Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT01555216
First received: October 20, 2011
Last updated: September 23, 2014
Last verified: September 2014
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Purpose
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 | Intervention |
|---|---|
|
Hallux Valgus |
Drug: Ropivacaine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Quality of recovery [ Time Frame: Up to five days ] [ Designated as safety issue: No ]Quality of recovery
Secondary Outcome Measures:
- Pain control (pain score) [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]pain control (pain score) between groups
- Opioid consumption [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]Opioid consumption
- patient satisfaction [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]patient satisfaction with pain control
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Posterior tibial nerve catheter
Posterior tibial nerve catheter connected to a portable pump
|
Drug: Ropivacaine
3 ml/h of 0.2% ropivacaine with a bolus every two hours
|
|
Active Comparator: Single injection posterior tibial nerve block
Single injection posterior tibial nerve block of 0.5% ropivacaine
|
Drug: Ropivacaine
5 ml of 0.5% ropivacaine
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555216
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555216
Contacts
| Contact: Mark Kendall, MD | 312-926-5278 | m-kendall@northwestern.edu |
Locations
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Mark Kendall, M.D. 312-926-5278 m-kendall@northwester.edu | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Antoun Nader, MD | Northwestern Memorial Hospital |
More Information
No publications provided
| 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 |
| Study First Received: | October 20, 2011 |
| Last Updated: | September 23, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Forefoot surgery |
Additional relevant MeSH terms:
|
Ropivacaine Anesthetics Anesthetics, Local Central Nervous System Agents Central Nervous System Depressants |
Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015