Orthopedic Surgical ProceduresPhase 4NCT01981291
Duration of Sciatic Nerve Block After Injection of Local Anesthetic In or Around the Nerve
A Phase 4 study testing Intraneural Injection for Subgluteal Sciatic Nerve Block, Perineural Injection for Subgluteal Sciatic Nerve Block and Femoral Nerve Block in people with Orthopedic Surgical Procedures and Postoperative Pain, run by University of Parma at 1 site in Italy.
Trial summary
This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), leads to longer anesthesia and analgesia of the leg. Some reports of accidental intraneural injection mention an extremely long duration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgical Procedures, Postoperative Pain
- What is being tested?
- Intraneural Injection for Subgluteal Sciatic Nerve Block, Perineural Injection for Subgluteal Sciatic Nerve Block and Femoral Nerve Block
- 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 siteItaly
- Study dates
- Oct 2012to Oct 2013
- 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
- Undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet
- ASA Physical Status Class I-III
- Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block)
Who cannot join
- Unable to understand or communicate for the purpose of the study
- Exhibiting signs of neuropathy in the ipsilateral extremity
- Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist
Trial locations and contacts
1 site in 1 country.
Italy1 site
Anesthesia, Critical Care and Pain Medicine - University of Parma
Parma, PR, 43126
About this study
Official title: Duration of Subgluteal Sciatic Nerve Block After Intra- or Perineural Injection of Mepivacaine: a Randomized, Controlled Trial
This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), leads to longer anesthesia and analgesia of the leg.
Some reports of accidental intraneural injection mention an extremely long duration. When different drugs and doses were evaluated in a clinical trial of intraneural injection, a longer-than-expected duration was reported.
The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference in duration.
Read the detailed description
This randomized, controlled trial will investigate prospectively for differences in sensory and motor block duration after intra- or perineural injection of 1.5% (wt/vol) mepivacaine, a short-acting local anesthetic.
- Conditions
- Orthopedic Surgical Procedures, Postoperative Pain
- Being tested
- Intraneural Injection for Subgluteal Sciatic Nerve Block, Perineural Injection for Subgluteal Sciatic Nerve Block, Femoral Nerve Block, Patient-controlled postoperative analgesia, Mepivacaine
- Keywords
- Lower Extremity, Sciatic Nerve, Anesthesia, Regional, Anesthetics, Local, Mepivacaine, Ultrasonography
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraneural Injection for Subgluteal Sciatic Nerve BlockProcedure or surgery
Also called Injection beneath the common investing external layer, Subepineural Injection, Gluteal sciatic nerve block, Subparaneural injection
The injection will start as the needle penetrates the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if nerve cross section expansion and a reduction in echogenicity are observed.
Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach.
Perineural Injection for Subgluteal Sciatic Nerve BlockProcedure or surgery
Also called Injection outside the common investing external layer, Epineural injection, Extraneural injection
The injection will start as the needle indents the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if the drug infiltrates the space between the epimysium of the surrounding muscles and the outer epineurium of the sciatic nerve.
Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach.
Femoral Nerve BlockProcedure or surgery
Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.
Patient-controlled postoperative analgesiaProcedure or surgery
Also called PCA, PCIVA, PCCPNB, Patient-controlled continuous peripheral nerve block
Patients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication.
MepivacaineDrug
Also called Local Anesthetic, Carbocaine
Thirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Perineural | Active comparator | Patients in this group will receive a perineural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Receives: Procedure: Perineural Injection for Subgluteal Sciatic Nerve Block; Procedure: Femoral Nerve Block; Procedure: Patient-controlled postoperative analgesia; Drug: Mepivacaine |
| Intraneural | Experimental | Patients in this group will receive an intraneural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia. Receives: Procedure: Intraneural Injection for Subgluteal Sciatic Nerve Block; Procedure: Femoral Nerve Block; Procedure: Patient-controlled postoperative analgesia; Drug: Mepivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Time to Resolution of Sciatic Nerve Block
The time at which sensory and motor function of the sciatic nerve have recovered at least to the following criteria:
- Sensory: patients feel discomfort when pricked with a thin needle (25G)
- Motor: patients may move both toes and ankle, albeit with reduced strength
This outcome measure will be examined by an investigator every 30-60 min and reported by patients as "time to return of sensation and movement". The investigator-reported value will be preferred if both are available.
Measured: <12 h
Secondary outcomes (3)
Block Onset Time
Time to onset of sciatic nerve anesthesia, defined as meeting at least the following criteria:
- Sensory: does not feel pain or discomfort when pricked with a 25G needle.
- Motor: able to slightly curl toes; unable to flex the ankle.
Measured: ≤30 min
Success Rate of Anesthetic Nerve Blocks
The percentage of patients who attain the criteria for block success within 30 minutes of the injeciton.
Investigators will also report the percentage of patients who successfully complete surgery without significant additional analgesia (see below); this will be defined as "clinical success rate."
Measured: ≤30 min
Incidence and Prevalence of Neurologic Disturbances
Patients will be interviewed at ~4 h (block resolution visit), 7 days and (if necessary) at 30 days to assess for residual neurologic disturbances in the sciatic nerve territory.
The incidence/prevalence of these phenomena will be noted.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthopedic Surgical ProceduresStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Baciarello, University of Parma
- Investigators
- Marco Baciarello, MD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981291
- Sponsor's protocol ID
- ANEST-ORT-03
- Status last verified
- Nov 2013
- First submitted
- 4 Nov 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Benhamou D, Blonski E, Levy P, Plessis E, Chalhoub V. Ultra-long duration of a peripheral nerve block: a possible consequence of intraneural (subepineural) local anaesthetic injection. Ann Fr Anesth Reanim. 2010 Jul-Aug;29(7-8):589-91. doi: 10.1016/j.annfar.2010.05.032. Epub 2010 Jul 13.
PubMed 20630694Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf.
PubMed 24108248
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Subgluteal Sciatic Nerve Block After Intra- or Perineural Injection of Mepivacaine: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01981291
- Acronym / sponsor ID
- ANEST-ORT-03
- Conditions
- Orthopedic Surgical Procedures, Postoperative Pain
- Keywords
- Lower Extremity, Sciatic Nerve, Anesthesia, Regional, Anesthetics, Local, Mepivacaine, Ultrasonography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Nov 2013 (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.
This study was designed to assess whether the injection of local anesthetic into the nerve (intraneural), as opposed to around it (perineural), leads to longer anesthesia and analgesia of the leg.
Some reports of accidental intraneural injection mention an extremely long duration. When different drugs and doses were evaluated in a clinical trial of intraneural injection, a longer-than-expected duration was reported.
The investigators will compare the two types of injection using the same drug, so as to determine if there is an actual difference in duration.
Detailed description
This randomized, controlled trial will investigate prospectively for differences in sensory and motor block duration after intra- or perineural injection of 1.5% (wt/vol) mepivacaine, a short-acting local anesthetic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineural | Active comparator | Procedure: Perineural Injection for Subgluteal Sciatic Nerve Block, Procedure: Femoral Nerve Block, Procedure: Patient-controlled postoperative analgesia, Drug: MepivacainePatients in this group will receive a perineural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia. |
| Intraneural | Experimental | Procedure: Intraneural Injection for Subgluteal Sciatic Nerve Block, Procedure: Femoral Nerve Block, Procedure: Patient-controlled postoperative analgesia, Drug: MepivacainePatients in this group will receive an intraneural injection of mepivacaine for subgluteal sciatic nerve block, in addition to a femoral nerve block and patient-controlled postoperative analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing non-emergent orthopedic procedure of knee, leg, foot with thigh tourniquet
- ASA Physical Status Class I-III
- Consenting to surgery under peripheral nerve block anesthesia (sciatic + femoral/saphenous block)
Key exclusion criteria (3 listed)
- Unable to understand or communicate for the purpose of the study
- Exhibiting signs of neuropathy in the ipsilateral extremity
- Inability to satisfactorily image the sciatic nerve in the opinion of the attending anesthesiologist
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 |
|---|---|---|
| Intraneural Injection for Subgluteal Sciatic Nerve BlockAlso: Injection beneath the common investing external layer, Subepineural Injection, Gluteal sciatic nerve block, Subparaneural injectionThe injection will start as the needle penetrates the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if nerve cross section expansion and a reduction in echogenicity are observed. Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach. | Procedure or surgery | Intraneural |
| Perineural Injection for Subgluteal Sciatic Nerve BlockAlso: Injection outside the common investing external layer, Epineural injection, Extraneural injectionThe injection will start as the needle indents the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as "intraneural" if the drug infiltrates the space between the epimysium of the surrounding muscles and the outer epineurium of the sciatic nerve. Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach. | Procedure or surgery | Perineural |
| Femoral Nerve BlockPatients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated. | Procedure or surgery | Intraneural, Perineural |
| Patient-controlled postoperative analgesiaAlso: PCA, PCIVA, PCCPNB, Patient-controlled continuous peripheral nerve blockPatients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication. | Procedure or surgery | Intraneural, Perineural |
| MepivacaineAlso: Local Anesthetic, CarbocaineThirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block. | Drug | Intraneural, Perineural |
Primary outcome
Differences in Time to Resolution of Sciatic Nerve Block
Time frame: <12 h
The time at which sensory and motor function of the sciatic nerve have recovered at least to the following criteria: * Sensory: patients feel discomfort when pricked with a thin needle (25G) * Motor: patients may move both toes and ankle, albeit with reduced strength This outcome measure will be examined by an investigator every 30-60 min and reported by patients as "time to return of sensation and movement". The investigator-reported value will be preferred if both are available.
3 secondary outcomes
Block Onset Time
Time frame: ≤30 min
Success Rate of Anesthetic Nerve Blocks
Time frame: ≤30 min
Incidence and Prevalence of Neurologic Disturbances
Time frame: 30 days
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 19 Nov 2013.
- Background: PubMed 20630694Benhamou D, Blonski E, Levy P, Plessis E, Chalhoub V. Ultra-long duration of a peripheral nerve block: a possible consequence of intraneural (subepineural) local anaesthetic injection. Ann Fr Anesth Reanim. 2010 Jul-Aug;29(7-8):589-91. doi: 10.1016/j.annfar.2010.05.032. Epub 2010 Jul 13.
- Background: PubMed 24108248Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf.
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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.
Marco Baciarello, MD principal investigator
University of Parma
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 Intraneural Injection for Subgluteal Sciatic Nerve Block, Perineural Injection for Subgluteal Sciatic Nerve Block and Femoral Nerve Block in people with Orthopedic Surgical Procedures and Postoperative Pain, run by University of Parma 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 3 inclusion and 3 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 19 Nov 2013. 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?
Differences in Time to Resolution of Sciatic Nerve Block (time frame: <12 h). 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 NCT01981291, which also lists 2 linked publications.
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 19 Nov 2013.