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Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses Arthroplasty

Primary Purpose

Postoperative Pain, Functional Outcomes

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Adductor Canal Block
femoral nerve block
Sponsored by
Kecioren Education and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Pain, Functional Outcomes, Total Knee Arthroplasty, Adductor Canal Block, Femoral Nerve Block

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SEDARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

femoral nerve block

adductor canal block

Arm Description

Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.

Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.

Outcomes

Primary Outcome Measures

Postoperative Muscle strength- Quadriceps Muscle strength scale
Quadriceps Muscle strength scale

Secondary Outcome Measures

postoperative analgesia - Visual analog scale
Visual analog scale

Full Information

First Posted
April 4, 2017
Last Updated
November 3, 2017
Sponsor
Kecioren Education and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03188809
Brief Title
Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses Arthroplasty
Official Title
Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses: Postoperative Analgesia and Functional Outcomes After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kecioren Education and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Functional Outcomes
Keywords
Postoperative Pain, Functional Outcomes, Total Knee Arthroplasty, Adductor Canal Block, Femoral Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind, randomised, controlled train
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
femoral nerve block
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
Arm Title
adductor canal block
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Block
Other Intervention Name(s)
saphen nerve block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
femoral nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Muscle strength- Quadriceps Muscle strength scale
Description
Quadriceps Muscle strength scale
Time Frame
postoperative 48 hour
Secondary Outcome Measure Information:
Title
postoperative analgesia - Visual analog scale
Description
Visual analog scale
Time Frame
72 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SEDA ILHAN
Phone
+905388342776
Email
kurtbeyogluseda@gmail.com
Facility Information:
Facility Name
SEDA
City
Ankara
State/Province
Kecioren
ZIP/Postal Code
06380
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SEDA ILHAN
Phone
+905388342776
Email
kurtbeyogluseda@gmail.com
First Name & Middle Initial & Last Name & Degree
SEDA ILHAN

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses Arthroplasty

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