Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2010-02-28
2011-04-30
Brief Summary
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In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tibial
Catheter
Catheter inserted into either perineural tibial nerve or wound
Wound
Catheter
Catheter inserted into either perineural tibial nerve or wound
Sham
Catheter
Catheter inserted into either perineural tibial nerve or wound
Interventions
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Catheter
Catheter inserted into either perineural tibial nerve or wound
Eligibility Criteria
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Inclusion Criteria
* Able to give written consent
* Patients having elective forefoot surgery with a planned ankle block.
* Expected postoperative pain to be at least moderate in severity the day following surgery
Exclusion Criteria
* Inability to communicate
* History of alcohol or opioid abuse (also chronic opioid user)
* Mental or medical conditions which may affect quantifying pain scores (VAS)
18 Years
80 Years
ALL
Yes
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Queens' Medical Centre
Locations
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Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Other Identifiers
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QMC-1975-NB
Identifier Type: OTHER
Identifier Source: secondary_id
QMC-1975-HJ
Identifier Type: -
Identifier Source: org_study_id