Orthopedic SurgeryNCT02737137
Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade
A study testing Manual measurement and Measurement with a gauge in people with Orthopedic Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- Manual measurement and Measurement with a gauge
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jan 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Orthopedic surgery
Who cannot join
- Allergy to local anesthetics
- ASA score >III
- Severe neuropathy
- puncture site disease
- parturient or breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHOQUET
France, Montpellier, 34295
Olivier CHOQUET
About this study
Official title: Monitoring Combining Neurostimulation and Ultrasound Guidance During the Realization of a Peripheral Nerve Block: Value of Objective Measurement of the Pressure of Injection of the Local Anesthetic
In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.
The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection during peripheral nerve blocks
Read the detailed description
Current recommendations for peripheral nerve block (PNB) procedure advocate combining ultrasound guidance and nerve stimulation.
Despite these different means of identification, nerves contacts and intraneural injection are frequent. Even rare, nerve damage may occur.
The nerve damage may be related to direct trauma with the needle or inadvertent intra-neural injection. High injection pressure of local anesthetic (AL) is an indicator that further characterize the location of the needle in terms of tissue density. In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.
The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection.
Group 1: ultrasound-guided technique PNB "in plane" needle approach, nerve stimulator set to sentinel mode. Manual injection pressure control Group 2: ultrasound-guided PNB, "in plane" approach, Nerve stimulator set to detection mode. Electronic Injection Pressure controlled with low flow local anesthetic during procedure
- Conditions
- Orthopedic Surgery
- Being tested
- Manual measurement, Measurement with a gauge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual measurementProcedure or surgery
Also called Manual measurement by the anesthetist
Monitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic
Measurement with a gaugeProcedure or surgery
Also called Measured by a pressure gauge
Monitoring by ultrasound, Neurostimulation and measurement with a gauge of the pressure of injection of the local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Manual measurement by the anesthetist | Other | Monitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic : Group 1 Receives: Procedure: Manual measurement |
| Measurement by a pressure gauge | Experimental | Monitoring by ultrasound, Neurostimulation and measurement with a gauge of the injection pressure of the local anesthetic : Group 2 Receives: Procedure: Measurement with a gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual measurement
Manual measurement of the pressure of injection of the local anesthetic during surgery for patients in Group 1
Measured: Intraoperative
Secondary outcomes (1)
Measured by a pressure gauge
Measured by a pressure gauge of the pressure of injection of the local anesthetic during surgery for patients in Group 2
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier CHOQUET, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737137
- Sponsor's protocol ID
- 9654
- Other IDs
- 2015-A01850-49
- Status last verified
- Jan 2016
- First submitted
- 1 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Combining Neurostimulation and Ultrasound Guidance During the Realization of a Peripheral Nerve Block: Value of Objective Measurement of the Pressure of Injection of the Local Anesthetic
- ClinicalTrials.gov ID
- NCT02737137
- Acronym / sponsor ID
- 9654
- Conditions
- Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 13 Apr 2016 (estimated)
- 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.
In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.
The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection during peripheral nerve blocks
Detailed description
Current recommendations for peripheral nerve block (PNB) procedure advocate combining ultrasound guidance and nerve stimulation.
Despite these different means of identification, nerves contacts and intraneural injection are frequent. Even rare, nerve damage may occur.
The nerve damage may be related to direct trauma with the needle or inadvertent intra-neural injection. High injection pressure of local anesthetic (AL) is an indicator that further characterize the location of the needle in terms of tissue density. In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.
The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection.
Group 1: ultrasound-guided technique PNB "in plane" needle approach, nerve stimulator set to sentinel mode. Manual injection pressure control Group 2: ultrasound-guided PNB, "in plane" approach, Nerve stimulator set to detection mode. Electronic Injection Pressure controlled with low flow local anesthetic during procedure
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual measurement by the anesthetist | Other | Procedure: Manual measurementMonitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic : Group 1 |
| Measurement by a pressure gauge | Experimental | Procedure: Measurement with a gaugeMonitoring by ultrasound, Neurostimulation and measurement with a gauge of the injection pressure of the local anesthetic : Group 2 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient
- Orthopedic surgery
Key exclusion criteria (5 listed)
- Allergy to local anesthetics
- ASA score >III
- Severe neuropathy
- puncture site disease
- parturient or breastfeeding
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 |
|---|---|---|
| Manual measurementAlso: Manual measurement by the anesthetistMonitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic | Procedure or surgery | Manual measurement by the anesthetist |
| Measurement with a gaugeAlso: Measured by a pressure gaugeMonitoring by ultrasound, Neurostimulation and measurement with a gauge of the pressure of injection of the local anesthetic | Procedure or surgery | Measurement by a pressure gauge |
Primary outcome
Manual measurement
Time frame: Intraoperative
Manual measurement of the pressure of injection of the local anesthetic during surgery for patients in Group 1
1 secondary outcome
Measured by a pressure gauge
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Orthopedic Surgery
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Enrolling by invitationPhase 4
PPP Versus Corticosteroid for Thigh Muscle Injuries
Thigh Muscle Injury, Thigh Injury
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.
Olivier CHOQUET principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual measurement and Measurement with a gauge in people with Orthopedic Surgery, run by University Hospital, Montpellier at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 13 Apr 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier CHOQUET, MD (4 67 33 82 56 ext. +33, o-choquet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual measurement (time frame: Intraoperative). 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 13 Apr 2016.