- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06201195
Anterior Cutaneus Nerve and Distal Adductor Canal Block With USG for Total Knee Replacement Analgesia
Contribution of Anterior Femoral Cutaneous Nerve Block to Postoperative Analgesia for Total Knee Replacement
This prospective clinical study was approved by the institutional ethics committee on September 27, 2023, and patient enrollment started in October 2023. the study aimed to evaluate the contribution of anterior femoral cutaneus nerve block to postoperative analgesia in total knee artroplasty.
The goal of this clinical trial is to compare analhesia effects of adductor canal blockade versus distal adductur canal blockade added anterior cutaneus nerve block in total knee arthroplasty.
The main questions it aims to answer are:
- question 1: does distal adductor canal blockade + anterior cutaneus nerve blokade superior analgesia then adductor canal block for undergoing TKP?
- question 2: does distal adductor canal blockade + anterior cutaneus nerve blokade decrease drain place pain on anterolateral face of knee?
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Ankara Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Total knee artroplasty
- Spinal anesthesia
- ASA 1-3
Exclusion Criteria:
- Bupivacaine allergy
- Coagulopathy
- Infection on injection site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Adductor canal block
Usg guidance adductor canal block with %0.25 Bupivacaine 20 ml
|
VAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics
Other Names:
|
|
Active Comparator: Distal adductor canal block with anterior cutaneus nerve block
Usg guidance distal adductor canal block (%0.25 Bupivacaine 20 ml) with anterior cutaneus nerve block (%0.25 Bupivacaine 10 ml)
|
VAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS (visuel analouge scale)
Time Frame: postblock 3 hour,10 hour, 24 hour
|
for postoperative pain evaluation after TKA surgery.
The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end.
|
postblock 3 hour,10 hour, 24 hour
|
|
drain place pain
Time Frame: postblock 3 hour,10 hour, 24 hour
|
do you have any pain on drain place?
yes or no
|
postblock 3 hour,10 hour, 24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS movement
Time Frame: postblock 3 hour,10 hour, 24 hour
|
Postoperative pain with knee moves evaluate with VAS, The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end.
|
postblock 3 hour,10 hour, 24 hour
|
|
motor strenght
Time Frame: postblock 3 hour,10 hour, 24 hour
|
leg elevation and plantar flexion
|
postblock 3 hour,10 hour, 24 hour
|
Collaborators and Investigators
Investigators
- Study Director: Derya Ozkan, Study Principal Investigator Ankara Etlik City Hospital
- Principal Investigator: Müge Çakırca, doctor, Study Principal Investigator Ankara Etlik City Hospital
- Study Chair: Funda Atar, doctor, Study Principal Investigator Ankara Etlik City Hospital
- Study Chair: Serhan ünlü, doctor, Study Principal Investigator Ankara Etlik City Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK1-2023-556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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