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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03188809
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 5, 2017
Est. completion date December 31, 2017

Study information

Verified date March 2024
Source Kecioren Education and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses. investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee replasment under spinal anesthesia in this study.


Description:

After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses. investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee revision under spinal anesthesia in this study. Materials and Methods: The patient will be informed about the procedure to be performed before the operation and written approval will be given. The patient will be premeditated with 2mg midazolam and sedayon and monitored according to routine operating room procedures and total knee prosthesis operation under spinal anesthesia. Patients will then be transferred to the collection room and ECG, NIBP and SpO2 monitoring and appropriate sterilization will be performed, and a grubby femoral nerve catheter with USG will be attached to the other group adductor channel catheter. A 20cc 0.25% marcain will be administered in 6 hours, with the first dose catheter placed in both groups. In the compilation unit, the patient will be infused with IV PCA in the morphine. The bolus dose of 1 mg IV of the PC will be adjusted to the duration of 10 minutes of lockout. Postoperatively, 3x1 metoclopramide, 4x1 gr / 24h IV paracetamol and 3x50 mg / 24h IV dexketoprofen will be administered to each patient. In this process, demographic information of the patients, peroperative KH, ABP, SpO2 values will be recorded. In the postoperative period, the patient's pain level, opioid requirement, motor block and muscle strength will be recorded and compared statistically.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 31, 2017
Est. primary completion date December 30, 2017
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria: - ASA1-2-3 patients - older than 55 years - who undergo elective total knee prosthesis in our hospital Exclusion Criteria: - ASA IV patients , - patients with local anesthesia that we use, - patients with coagulation disorders, - patients with anatomical anomalies, - patients with localized infection in the injection site , - patients who is incapable of using pca and/ or evaulate VAS scale, - patients with peripheral nerve disease, - patients with different surgical planning, - complicated gonarthrosis patients, - revision planned patients, - patients who refuse to be involved in the study

Study Design


Intervention

Procedure:
Adductor Canal Block
Adductor channel is roughly triangular in cross section and is bounded by three muscles: quadriceps anterolaterally (specifically vastusmedialis), sartorius medially and adductor magnus posteriorly. Within this canal is the femoral artery, femoral vein, the posterior branch of the obturator nerve, and branches of the femoral nerve; specifically the saphenous nerve and nerve to vastus medialis. When the femoral artery is shown by ultrasonography 21 gauge, 50 mm needle in-plane technique and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
femoral nerve block
The probe is placed just below the inguinal crease , when the femoral artery is shown by ultrasonography, the femoral nerve stays in the lateral direction and 21 gauge, 50 mm needle will be advanced from the anterior to the posteriomedial with an in-plane technique and the catheter will be inserted by the peripheral nerve stimulator in the lateral femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.

Locations

Country Name City State
Turkey SEDA Ankara Kecioren

Sponsors (1)

Lead Sponsor Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Muscle strength- Quadriceps Muscle strength scale Quadriceps Muscle strength scale postoperative 48 hour
Secondary postoperative analgesia - Visual analog scale Visual analog scale 72 hour
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