Hallux ValgusNCT01555216
Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block
A study testing Single injection posterior tibial nerve block and Posterior tibial nerve catheter in people with Hallux Valgus, run by Northwestern University at 1 site in United States.
Trial summary
Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of postoperative pain control included oral narcotics, single injection regional techniques and more recently continuous nerve catheters. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Single injection posterior tibial nerve block and Posterior tibial nerve catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy).
Who cannot join
- Patient refusal to be included
- Presence of language barrier that prohibits proper communication with patient
- Under age of 18,
- Pregnancy
- History of allergy to local anesthetics or opioids
- Presence of a progressive neurological deficit
Show all 11Show fewer
- Chronic opioid or drug abuse
- Diabetes
- Active infection in leg
- Unstable cardiovascular, renal or hepatic disease,
- Unwillingness to comply with follow up.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Randomized Comparison of a Continuous Posterior Tibial Nerve Block and Single Injection Posterior Tibial Nerve Block in Patients Undergoing Forefoot Surgery
Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of postoperative pain control included oral narcotics, single injection regional techniques and more recently continuous nerve catheters. Recent studies have demonstrated a benefit with continuous popliteal catheters when compared to single injection techniques in regards to postoperative pain control and patient satisfaction for foot surgeries.
Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and does not involve the peroneal nerve. The purpose of this study is to compare the continuous posterior tibial nerve catheter with a single injection posterior tibial nerve block when used as part of a surgical ankle block for forefoot surgery.
- Conditions
- Hallux Valgus
- Being tested
- Single injection posterior tibial nerve block, Posterior tibial nerve catheter
- Keywords
- Forefoot surgery
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single injection posterior tibial nerve blockDrug
Also called Naropin
5 ml of 0.5% ropivacaine
Posterior tibial nerve catheterDrug
Also called Naropin
5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours
| Study group | Role | What they receive |
|---|---|---|
| Posterior tibial nerve catheter | Active comparator | 5 ml bolus of 0.5% ropivacaine. The catheter will then be connected to a portable pump delivering 3 ml/h of 0.2% ropivacaine with a 2ml bolus every two hours. Receives: Drug: Posterior tibial nerve catheter |
| Single injection PTNB | Active comparator | Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine Receives: Drug: Single injection posterior tibial nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
Quality of recovery
Measured: Up to five days
Secondary outcomes (3)
Pain control (pain score)
pain control (pain score) between groups
Measured: Up to 1 week
Opioid consumption
Opioid consumption
Measured: Up to 1 week
patient satisfaction
patient satisfaction with pain control
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Lack of participant recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoun Nader, Northwestern University
- Investigators
- Antoun Nader, MD, Principal investigator, Northwestern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555216
- Sponsor's protocol ID
- STU00037311
- Status last verified
- May 2016
- First submitted
- 20 Oct 2011
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of a Continuous Posterior Tibial Nerve Block and Single Injection Posterior Tibial Nerve Block in Patients Undergoing Forefoot Surgery
- ClinicalTrials.gov ID
- NCT01555216
- Acronym / sponsor ID
- STU00037311
- Conditions
- Hallux Valgus
- Keywords
- Forefoot surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of participant recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Mar 2012 (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.
Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of postoperative pain control included oral narcotics, single injection regional techniques and more recently continuous nerve catheters. Recent studies have demonstrated a benefit with continuous popliteal catheters when compared to single injection techniques in regards to postoperative pain control and patient satisfaction for foot surgeries.
Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and does not involve the peroneal nerve. The purpose of this study is to compare the continuous posterior tibial nerve catheter with a single injection posterior tibial nerve block when used as part of a surgical ankle block for forefoot surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior tibial nerve catheter | Active comparator | Drug: Posterior tibial nerve catheter5 ml bolus of 0.5% ropivacaine. The catheter will then be connected to a portable pump delivering 3 ml/h of 0.2% ropivacaine with a 2ml bolus every two hours. |
| Single injection PTNB | Active comparator | Drug: Single injection posterior tibial nerve blockSingle injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy).
Key exclusion criteria (11 listed)
- Patient refusal to be included
- Presence of language barrier that prohibits proper communication with patient
- Under age of 18,
- Pregnancy
- History of allergy to local anesthetics or opioids
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 |
|---|---|---|
| Single injection posterior tibial nerve blockAlso: Naropin5 ml of 0.5% ropivacaine | Drug | Single injection PTNB |
| Posterior tibial nerve catheterAlso: Naropin5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours | Drug | Posterior tibial nerve catheter |
Primary outcome
Quality of recovery
Time frame: Up to five days
Quality of recovery
3 secondary outcomes
Pain control (pain score)
Time frame: Up to 1 week
Opioid consumption
Time frame: Up to 1 week
patient satisfaction
Time frame: Up to 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Individual participant dataSharing planned: No
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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.
Antoun Nader, MD principal investigator
Northwestern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single injection posterior tibial nerve block and Posterior tibial nerve catheter in people with Hallux Valgus, run by Northwestern University at 1 site in United States.
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 11 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: withdrawn, as of the sponsor's last update on 27 May 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Quality of recovery (time frame: Up to five days). 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 27 May 2016.