PainNCT04067024
Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker
A study testing Local anesthesia made by surgeon and Regional anesthesia group in people with Pain and Pacemaker Ddd, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Pacemakers are currently placed at the Erasmus Hospital under local anesthesia performed by the surgeon, and the amount of local anesthetic agents sometimes reach the maximum permitted doses, with a risk of systemic toxicity. Moreover, these patients often present an associated conduction block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pacemaker Ddd
- What is being tested?
- Local anesthesia made by surgeon and Regional anesthesia group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Jan 2017to 7 Jul 2017
- 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
- Women and men > 18 years of age
- Patients scheduled for the implantation of a pace-maker
Who cannot join
- Patients refusing to sign the consent
- Patients included in another protocol within 3 months
- Pregnant or breastfeeding patients
- Allergy to local anesthetics
- Patients with a contraindication to regional anesthesia (coagulopathy, local infection, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Pacemakers are currently placed at the Erasmus Hospital under local anesthesia performed by the surgeon, and the amount of local anesthetic agents sometimes reach the maximum permitted doses, with a risk of systemic toxicity. Moreover, these patients often present an associated conduction block. This represents a contraindication/constraint in the use of lidocaine 2% (local anesthesia frequently used by the surgeon to infiltrate). This study hypothesized that using a block of the supraclavicular nerve associated with a Pecs Block I. guided by ultrasound should require a smaller quantity of local anesthetic.
Read the detailed description
PECS 1 Block and Supraclavicular Nerve Block, were performed by an anesthesiologist under ultrasound control using a linear 8Mzt transducer, a Phillips HD 11 machine and a 50 mm needle Stimuplex 360 Braun. The ALR procedure was performed 30 minutes before the surgical incision. A volume of 15 ml of ropivacaine 3.75 mg/ml is used and distributed as follows: 12 ml for the Pecs 1 Block and 3 ml for the Supraclavicular nerve block: The patient was placed in supine position with the arm abducted at about 90 °, the puncture site being sterilized with betadine. The transducer was first placed in a subclavicular position in order to identify the major and minor pectoralis muscles, as well as the thoracoacromial artery, particularly the pectoral branch, additional color Doppler, was used for the identification of those vessels. The needle was directed in plane to the intermuscular space lying between the large and small pectoral, a careful avoidance of the thoracoacromial artery or its pectoral branch was ensured. The LA injection, under visual control of the spread between the two muscles, was initiated at the level of the 2nd and 3rd ribs after a classical aspiration test; 12 ml of the ropivacaine 0.375% were used. A spread of the LA appearing as an intermuscular hypoechoic "lens" was always searched.
Second, a supraclavicular nerve block was performed. We initially identified the C5 root and scanned cranially to visualize the superficial cervical plexus. then, moving caudally, the supraclavicular nerve was isolated appearing as a hypoechogenic structure between scalenus medius and posterior border of the sternocleidomastoid muscle. A total of 3 ml of ropivacaine 0,375% was deposited nearby this nerve.
In the ALC group (Anesthesia Local Surgeon's Anesthesia: Local Infiltration of N = 15 tissues) 15 ml Ropivacaine 3.75 mg/ml were injected in the subclavicular area, as usual, starting from the skin to the depth of the muscles.
In case of patient discomfort or failure of the techniques used, a further local infiltration consisting of a maximum of 10 ml lidocaine 2% performed as required by the surgeon was allowed as rescue. If this failed, the depth of sedation would gradually increase and ventilation would be controlled either by face or laryngeal mask Propofol 1-3 mg / Kg / IV + sufentanyl 2.5 μg / IV).
- Conditions
- Pain, Pacemaker Ddd
- Being tested
- Local anesthesia made by surgeon, Regional anesthesia group
- Keywords
- regional anesthesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia made by surgeonProcedure or surgery
infiltration with local anesthetics
Regional anesthesia groupProcedure or surgery
Pecs block I and Supraclavicular nerf block
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia by the surgeon (LAS) | Active comparator | Local infiltration (ropivacaine 3,75 mg/ml) by surgeon Receives: Procedure: Local anesthesia made by surgeon |
| Regional anesthesia group (LRA): | Experimental | By ultrasound, a pecs block I associated with a supraclavicular nerf block is performed. (Ropivacaine 3,75 mg/ml) Receives: Procedure: Regional anesthesia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of local anesthetics used
ml
Measured: 24 hour
Secondary outcomes (2)
Pain scoring
Visual analog scale
Measured: 24 hours
Post-operative Paracetamol dose
paracetamol mg
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start18 Jan 2017
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wendy Fernandez, Dr., Principal investigator, Erasme Hospital,Route de lenniek 808, 1070, Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067024
- Sponsor's protocol ID
- P2016/447
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Supraclavicular Block Associated With a Pecs Blocks I to Ensure Analgesia When Placing a Pacemaker
- ClinicalTrials.gov ID
- NCT04067024
- Acronym / sponsor ID
- P2016/447
- Conditions
- Pain, Pacemaker Ddd
- Keywords
- regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 26 Aug 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.
Pacemakers are currently placed at the Erasmus Hospital under local anesthesia performed by the surgeon, and the amount of local anesthetic agents sometimes reach the maximum permitted doses, with a risk of systemic toxicity. Moreover, these patients often present an associated conduction block. This represents a contraindication/constraint in the use of lidocaine 2% (local anesthesia frequently used by the surgeon to infiltrate). This study hypothesized that using a block of the supraclavicular nerve associated with a Pecs Block I. guided by ultrasound should require a smaller quantity of local anesthetic.
Detailed description
PECS 1 Block and Supraclavicular Nerve Block, were performed by an anesthesiologist under ultrasound control using a linear 8Mzt transducer, a Phillips HD 11 machine and a 50 mm needle Stimuplex 360 Braun. The ALR procedure was performed 30 minutes before the surgical incision. A volume of 15 ml of ropivacaine 3.75 mg/ml is used and distributed as follows: 12 ml for the Pecs 1 Block and 3 ml for the Supraclavicular nerve block: The patient was placed in supine position with the arm abducted at about 90 °, the puncture site being sterilized with betadine. The transducer was first placed in a subclavicular position in order to identify the major and minor pectoralis muscles, as well as the thoracoacromial artery, particularly the pectoral branch, additional color Doppler, was used for the identification of those vessels. The needle was directed in plane to the intermuscular space lying between the large and small pectoral, a careful avoidance of the thoracoacromial artery or its pectoral branch was ensured. The LA injection, under visual control of the spread between the two muscles, was initiated at the level of the 2nd and 3rd ribs after a classical aspiration test; 12 ml of the ropivacaine 0.375% were used. A spread of the LA appearing as an intermuscular hypoechoic "lens" was always searched.
Second, a supraclavicular nerve block was performed. We initially identified the C5 root and scanned cranially to visualize the superficial cervical plexus. then, moving caudally, the supraclavicular nerve was isolated appearing as a hypoechogenic structure between scalenus medius and posterior border of the sternocleidomastoid muscle. A total of 3 ml of ropivacaine 0,375% was deposited nearby this nerve.
In the ALC group (Anesthesia Local Surgeon's Anesthesia: Local Infiltration of N = 15 tissues) 15 ml Ropivacaine 3.75 mg/ml were injected in the subclavicular area, as usual, starting from the skin to the depth of the muscles.
In case of patient discomfort or failure of the techniques used, a further local infiltration consisting of a maximum of 10 ml lidocaine 2% performed as required by the surgeon was allowed as rescue. If this failed, the depth of sedation would gradually increase and ventilation would be controlled either by face or laryngeal mask Propofol 1-3 mg / Kg / IV + sufentanyl 2.5 μg / IV).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia by the surgeon (LAS) | Active comparator | Procedure: Local anesthesia made by surgeonLocal infiltration (ropivacaine 3,75 mg/ml) by surgeon |
| Regional anesthesia group (LRA): | Experimental | Procedure: Regional anesthesia groupBy ultrasound, a pecs block I associated with a supraclavicular nerf block is performed. (Ropivacaine 3,75 mg/ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women and men > 18 years of age
- Patients scheduled for the implantation of a pace-maker
Key exclusion criteria (5 listed)
- Patients refusing to sign the consent
- Patients included in another protocol within 3 months
- Pregnant or breastfeeding patients
- Allergy to local anesthetics
- Patients with a contraindication to regional anesthesia (coagulopathy, local infection, etc.)
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 |
|---|---|---|
| Local anesthesia made by surgeoninfiltration with local anesthetics | Procedure or surgery | Local anesthesia by the surgeon (LAS) |
| Regional anesthesia groupPecs block I and Supraclavicular nerf block | Procedure or surgery | Regional anesthesia group (LRA): |
Primary outcome
Volume of local anesthetics used
Time frame: 24 hour
ml
2 secondary outcomes
Pain scoring
Time frame: 24 hours
Post-operative Paracetamol dose
Time frame: 24h
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 26 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
wendy Fernandez, Dr. principal investigator
Erasme Hospital,Route de lenniek 808, 1070, Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthesia made by surgeon and Regional anesthesia group in people with Pain and Pacemaker Ddd, run by Erasme University Hospital at 1 site in Belgium.
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 5 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 26 Aug 2019. 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 Belgium. 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?
Volume of local anesthetics used (time frame: 24 hour). 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 26 Aug 2019.