Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block
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ClinicalTrials.gov Identifier: NCT01555216 |
Recruitment Status
:
Withdrawn
(Lack of participant recruitment)
First Posted
: March 15, 2012
Last Update Posted
: May 27, 2016
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- No Results Posted
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hallux Valgus | Drug: Single injection posterior tibial nerve block Drug: Posterior tibial nerve catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Comparison of a Continuous Posterior Tibial Nerve Block and Single Injection Posterior Tibial Nerve Block in Patients Undergoing Forefoot Surgery |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Posterior tibial nerve catheter
5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours
Other Name: Naropin
|
Active Comparator: Single injection PTNB
Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine
|
Drug: Single injection posterior tibial nerve block
5 ml of 0.5% ropivacaine
Other Name: Naropin
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- Quality of recovery [ Time Frame: Up to five days ]Quality of recovery
- Pain control (pain score) [ Time Frame: Up to 1 week ]pain control (pain score) between groups
- Opioid consumption [ Time Frame: Up to 1 week ]Opioid consumption
- patient satisfaction [ Time Frame: Up to 1 week ]patient satisfaction with pain control

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555216
United States, Illinois | |
Northwestern Memorial Hospital | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Antoun Nader, MD | Northwestern Memorial Hospital |
Responsible Party: | Antoun Nader, Associate Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University |
ClinicalTrials.gov Identifier: | NCT01555216 History of Changes |
Other Study ID Numbers: |
STU00037311 |
First Posted: | March 15, 2012 Key Record Dates |
Last Update Posted: | May 27, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Antoun Nader, Northwestern University:
Forefoot surgery |
Additional relevant MeSH terms:
Hallux Valgus Foot Deformities Musculoskeletal Diseases Ropivacaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |