal blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and postoperative opioid consumption
Total intraoperative and postoperative opioid consumption of subjects
Measured: Up to Post-Op Day 10
Secondary outcomes (7)
Non-opioid analgesic consumption
Total intraoperative and postoperative non-opioid analgesic consumption of subjects
Measured: Up to Post-Op Day 10
Sedation (propofol) requirements intraoperatively
Total propofol required by subjects intraoperatively
Measured: Day 1, Day of Surgery
Number of participants with ICU stay
Need of intensive care unit (ICU) stay
Measured: Up to Post-Op Day 10
Duration of ICU stay
Duration of intensive care unit (ICU) stay
Measured: Up to Post-Op Day 10
Visual Analog Pain score
Visual Analog Pain Score (VAS) - total scale from 0-10, with higher score indicating more pain
Measured: Up to Post-Op Day 10
Total procedure time
Total duration of procedure time measured in minutes
Measured: Day 1 at Surgery
Length of stay
Length of time in the postanesthesia care unit measured in minutes
Measured: Day 1 at Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start23 Jan 2019
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Nima Shariat, Icahn School of Medicine at Mount Sinai
- Investigators
- Ali Shariat, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974762
- Sponsor's protocol ID
- IRB-18-00379
- Status last verified
- Aug 2022
- First submitted
- 8 Jul 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Truncal Blocks Versus Wound Infiltration for Subcutaneous Implantable Cardioverter Defibrillator Implantation
- ClinicalTrials.gov ID
- NCT04974762
- Acronym / sponsor ID
- IRB-18-00379
- Conditions
- Intraoperative Pain, Postoperative Pain
- Keywords
- Subcutaneous implantable cardioverter-defibrillators (S-ICD), Truncal blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 23 Jul 2021 (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.
This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay.
Detailed description
This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay. The procedures involved for the study are the placement of the described truncal blocks or wound infiltration. Data to be collected are patient demographics, history of present illness, past medical history, and pain management techniques required (i.e non-narcotics and narcotics use). In addition, age, race, gender and BMI will also be collected. Intraoperative analgesia requirements, postoperative analgesia requirements, duration of procedure and length of stay will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound infiltration | Active comparator | Procedure: Wound infiltrationStandard intervention - surgical infiltration with local anesthetics |
| Truncal blocks | Experimental | Procedure: Truncal blocksTruncal block for anesthetics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Patients undergoing S-ICD placement
Key exclusion criteria (1 listed)
- Allergy to amide local anesthetics
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 |
|---|---|---|
| Wound infiltrationSurgical wound infiltration by proceduralist | Procedure or surgery | Wound infiltration |
| Truncal blocksTruncal blocks provided by anesthesiology team for device placement | Procedure or surgery | Truncal blocks |
Primary outcome
Intraoperative and postoperative opioid consumption
Time frame: Up to Post-Op Day 10
Total intraoperative and postoperative opioid consumption of subjects
7 secondary outcomes
Non-opioid analgesic consumption
Time frame: Up to Post-Op Day 10
Sedation (propofol) requirements intraoperatively
Time frame: Day 1, Day of Surgery
Number of participants with ICU stay
Time frame: Up to Post-Op Day 10
Duration of ICU stay
Time frame: Up to Post-Op Day 10
Visual Analog Pain score
Time frame: Up to Post-Op Day 10
Total procedure time
Time frame: Day 1 at Surgery
Length of stay
Time frame: Day 1 at Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Ali Shariat, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound infiltration and Truncal blocks in people with Intraoperative Pain and Postoperative Pain, run by Icahn School of Medicine at Mount Sinai 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intraoperative and postoperative opioid consumption (time frame: Up to Post-Op Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2022.