Hip Replacement ArthroplastyPhase 4NCT02162121
Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?
A Phase 4 study testing Continuous lumbar plexus: stimulating catheter, Spinal Anesthesia and Local anesthetic infusion in people with Hip Replacement Arthroplasty, run by ASST Gaetano Pini-CTO at 1 site in Italy.
Trial summary
Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Replacement Arthroplasty
- What is being tested?
- Continuous lumbar plexus: stimulating catheter, Spinal Anesthesia and Local anesthetic infusion
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to Oct 2016
- Phase
- Phase 4
- 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 undergoing total hip arthroplasty
Who cannot join
- diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters improve postoperative compared with conventional non-stimulating catheters.
- Conditions
- Hip Replacement Arthroplasty
- Being tested
- Continuous lumbar plexus: stimulating catheter, Spinal Anesthesia, Local anesthetic infusion, Intravenous analgesia, Opioids rescue analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous lumbar plexus: stimulating catheterProcedure or surgery
Perinervous stimulating catheter ("Stimulong", "Pajunk", Germany) will be insert in lumbar plexus through tuohy needle (18G, 100mm length). 15ml mepivacaine 1% are injected before the complete resolution of the spinal anesthesia.
Spinal AnesthesiaProcedure or surgery
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
Local anesthetic infusionProcedure or surgery
Continuous infusion (Mini Rythmic Evolution, Micrel) of ropivacaine 0,2% at 3ml/h, bolus 3 ml, lockout time 15 min, 12 ml/h maximum dose through perinervous catheter until 3rd postoperative day
Intravenous analgesiaProcedure or surgery
Ketorolac 30mg 3 times a day
Opioids rescue analgesiaProcedure or surgery
Buprenorphine 0,2mg twice a day if VAS>4
Mepivacaine 1%Drug
Levobupivacaine 0,5%Drug
Ropivacaine 0,2%Drug
Ketorolac 30mgDrug
Buprenorphine 0,2mgDrug
Stimulong, Pajunk, Germany.Device
Continuous lumbar plexus: non-stimulating catheterProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Stimulating catheter | Experimental | After Spinal Anesthesia (Levobupivacaine 0,5% 15mg) all patients in the arm will receive continuous lumbar plexus block with stimulating catheter ("Stimolong", "Pajunk", Germany). Mepivacaine 1% 15 ml will be administrated. As post-operative analgesia Ropivacaine 0,2% will be continuous administrated. Receives: Procedure: Continuous lumbar plexus: stimulating catheter; Procedure: Spinal Anesthesia; Procedure: Local anesthetic infusion; Procedure: Intravenous analgesia; Procedure: Opioids rescue analgesia; Drug: Mepivacaine 1%; Drug: Levobupivacaine 0,5%; Drug: Ropivacaine 0,2%; Drug: Ketorolac 30mg; Drug: Buprenorphine 0,2mg; Device: Stimulong, Pajunk, Germany. |
| Non-stimulating catheter | Active comparator | After Spinal Anesthesia (levobupivacaine 0,5% 15mg) all patients in the arm will receive continuous lumbar plexus block with non-stimulating catheter ("Stimolong", "Pajunk", Germany). Mepivacaine 1% 15ml will be administrated. As post-operative analgesia Ropivacaine 0,2% will be continuous administrated. Receives: Procedure: Spinal Anesthesia; Procedure: Local anesthetic infusion; Procedure: Intravenous analgesia; Procedure: Opioids rescue analgesia; Drug: Mepivacaine 1%; Drug: Levobupivacaine 0,5%; Drug: Ropivacaine 0,2%; Drug: Ketorolac 30mg; Drug: Buprenorphine 0,2mg; Device: Stimulong, Pajunk, Germany.; Procedure: Continuous lumbar plexus: non-stimulating catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local anesthetic consumption
Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.
Measured: 72h
Secondary outcomes (7)
Visual Analog scale (VAS) score
Evaluation of VAS static and VAS dynamic during first 72 postoperative hours
Measured: 72h postoperatively
Up and Go test
"up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair
Measured: 4th postoperative day
Opioids request
Opioids consumption will be recorded throughout 72 postoperative hours
Measured: 72h postoperatively
Quadriceps strength
evaluate bilateral muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°.
Measured: preoperative and 24h, 48h, 72h postoperatively
postoperative nausea and vomiting (PONV)
Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4
Measured: 72h postoperatively
Needle redirections
During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder.
Measured: During catheter position
Catheter insertion time
Time (minutes) needed for catheter placement
Measured: During catheter positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Replacement ArthroplastyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Cappelleri, ASST Gaetano Pini-CTO
- Investigators
- Gianluca Cappelleri, M.D., Principal investigator, ASST Gaetano Pini-CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162121
- Sponsor's protocol ID
- IOGPGC06-14
- Status last verified
- Aug 2017
- First submitted
- 9 Jun 2014
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?
- ClinicalTrials.gov ID
- NCT02162121
- Acronym / sponsor ID
- IOGPGC06-14
- Conditions
- Hip Replacement Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Jun 2014 (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.
Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters improve postoperative compared with conventional non-stimulating catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulating catheter | Experimental | Procedure: Continuous lumbar plexus: stimulating catheter, Procedure: Spinal Anesthesia, Procedure: Local anesthetic infusion, Procedure: Intravenous analgesia, Procedure: Opioids rescue analgesia, Drug: Mepivacaine 1%, Drug: Levobupivacaine 0,5%, Drug: Ropivacaine 0,2%, Drug: Ketorolac 30mg, Drug: Buprenorphine 0,2mg, Device: Stimulong, Pajunk, Germany.After Spinal Anesthesia (Levobupivacaine 0,5% 15mg) all patients in the arm will receive continuous lumbar plexus block with stimulating catheter ("Stimolong", "Pajunk", Germany). Mepivacaine 1% 15 ml will be administrated. As post-operative analgesia Ropivacaine 0,2% will be continuous administrated. |
| Non-stimulating catheter | Active comparator | Procedure: Spinal Anesthesia, Procedure: Local anesthetic infusion, Procedure: Intravenous analgesia, Procedure: Opioids rescue analgesia, Drug: Mepivacaine 1%, Drug: Levobupivacaine 0,5%, Drug: Ropivacaine 0,2%, Drug: Ketorolac 30mg, Drug: Buprenorphine 0,2mg, Device: Stimulong, Pajunk, Germany., Procedure: Continuous lumbar plexus: non-stimulating catheterAfter Spinal Anesthesia (levobupivacaine 0,5% 15mg) all patients in the arm will receive continuous lumbar plexus block with non-stimulating catheter ("Stimolong", "Pajunk", Germany). Mepivacaine 1% 15ml will be administrated. As post-operative analgesia Ropivacaine 0,2% will be continuous administrated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing total hip arthroplasty
Key exclusion criteria (1 listed)
- diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic
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 |
|---|---|---|
| Continuous lumbar plexus: stimulating catheterPerinervous stimulating catheter ("Stimulong", "Pajunk", Germany) will be insert in lumbar plexus through tuohy needle (18G, 100mm length). 15ml mepivacaine 1% are injected before the complete resolution of the spinal anesthesia. | Procedure or surgery | Stimulating catheter |
| Spinal AnesthesiaSpinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected. | Procedure or surgery | Non-stimulating catheter, Stimulating catheter |
| Local anesthetic infusionContinuous infusion (Mini Rythmic Evolution, Micrel) of ropivacaine 0,2% at 3ml/h, bolus 3 ml, lockout time 15 min, 12 ml/h maximum dose through perinervous catheter until 3rd postoperative day | Procedure or surgery | Non-stimulating catheter, Stimulating catheter |
| Intravenous analgesiaKetorolac 30mg 3 times a day | Procedure or surgery | Non-stimulating catheter, Stimulating catheter |
| Opioids rescue analgesiaBuprenorphine 0,2mg twice a day if VAS>4 | Procedure or surgery | Non-stimulating catheter, Stimulating catheter |
| Mepivacaine 1% | Drug | Non-stimulating catheter, Stimulating catheter |
| Levobupivacaine 0,5% | Drug | Non-stimulating catheter, Stimulating catheter |
| Ropivacaine 0,2% | Drug | Non-stimulating catheter, Stimulating catheter |
| Ketorolac 30mg | Drug | Non-stimulating catheter, Stimulating catheter |
| Buprenorphine 0,2mg | Drug | Non-stimulating catheter, Stimulating catheter |
| Stimulong, Pajunk, Germany. | Device | Non-stimulating catheter, Stimulating catheter |
| Continuous lumbar plexus: non-stimulating catheter | Procedure or surgery | Non-stimulating catheter |
Primary outcome
Local anesthetic consumption
Time frame: 72h
Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.
7 secondary outcomes
Visual Analog scale (VAS) score
Time frame: 72h postoperatively
Up and Go test
Time frame: 4th postoperative day
Opioids request
Time frame: 72h postoperatively
Quadriceps strength
Time frame: preoperative and 24h, 48h, 72h postoperatively
postoperative nausea and vomiting (PONV)
Time frame: 72h postoperatively
Needle redirections
Time frame: During catheter position
Catheter insertion time
Time frame: During catheter positioning
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 14 Aug 2017.
Related trials for Hip Replacement Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
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.
Gianluca Cappelleri, M.D. principal investigator
ASST Gaetano Pini-CTO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous lumbar plexus: stimulating catheter, Spinal Anesthesia and Local anesthetic infusion in people with Hip Replacement Arthroplasty, run by ASST Gaetano Pini-CTO at 1 site in Italy.
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 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 14 Aug 2017. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Local anesthetic consumption (time frame: 72h). 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 14 Aug 2017.