Nerve Block Clinical Trial
Official title:
Catheter Over Needle Technique Causes Less Leakage and Secondary Failure Than Catheter Through Needle Technique for Continuous Femoral Nerve Block
Verified date | April 2016 |
Source | Sir Charles Gairdner Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
To randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference.
Status | Completed |
Enrollment | 110 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients presenting to Sir Charles Gairdner Hospital for elective, unilateral, primary total knee replacement. - Body mass index 18-40 kg/m2 - American Society of Anaesthetists (ASA) grade I-III Exclusion Criteria: - Allergy to local anaesthetic - Inability to cooperate - Inability to read, speak and understand English - Less than 18 years old |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Lead Sponsor | Collaborator |
---|---|
Sir Charles Gairdner Hospital |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Catheter leakage | Any leakage around the catheter insertion site as assessed by visual inspection. | 2 days post insertion | No |
Secondary | Overall rate of secondary failure as assessed by the acute pain service on days 1 and 2 post op. | Secondary failure is when a nerve catheter that was previously working has ceased to provide analgesia. | 2 days | No |
Secondary | Ease of insertion assessed by the inserting anaesthetist on a 5 point Likert scale. | Assess the anaesthetist's opinion on the ease of insertion of the different catheters | intraoperative | No |
Secondary | Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale. | Assessing the needle visibility in the two different catheter systems. | intraoperative | No |
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