Regional Anesthesia MorbidityNCT02029404
Approach to Continuous Sciatic Nerve Block for Orthopedic Procedures in Day Surgery With Two Different Techniques
A study testing Tibial nerve group and Tibial peroneal nerve group in people with Regional Anesthesia Morbidity and Postoperative Pain, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial summary
We will enroll patients submitted to feet elective orthopaedic surgery that require analgesia through continuous peripheral nerve block (CNPB) of the sciatic nerve. All catheters will be placed by anaesthesiologists experienced in ultrasound in prone positioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia Morbidity, Postoperative Pain
- What is being tested?
- Tibial nerve group and Tibial peroneal nerve group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Apr 2015
- 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
- Patients candidates for orthopedic surgery of the lower limb in unilateral day-surgery with surgical incision in the distribution of the sciatic nerve
- Patients according to American Society of Anesthesiologists scale (ASA) I-II
- Age greater than 18 years
- Informed Consent
- Presence of a "caretaker" for the night and the next day.
Who cannot join
- Contraindications to regional anesthesia
- Patients ASA III-IV
- Patients receiving therapy for chronic pain
- Patients with: renal failure, coagulopathy, liver failure, peripheral neuropathy
- Refusal by the patient
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Day Surgery Ospedale di Circolo Varese
Varese, VA, 21100
About this study
We will enroll patients submitted to feet elective orthopaedic surgery that require analgesia through continuous peripheral nerve block (CNPB) of the sciatic nerve. All catheters will be placed by anaesthesiologists experienced in ultrasound in prone positioning. The patients will be randomized in two groups with technique of sealed envelopes.
In the tibial -peroneal nerve (TPN) group we will position the catheter within the confluence of peroneal and tibial nerve.
Read more
In the tibial nerve (TN) group we will proceed , previous local anaesthesia, to insert a catheter medially to tibial branch of the sciatic nerve according to in plane approach.
We will analyze A: the difference in consumption of local anesthetic in the two different groups B: the difference of "insensate limb" in the post-operative home as described by Ilfeld(inability to perceive the sense of touch throughout the area of distribution of the sciatic nerve) C: rate of foot drop D: numeric rate scale (NRS) for pain assessment, rate of dislodgment of the catheters, patient satisfaction, need for intervention by the anesthesiologist after discharge.
- Conditions
- Regional Anesthesia Morbidity, Postoperative Pain
- Being tested
- Tibial nerve group, Tibial peroneal nerve group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial nerve groupProcedure or surgery
After the recovery of the sensitivity we will start the continuous infusion of levobupivacaine 0,125% with a portable pump (Mini Rythmic Evolution, Micrel Medical Devices) with a flow basal rate 2 ml/h and a rescue bolus doses of 2 ml (lock out 20 minutes). Before the discharge from the hospital, if the NRS will be > 4, a bolus of 10 ml of Mepivacaine 1% through the catheter could be administered.
An "information sheet" will be released at the discharge and the medical indication for any "rescue doses" at home.
The patients will be contacted by phone at POD 1-2 and will allowed to answer to a questionnaire (see endpoint) At POD 3 the patients will come in our ambulatory where we will remove the catheter and they will return the pump
Tibial peroneal nerve groupProcedure or surgery
After the recovery of the sensitivity we will start the continuous infusion of levobupivacaine 0,125% with a portable pump (Mini Rythmic Evolution ,Micrel Medical Devices )with a flow basal rate 2 ml/h and a rescue bolus doses of 2 ml (lock out 20 minutes). Before the discharge from the hospital, if the NRS will be > 4, a bolus of 10 ml of Mepivacaine 1% through the catheter could be administered.
An "information sheet" will be released at the discharge and the medical indication for any "rescue doses" at home.
The patients will be contacted by phone at POD 1-2 and will allowed to answer to a questionnaire (see endpoint) At POD 3 the patients will come in our ambulatory where we will remove the catheter and they will return the pump
| Study group | Role | What they receive |
|---|---|---|
| Tibial nerve group | Active comparator | In the TN (tibial nerve ) group probe will be placed in popliteal cave to identify the popliteal artery and laterally the tibial nerve. Identified the tibial nerve we will proceed , previous local anaesthesia, to insert a catheter medially to tibial branch of the sciatic nerve according to in plane approach. Receives: Procedure: Tibial nerve group |
| Tibial peroneal nerve group | Active comparator | In the TPN (tibial -peroneal nerve) group the probe will be placed in popliteal cave to identify the popliteal artery and laterally the tibial nerve. Afterwards, proceeding cranially with the probe according to "in plane" approach, we will identify the confluence of tibial with peroneal branch and in this point, previous local anaesthesia, we will position the catheter within the confluence of peroneal and tibial nerve. Receives: Procedure: Tibial peroneal nerve group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the difference in consumption of local anesthetic in the two different groups
Measured: within the first two days after surgery
Secondary outcomes (1)
Analyze the difference of "insensate limb"in the post-operative home as described by Ilfeld (inability to perceive the sense of touch throughout the area of distribution of the sciatic nerve)
Measured: within the first two days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi
- Investigators
- Luca Guzzetti, MD, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029404
- Sponsor's protocol ID
- AAA-001
- Status last verified
- Oct 2014
- First submitted
- 6 Jan 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach to Continuous Sciatic Nerve Block for Orthopedic Procedures in Day Surgery With Two Different Techniques
- ClinicalTrials.gov ID
- NCT02029404
- Acronym / sponsor ID
- AAA-001
- Conditions
- Regional Anesthesia Morbidity, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Jan 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.
We will enroll patients submitted to feet elective orthopaedic surgery that require analgesia through continuous peripheral nerve block (CNPB) of the sciatic nerve. All catheters will be placed by anaesthesiologists experienced in ultrasound in prone positioning. The patients will be randomized in two groups with technique of sealed envelopes.
In the tibial -peroneal nerve (TPN) group we will position the catheter within the confluence of peroneal and tibial nerve.
In the tibial nerve (TN) group we will proceed , previous local anaesthesia, to insert a catheter medially to tibial branch of the sciatic nerve according to in plane approach.
We will analyze A: the difference in consumption of local anesthetic in the two different groups B: the difference of "insensate limb" in the post-operative home as described by Ilfeld(inability to perceive the sense of touch throughout the area of distribution of the sciatic nerve) C: rate of foot drop D: numeric rate scale (NRS) for pain assessment, rate of dislodgment of the catheters, patient satisfaction, need for intervention by the anesthesiologist after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibial nerve group | Active comparator | Procedure: Tibial nerve groupIn the TN (tibial nerve ) group probe will be placed in popliteal cave to identify the popliteal artery and laterally the tibial nerve. Identified the tibial nerve we will proceed , previous local anaesthesia, to insert a catheter medially to tibial branch of the sciatic nerve according to in plane approach. |
| Tibial peroneal nerve group | Active comparator | Procedure: Tibial peroneal nerve groupIn the TPN (tibial -peroneal nerve) group the probe will be placed in popliteal cave to identify the popliteal artery and laterally the tibial nerve. Afterwards, proceeding cranially with the probe according to "in plane" approach, we will identify the confluence of tibial with peroneal branch and in this point, previous local anaesthesia, we will position the catheter within the confluence of peroneal and tibial nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients candidates for orthopedic surgery of the lower limb in unilateral day-surgery with surgical incision in the distribution of the sciatic nerve
- Patients according to American Society of Anesthesiologists scale (ASA) I-II
- Age greater than 18 years
- Informed Consent
- Presence of a "caretaker" for the night and the next day.
Key exclusion criteria (5 listed)
- Contraindications to regional anesthesia
- Patients ASA III-IV
- Patients receiving therapy for chronic pain
- Patients with: renal failure, coagulopathy, liver failure, peripheral neuropathy
- Refusal by the patient
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 |
|---|---|---|
| Tibial nerve groupAfter the recovery of the sensitivity we will start the continuous infusion of levobupivacaine 0,125% with a portable pump (Mini Rythmic Evolution, Micrel Medical Devices) with a flow basal rate 2 ml/h and a rescue bolus doses of 2 ml (lock out 20 minutes). Before the discharge from the hospital, if the NRS will be > 4, a bolus of 10 ml of Mepivacaine 1% through the catheter could be administered. An "information sheet" will be released at the discharge and the medical indication for any "rescue doses" at home. The patients will be contacted by phone at POD 1-2 and will allowed to answer to a questionnaire (see endpoint) At POD 3 the patients will come in our ambulatory where we will remove the catheter and they will return the pump | Procedure or surgery | Tibial nerve group |
| Tibial peroneal nerve groupAfter the recovery of the sensitivity we will start the continuous infusion of levobupivacaine 0,125% with a portable pump (Mini Rythmic Evolution ,Micrel Medical Devices )with a flow basal rate 2 ml/h and a rescue bolus doses of 2 ml (lock out 20 minutes). Before the discharge from the hospital, if the NRS will be > 4, a bolus of 10 ml of Mepivacaine 1% through the catheter could be administered. An "information sheet" will be released at the discharge and the medical indication for any "rescue doses" at home. The patients will be contacted by phone at POD 1-2 and will allowed to answer to a questionnaire (see endpoint) At POD 3 the patients will come in our ambulatory where we will remove the catheter and they will return the pump | Procedure or surgery | Tibial peroneal nerve group |
Primary outcome
Compare the difference in consumption of local anesthetic in the two different groups
Time frame: within the first two days after surgery
1 secondary outcome
Analyze the difference of "insensate limb"in the post-operative home as described by Ilfeld (inability to perceive the sense of touch throughout the area of distribution of the sciatic nerve)
Time frame: within the first two days after surgery
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 8 Apr 2015.
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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.
Luca Guzzetti, MD principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial nerve group and Tibial peroneal nerve group in people with Regional Anesthesia Morbidity and Postoperative Pain, run by Ospedale di Circolo - Fondazione Macchi 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 5 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 8 Apr 2015. 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.
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?
Compare the difference in consumption of local anesthetic in the two different groups (time frame: within the first two days after surgery). 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 8 Apr 2015.