Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty
Primary Purpose
Arthroplasty, Replacement, Knee, Pain, Postoperative, Anesthesia and Analgesia
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound Guided Middle Adductor Canal Block
Ultrasound Guided Femoral Nerve Block.
Bupivacain
Spinal Anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Arthroplasty, Replacement, Knee focused on measuring femoral nerve block, adductor block, knee arthroplasty
Eligibility Criteria
Inclusion Criteria:
- ASA1-2-3 patients who will undergo unilateral elective primary total knee prosthesis surgery with consent for the study
- Patients whose operation has been successfully completed with spinal anesthesia
Exclusion Criteria:
- Refusal of the patient to work
- Patients under 18 years of age
- Patients who have undergone an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, sedoanelgesia, laryngeal mask application, etc.)
- Those with known local anesthetic allergies
- Body mass index> 35 patient groups
- Skin infection at the injection site
- Coagulopathy and use of anticoagulant therapy
- Uncontrolled diabetic patients
- Uncooperative patient
- Physiological and emotional lability
- Prolonged surgical intervention
- Patient with limitation of mobilization and movement before the operation, other than the operation reason
Sites / Locations
- İzmir Bozyaka Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1 Middle Adductor Canal Block
Group 2 Femoral Nerve Block.
Arm Description
Ultrasound Guided Middle Adductor Canal Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Ultrasound Guided Femoral Nerve Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Outcomes
Primary Outcome Measures
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Ambulation time
First time a patients can walk around independently
NRS at Ambulation
NRS when first time a patients can walk around independently
Secondary Outcome Measures
Time of First Rescue Opioid
When patient's pain score(NRS) is 3 or more.
Time of Return of Sensory Block
Examined with Prick Test
Time of Return of Motor Block
Examined with Examined with Holmenn Skalası
Full Information
NCT ID
NCT04768764
First Posted
February 22, 2021
Last Updated
February 22, 2021
Sponsor
Bozyaka Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04768764
Brief Title
Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty
Official Title
Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty In Terms Of Postoperative Pain Control And Early Mobilization
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2021 (Anticipated)
Primary Completion Date
October 16, 2021 (Anticipated)
Study Completion Date
April 16, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozyaka Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Femoral and adductor nerve blocks with ultrasonography(USG) guidance are used effectively and efficiently in post-operative pain management in lower extremity surgical procedures. However, the superiority of these two blocks to each other is still controversial. In this prospective, randomized, double-blind study, patients who underwent elective unilateral knee arthroplasty under spinal anesthesia, will be performed postoperative femoral block or middle adductor canal block with the guidance of USG.Patients who underwent spinal anesthesia and needed sedoanalgesia and who had to switch to general anesthesia will be excluded from the study. The patients will be divided into two groups by simple randomization. Since a total of 52 patients should be included in the study as a result of the power analysis (G-power 3.1); It is planned to take approximately 26 patients for each group.The anesthesiologist, who follows the pain control and mobilization after the block, will not know which study group the patient is in. The blocks will be performed behind the cover while the patient is under spinal anesthesia (Thus, the point of application of the block will not be noticed). In this way, the patient and the anesthesiologist who follows the parameters after the block will be blind to patient's arm. In the first group, 0.25% 20 ml of local anesthetic and middle adductor canal block, in the second group 0.25% 20 ml of local anesthetic and femoral nerve block will be applied We will compare these two blocks in terms of early mobilization, postoperative pain control, motor, and sensory block.
Detailed Description
All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll. Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group.Femoral block or middle adductor canal block will be applied to the patients.
Group1 (Group 1 Middle Adductor Canal Block) patients will be administered middle adductor canal block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.
Group2 (Femoral Nerve Block) patients will be administered femoral block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.
The selected block will be applied with USG behind the curtain after the operation.Patients will be taken to the postoperative recovery unit.Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Post-operatively, patients will receive 1mg/kg Tramadol when Numeric Rating Scale(NRS) > 3.The duration of the sensory and motor block and the mobilization of the patients will be recorded and compared.
0,2,4,6,8,12,24 of the patient pain scores at hour and 6 months, presence of sensory block and motor block, pain score when the patient is mobilized will be recorded.In addition, operation time, complications related to block, mobilization time, discharge day, and opioid need will be recorded.It will be recorded at what time the first opioid dose was administered after the block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Pain, Postoperative, Anesthesia and Analgesia, Anesthesia, Conduction, Nerve Block
Keywords
femoral nerve block, adductor block, knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
There are two groups: the first group is adductor block and the second group is femoral block.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Middle Adductor Canal Block
Arm Type
Active Comparator
Arm Description
Ultrasound Guided Middle Adductor Canal Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Arm Title
Group 2 Femoral Nerve Block.
Arm Type
Active Comparator
Arm Description
Ultrasound Guided Femoral Nerve Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Middle Adductor Canal Block
Other Intervention Name(s)
Regional Anesthesia
Intervention Description
Middle adductor canal block will be applied post-operatively with guidance of USG.
Drug:Bupivacaine 0.25% Injectable Solution
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Femoral Nerve Block.
Other Intervention Name(s)
Regional Anesthesia
Intervention Description
Femoral nerve block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
Marcain
Intervention Description
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution
Intervention Type
Procedure
Intervention Name(s)
Spinal Anesthesia
Intervention Description
Patients will be placed in the lateral decubitus position.Subarachnoid space will be entered through the most suitable intervertebral space.Bupivacaine 0.5% Heavy will be given in the appropriate dose.
Primary Outcome Measure Information:
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
At 0th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Time Frame
At 0th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
At 2nd hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Time Frame
At 2nd hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
At 4th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Time Frame
At 4th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
At 6th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Time Frame
At 6th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
At 8th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Time Frame
At 8th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
At 12th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Time Frame
At 12th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
At 24th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Time Frame
At 24th hour postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient according to NRS
Time Frame
At 6 months postoperatively
Title
Post-operative pain assessed by Numeric Rating Scale(NRS)
Description
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Time Frame
At 6 months postoperatively
Title
Ambulation time
Description
First time a patients can walk around independently
Time Frame
48 hours postoperatively
Title
NRS at Ambulation
Description
NRS when first time a patients can walk around independently
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Time of First Rescue Opioid
Description
When patient's pain score(NRS) is 3 or more.
Time Frame
48 hours postoperatively
Title
Time of Return of Sensory Block
Description
Examined with Prick Test
Time Frame
24 hours postoperatively
Title
Time of Return of Motor Block
Description
Examined with Examined with Holmenn Skalası
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA1-2-3 patients who will undergo unilateral elective primary total knee prosthesis surgery with consent for the study
Patients whose operation has been successfully completed with spinal anesthesia
Exclusion Criteria:
Refusal of the patient to work
Patients under 18 years of age
Patients who have undergone an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, sedoanelgesia, laryngeal mask application, etc.)
Those with known local anesthetic allergies
Body mass index> 35 patient groups
Skin infection at the injection site
Coagulopathy and use of anticoagulant therapy
Uncontrolled diabetic patients
Uncooperative patient
Physiological and emotional lability
Prolonged surgical intervention
Patient with limitation of mobilization and movement before the operation, other than the operation reason
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Göktaş
Phone
05062073485
Email
e.goktas44@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeki Tuncel Tekgül
Organizational Affiliation
İzmir Bozyaka Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
İzmir Bozyaka Training and Research Hospital
City
İzmir
ZIP/Postal Code
35170
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeki Tuncel Tekgül, Assoc. Prof.
Phone
05058554705
Email
zekittekgul@yahoo.com
First Name & Middle Initial & Last Name & Degree
Elif Göktaş, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty
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