Catheter ComplicationsNCT03693755
Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane
A study testing In-plane Group and Out-of-plane Group in people with Catheter Complications, run by Jose Aguirre at 1 site in Switzerland.
Trial summary
Dislocation of the femoral nerve catheters, which are used as postoperative analgesic method after knie surgery, will be studied. Two Groups will be compared; in the first group the femoral nerve catheter will be placed sonographically with the in-plane technique, whereas in the other Group the femoral nerve catheter… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Complications
- What is being tested?
- In-plane Group and Out-of-plane Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Oct 2018to 28 May 2019
- 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
- American Society of Anesthesiologists class I-III patients, both sexes
- ≥ 18 years old
- Patients are undergoing major knie surgery at our University Hospital with standard use of regional anesthesia techniques to provide analgesia
Who cannot join
- Contraindications or allergy to the use of local anesthetics or other drugs used in the study.
- Women who are pregnant or breast feeding
- Women who have the intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator(s) in individual cases
- Patients with acute porphyria
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Show all 12Show fewer
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Previous enrollment into the current study
- BMI > 40
- Local inflammation in the inguinal area
- Patient refusal for regional anesthesia or participation in the study
- Enrollment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane: A Prospective Randomized Study
Dislocation of the femoral nerve catheters, which are used as postoperative analgesic method after knie surgery, will be studied. Two Groups will be compared; in the first group the femoral nerve catheter will be placed sonographically with the in-plane technique, whereas in the other Group the femoral nerve catheter will be placed sonographically with the out-of-plane technique
Read the detailed description
Patients scheduled for elective major knee surgery will be assessed for eligibility and after written informed consent included in this clinical trial. Prior to surgery, the patient will receive a femoral catheter with either ultrasound placed in-plane (IP) or with ultrasound placed out-of-plane (OOP) as perioperative analgesic regimen using well-established and previously published techniques. The allocation to the different groups will be according to a computerized random-list established the day prior to surgery. In all cases, continuous regional anaesthesia regimen will be started after surgery. For surgery the patient can receive spinal anaesthesia, or a general anaesthesia. The use of a sciatic block will be applied according to the clinical standards of our department. Ropivacaine 0.3% (bag with 100 ml, Sintetica SA, Mendrisio Switzerland) 20 ml for the femoral catheter insertion. In both groups 10ml of ropivacaine 0.3% will be applied over the needle and 10ml over the catheter after its placement. In both groups the catheters will be connected to the electronic pump in the recovery room and run with ropivacaine 0.3% at 6 ml/h with boli of 4ml every 20min.
First rescue medication: ropivacaine 0.3% 20ml up to 3 x day. The catheters will stay in place for 48 hours and removed only if VAS< 40 with standard analgesia.
At 24 and 48 hours after placement of the femoral catheter, a bolus of NaCl 0.9% 10ml will be applied under ultrasound control in both groups and dislocation will be noted if the local anaesthetic does not reach the femoral nerve. In that case it will be noted where the local anaesthetic is localised. Block quality will be checked by applying cold on the front of the knee and measuring the sensation to cold in a scale from 0 to 2 (before NaCl 0.9% application). Pain will be assessed before the dislocation test only for in front and medial side of the knee in a regularly used NRS scale from 0 to 10. Complications and side effects of regional anesthesia in both groups will be documented (toxicity, blood in catheter, infection).
- Conditions
- Catheter Complications
- Being tested
- In-plane Group, Out-of-plane Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-plane GroupProcedure or surgery
Placement of femoral nerve catheter under ultrasound control
Out-of-plane GroupProcedure or surgery
Placement of femoral nerve catheter under ultrasound control
| Study group | Role | What they receive |
|---|---|---|
| In-plane Group | Active comparator | In this Group the femoral nerve catheter will be placed with the in-plane technique. Receives: Procedure: In-plane Group; Procedure: Out-of-plane Group |
| Out-of-plane Group | Active comparator | In this Group the femoral nerve catheter will be placed with the out-of-plane technique. Receives: Procedure: In-plane Group; Procedure: Out-of-plane Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dislocation of the femoral nerve catheter at 48 hours after its placement.
The catheter will be checked if in the right place using ultrasound location
Measured: 48 hours after the placement of the catheter
Secondary outcomes (7)
Time to place the catheter
Time to place the catheter measured in seconds
Measured: 30min (time needed to place and fix a femoral catheter)
satisfaction of the patient
satisfaction of the Patient during the block procedure in a scale of 0 to 10 (0 being not satisfied at all and 10 being totally satisfied)
Measured: 48 hours after the placement of the catheter
number of failed blocks
number of failed blocks needed to be repeated
Measured: 30min (time needed to place and fix a femoral catheter and regognize if it works)
difficulty placing the catheter
difficulty placing the catheter under ultrasound control
Measured: 30min (time needed to place and fix a femoral catheter and to decide if it was difficult)
Effect of the femoral catheter on the sensory sensation
cold (cold metal bar) and pinprick (atraumatic test, using a sharp tip): can the patient recognize cold and sharp during the femoral nerve block? Answers are yes or no.
Measured: at 24 hours and 48 hours after the femoral nerve catheter
rescue boli given over the catheter in the 48 hours after its placement
amount of local anaesthetic rescue boli given
Measured: At 48 hours after the placement of the catheter
Dislocation of the femoral nerve catheter at 24 hours after its placement.
amount of catheter dislocations
Measured: At 24 and at 48 hours after the placement of the catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start24 Oct 2018
- Primary completion20 Feb 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 Group will be compared to another
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Aguirre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Aguirre, Balgrist University Hospital
- Investigators
- Urs Eichenberger, Prof. Dr. med., Study chair, Department of Anaesthesia, Intensive Care and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693755
- Sponsor's protocol ID
- 2018-00940
- Other IDs
- 2018
- Status last verified
- Jun 2019
- First submitted
- 27 Jun 2018
- Last updated
- 21 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalimeris K, Rupnik B, Allenspach K, Fucentese SF, Gotschi T, Aguirre J, Eichenberger U. Dislocation rates of perineural catheters placed either perpendicular or parallel to the femoral nerve: A randomised controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):758-764. doi: 10.1097/EJA.0000000000001237.
PubMed 32453168
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03693755
- Acronym / sponsor ID
- 2018-00940
- Conditions
- Catheter Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jose AguirreUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 3 Oct 2018 (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.
Dislocation of the femoral nerve catheters, which are used as postoperative analgesic method after knie surgery, will be studied. Two Groups will be compared; in the first group the femoral nerve catheter will be placed sonographically with the in-plane technique, whereas in the other Group the femoral nerve catheter will be placed sonographically with the out-of-plane technique
Detailed description
Patients scheduled for elective major knee surgery will be assessed for eligibility and after written informed consent included in this clinical trial. Prior to surgery, the patient will receive a femoral catheter with either ultrasound placed in-plane (IP) or with ultrasound placed out-of-plane (OOP) as perioperative analgesic regimen using well-established and previously published techniques. The allocation to the different groups will be according to a computerized random-list established the day prior to surgery. In all cases, continuous regional anaesthesia regimen will be started after surgery. For surgery the patient can receive spinal anaesthesia, or a general anaesthesia. The use of a sciatic block will be applied according to the clinical standards of our department. Ropivacaine 0.3% (bag with 100 ml, Sintetica SA, Mendrisio Switzerland) 20 ml for the femoral catheter insertion. In both groups 10ml of ropivacaine 0.3% will be applied over the needle and 10ml over the catheter after its placement. In both groups the catheters will be connected to the electronic pump in the recovery room and run with ropivacaine 0.3% at 6 ml/h with boli of 4ml every 20min.
First rescue medication: ropivacaine 0.3% 20ml up to 3 x day. The catheters will stay in place for 48 hours and removed only if VAS< 40 with standard analgesia.
At 24 and 48 hours after placement of the femoral catheter, a bolus of NaCl 0.9% 10ml will be applied under ultrasound control in both groups and dislocation will be noted if the local anaesthetic does not reach the femoral nerve. In that case it will be noted where the local anaesthetic is localised. Block quality will be checked by applying cold on the front of the knee and measuring the sensation to cold in a scale from 0 to 2 (before NaCl 0.9% application). Pain will be assessed before the dislocation test only for in front and medial side of the knee in a regularly used NRS scale from 0 to 10. Complications and side effects of regional anesthesia in both groups will be documented (toxicity, blood in catheter, infection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1 Group will be compared to another
| Arm | Type | Receives |
|---|---|---|
| In-plane Group | Active comparator | Procedure: In-plane Group, Procedure: Out-of-plane GroupIn this Group the femoral nerve catheter will be placed with the in-plane technique. |
| Out-of-plane Group | Active comparator | Procedure: In-plane Group, Procedure: Out-of-plane GroupIn this Group the femoral nerve catheter will be placed with the out-of-plane technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists class I-III patients, both sexes
- ≥ 18 years old
- Patients are undergoing major knie surgery at our University Hospital with standard use of regional anesthesia techniques to provide analgesia
Key exclusion criteria (12 listed)
- Contraindications or allergy to the use of local anesthetics or other drugs used in the study.
- Women who are pregnant or breast feeding
- Women who have the intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator(s) in individual cases
- Patients with acute porphyria
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 |
|---|---|---|
| In-plane GroupPlacement of femoral nerve catheter under ultrasound control | Procedure or surgery | In-plane Group, Out-of-plane Group |
| Out-of-plane GroupPlacement of femoral nerve catheter under ultrasound control | Procedure or surgery | In-plane Group, Out-of-plane Group |
Primary outcome
Dislocation of the femoral nerve catheter at 48 hours after its placement.
Time frame: 48 hours after the placement of the catheter
The catheter will be checked if in the right place using ultrasound location
7 secondary outcomes
Time to place the catheter
Time frame: 30min (time needed to place and fix a femoral catheter)
satisfaction of the patient
Time frame: 48 hours after the placement of the catheter
number of failed blocks
Time frame: 30min (time needed to place and fix a femoral catheter and regognize if it works)
difficulty placing the catheter
Time frame: 30min (time needed to place and fix a femoral catheter and to decide if it was difficult)
Effect of the femoral catheter on the sensory sensation
Time frame: at 24 hours and 48 hours after the femoral nerve catheter
rescue boli given over the catheter in the 48 hours after its placement
Time frame: At 48 hours after the placement of the catheter
Dislocation of the femoral nerve catheter at 24 hours after its placement.
Time frame: At 24 and at 48 hours after the placement of the catheter
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 21 Jun 2019.
- Derived from this study: PubMed 32453168Kalimeris K, Rupnik B, Allenspach K, Fucentese SF, Gotschi T, Aguirre J, Eichenberger U. Dislocation rates of perineural catheters placed either perpendicular or parallel to the femoral nerve: A randomised controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):758-764. doi: 10.1097/EJA.0000000000001237.
- Individual participant dataSharing planned: No
Related trials for Catheter Complications
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer
Bladder Cancer
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
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.
Urs Eichenberger, Prof. Dr. med. study chair
Department of Anaesthesia, Intensive Care and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-plane Group and Out-of-plane Group in people with Catheter Complications, run by Jose Aguirre at 1 site in Switzerland.
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 3 inclusion and 12 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 21 Jun 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 Switzerland. 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?
Dislocation of the femoral nerve catheter at 48 hours after its placement. (time frame: 48 hours after the placement of the catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03693755, which also lists 1 linked publication.
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 21 Jun 2019.