CClinicalTrials.gg
WithdrawnNCT01555216Updated May 27, 2016

Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

An interventional study of Single injection posterior tibial nerve block and Posterior tibial nerve catheter in Hallux Valgus, sponsored by Northwestern University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-05-27.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Lack of participant recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hallux Valgus

Browse trials for

Keywords

  • Forefoot surgery
03

In context

Hallux Valgus

144 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.

Browse Hallux Valgus studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy).

Exclusion criteria

Exclusion Criteria:

  • 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
  • Chronic opioid or drug abuse
  • Diabetes
  • Active infection in leg
  • Unstable cardiovascular, renal or hepatic disease,
  • Unwillingness to comply with follow up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Posterior tibial nerve catheter

    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.

    Drug: Posterior tibial nerve catheter

  • Active comparator
    Single injection PTNB

    Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine

    Drug: Single injection posterior tibial nerve block

Interventions

  • DrugSingle injection posterior tibial nerve block

    5 ml of 0.5% ropivacaine

    Also known as: Naropin

  • DrugPosterior tibial nerve catheter

    5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours

    Also known as: Naropin

06

What researchers measure

Primary outcomes

  1. Quality of recovery

    Quality of recovery

    Time frame: Up to five days

Secondary outcomes

  1. Pain control (pain score)

    pain control (pain score) between groups

    Time frame: Up to 1 week

  2. Opioid consumption

    Opioid consumption

    Time frame: Up to 1 week

  3. patient satisfaction

    patient satisfaction with pain control

    Time frame: Up to 1 week

07

Study locations

1 site
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01555216
Lead sponsor
Northwestern University
Responsible party
Antoun Nader (Associate Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University) — Principal investigator
First posted
Mar 15, 2012
Start date
Oct 2011
Primary completion
Dec 2014
Completion
Dec 2014
Last update
May 27, 2016

Study contacts

Antoun Nader, MD
principal investigator · Northwestern Memorial Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion