Cardiac IED ImplantationNCT03061292
Cardiac Implantable Electronic Device Implantation With and Without Pectoral Nerve Block
A study testing Pectoral Nerve Block and Without Pectoral Nerve Block in people with Cardiac IED Implantation, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Implantation of cardiac implantable electronic devices are generally carried out using intermittent intravenous conscious sedation combined with local anaesthesia. The main advantage of this technique is in avoiding the potential risks of general anaesthesia. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Cardiac IED Implantation
- What is being tested?
- Pectoral Nerve Block and Without Pectoral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Jul 2016to Nov 2020
- 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 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilled the indication for CIED implantation as defined in 2008 guidelines for device-based therapy of cardiac rhythm abnormalities
Who cannot join
- Pregnant
- Those who receives subcutaneous implantable cardioverter defibrillator
- Vulnerable subjects (children, prisoners, cognitive impaired persons)
- Known history of allergy to local anaesthetic medications
Trial locations and contacts
1 site in 1 country.
Vern Hsen Tan, MBBS contact
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
CTRU, 67888833
About this study
Official title: A Randomized, Controlled Trial on Patients Undergoing Cardiac Implantable Electronic Device Implantation With Local Anaesthesia and Sedation With and Without Pectoral Nerve Block
Implantation of cardiac implantable electronic devices are generally carried out using intermittent intravenous conscious sedation combined with local anaesthesia. The main advantage of this technique is in avoiding the potential risks of general anaesthesia. However, the use of this Sedation - Local Anaesthesia technique is not without complications. Peri -procedural hypoxaemia and hypotension are well recognised complications of this technique.
The pectoral nerves (Pecs) blocks are novel techniques to block the pectoral, intercostobrachial, third to sixth intercostals, and the long thoracic nerves. PECS block targets the lateral and median pectoral nerves at an interfascial plane between the pectoralis major and minor muscles.
Read more
A case report by Fujiwara et al has described the use of this technique to provide good analgesia during and after these implantation procedures surgery. Pectoral nerves block along with minimal sedation has been used as a safe technique in our local set up as well.
Hence, we propose a randomized, single center, controlled trial on patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with and without Pectoral Nerve Block.
Read the detailed description
Intervention group:
Pectoral nerve block will be performed by anaesthetist (not blinded) in cardiac catheterization laboratory using ultrasound guidance and strict aseptic technique.
Control group:
A sham "block" will be performed by anaesthetist in cardiac catheterization laboratory using strict aseptic technique.
Patients of both groups will be monitored by the Cardiologist ( performing the procedure) and the Nurse from the monitoring room.
A minimum period of 15 minutes will be allowed following the block, prior to device implantation procedure by cardiologist.
Numeric rating scale (NRS) will be used for assessment of pain. The assessment will be carried out at every 15 minutes from the start of the procedure till the end of the procedure (0, 15, 30, 45, 60 minutes etc) and also at specific time points. Numerical rating scale will also be assessed when the patient experiences pain at any point and in the recovery room (0, 15, 30 and if needed, 45, 60 minutes).
Further post-operative pain scores will be collected at 4 hours and 8 hours post-procedure.
- Conditions
- Cardiac IED Implantation
- Being tested
- Pectoral Nerve Block, Without Pectoral Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral Nerve BlockProcedure or surgery
Without Pectoral Nerve BlockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pectoral Nerve Block | Experimental | Patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with pectoral nerve block Receives: Procedure: Pectoral Nerve Block |
| Without Pectoral Nerve Block | Sham comparator | Patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation without pectoral nerve block Receives: Procedure: Without Pectoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of sedation used
Measured: 2 years
Incidence of hypoxia, hypotension and hypopnea in the perioperative period
Measured: 2 years
Perioperative sedation scores
Measured: 2 years
Perioperative pain scores
Measured: 2 years
Post-anaesthetic discharge score
Measured: 2 years
Secondary outcomes (2)
Procedurist satisfaction scores
Measured: 2 years
Patient satisfaction scores
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start25 Jul 2016
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac IED ImplantationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061292
- Sponsor's protocol ID
- PECS
- Status last verified
- Oct 2020
- First submitted
- 14 Feb 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial on Patients Undergoing Cardiac Implantable Electronic Device Implantation With Local Anaesthesia and Sedation With and Without Pectoral Nerve Block
- ClinicalTrials.gov ID
- NCT03061292
- Acronym / sponsor ID
- PECS
- Conditions
- Cardiac IED Implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 23 Feb 2017 (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.
Implantation of cardiac implantable electronic devices are generally carried out using intermittent intravenous conscious sedation combined with local anaesthesia. The main advantage of this technique is in avoiding the potential risks of general anaesthesia. However, the use of this Sedation - Local Anaesthesia technique is not without complications. Peri -procedural hypoxaemia and hypotension are well recognised complications of this technique.
The pectoral nerves (Pecs) blocks are novel techniques to block the pectoral, intercostobrachial, third to sixth intercostals, and the long thoracic nerves. PECS block targets the lateral and median pectoral nerves at an interfascial plane between the pectoralis major and minor muscles.
A case report by Fujiwara et al has described the use of this technique to provide good analgesia during and after these implantation procedures surgery. Pectoral nerves block along with minimal sedation has been used as a safe technique in our local set up as well.
Hence, we propose a randomized, single center, controlled trial on patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with and without Pectoral Nerve Block.
Detailed description
Intervention group:
Pectoral nerve block will be performed by anaesthetist (not blinded) in cardiac catheterization laboratory using ultrasound guidance and strict aseptic technique.
Control group:
A sham "block" will be performed by anaesthetist in cardiac catheterization laboratory using strict aseptic technique.
Patients of both groups will be monitored by the Cardiologist ( performing the procedure) and the Nurse from the monitoring room.
A minimum period of 15 minutes will be allowed following the block, prior to device implantation procedure by cardiologist.
Numeric rating scale (NRS) will be used for assessment of pain. The assessment will be carried out at every 15 minutes from the start of the procedure till the end of the procedure (0, 15, 30, 45, 60 minutes etc) and also at specific time points. Numerical rating scale will also be assessed when the patient experiences pain at any point and in the recovery room (0, 15, 30 and if needed, 45, 60 minutes).
Further post-operative pain scores will be collected at 4 hours and 8 hours post-procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectoral Nerve Block | Experimental | Procedure: Pectoral Nerve BlockPatients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with pectoral nerve block |
| Without Pectoral Nerve Block | Sham comparator | Procedure: Without Pectoral Nerve BlockPatients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation without pectoral nerve block |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fulfilled the indication for CIED implantation as defined in 2008 guidelines for device-based therapy of cardiac rhythm abnormalities
Key exclusion criteria (4 listed)
- Pregnant
- Those who receives subcutaneous implantable cardioverter defibrillator
- Vulnerable subjects (children, prisoners, cognitive impaired persons)
- Known history of allergy to local anaesthetic medications
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 |
|---|---|---|
| Pectoral Nerve Block | Procedure or surgery | Pectoral Nerve Block |
| Without Pectoral Nerve Block | Procedure or surgery | Without Pectoral Nerve Block |
Primary outcome
Total dose of sedation used
Time frame: 2 years
Incidence of hypoxia, hypotension and hypopnea in the perioperative period
Time frame: 2 years
Perioperative sedation scores
Time frame: 2 years
Perioperative pain scores
Time frame: 2 years
Post-anaesthetic discharge score
Time frame: 2 years
2 secondary outcomes
Procedurist satisfaction scores
Time frame: 2 years
Patient satisfaction scores
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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.
Vern Hsen Tan, MBBS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pectoral Nerve Block and Without Pectoral Nerve Block in people with Cardiac IED Implantation, run by Changi General Hospital at 1 site in Singapore.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vern Hsen Tan, MBBS (vern_hsen_tan@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dose of sedation used (time frame: 2 years). The study lists 5 primary outcomes in all. 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 8 Oct 2020.