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ESPB and ACB in Knee Arthroplasty

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Adductor Canal Block
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Erector Spinae Plane Block, Adductor Canal Block, Total Knee Arthroplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients who underwent total knee arthroplasty surgery ASA I-III patients Exclusion Criteria: Patients with coagulopathy Patients history with local anesthetic allergy or toxicity Patients with long hospital stay Patients with advanced organ failure Mental retarded patients Presence of infection at the injection site

Sites / Locations

  • Istanbul Medeniyet University Goztepe Suleyman Yalcın City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erector Spinae Plane Block

Adductor Canal Block

Arm Description

Erector Spina Plane Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.

Adductor Canal Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.

Outcomes

Primary Outcome Measures

Postoperative pain 30 minute
Visual anolog score (1-10)
Postoperative pain 1. hour
Visual anolog score (1-10)
Postoperative pain 2. hour
Visual anolog score (1-10)
Postoperative pain 6. hour
Visual anolog score (1-10)
Postoperative pain 12. hour
Visual anolog score (1-10)
Postoperative pain 24. hour
Visual anolog score (1-10)
Postoperative pain 36. hour
Visual anolog score (1-10)
Postoperative pain 48. hour
Visual anolog score (1-10)

Secondary Outcome Measures

Opioid consuption 30. min.
Petidine (mg)
Opioid consuption 1. hour
Petidine (mg)
Opioid consuption 2. hour
Petidine (mg)
Opioid consuption 6. hour
Petidine (mg)
Opioid consuption 12. hour
Petidine (mg)
Opioid consuption 24. hour
Petidine (mg)
Opioid consuption 36. hour
Petidine (mg)
Opioid consuption 48. hour
Petidine (mg)

Full Information

First Posted
October 6, 2022
Last Updated
November 10, 2022
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05613101
Brief Title
ESPB and ACB in Knee Arthroplasty
Official Title
Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Adductor Canal Block on Postoperative Pain, Opioid Consumption and Quadriceps Muscle Strength in Total Knee Arthroplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

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
Total knee arthroplasty surgery is preferred in the treatment of osteoarthritis and causes severe postoperative pain. In this study, we aimed to investigate the effects of lumbar erector spina plan block and adductor canal block on postoperative pain and quadriceps muscle strength in patients who underwent total knee arthroplasty with spinal anesthesia.
Detailed Description
In a prospective, randomized study; Medeniyet University Faculty of Medicine Göztepe Prof. Dr. Forty patients who underwent total knee arthroplasty surgery at Süleyman Yalçın City Hospital were divided into two groups. After the surgery was completed, erector spina plane block was applied to Group E (n=20) patients with 20 ml of 0.25% bupivacaine from the operated side L3-L4 level, while in Group A (n=20) patients, in the area where the sartorius muscle crosses the adductor magnus muscle, it was lateral to the superficial femoral artery. Adductor canal block was applied to the adductor canal with 20 ml of 0.5% bupivacaine. All patients were administered 1 gr paracetamol and 75 mg diclofenac sodium when their pain started in the orthopedic ward. Numerical pain score and quadriceps muscle strength were evaluated during the 48-hour follow-up of the patients. When the pain score was 4 and above, 50 mg pethidine hydrochloride was administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Erector Spinae Plane Block, Adductor Canal Block, Total Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Erector Plane Block Adductor Canal Block
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
Erector Spina Plane Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.
Arm Title
Adductor Canal Block
Arm Type
Active Comparator
Arm Description
Adductor Canal Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
After the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed parasagittally 2-3 cm lateral to the spinous process at the L3 or L4 level and the transverse process was visualized. The peripheral block needle (85 mm B Braun Stimuplex A) was advanced in plane up to the transverse process and 10 ml 0.5% bupivacaine hydrochloride 10 ml 0.9% isotonic NaCl mixture was applied on the erector spina muscle.
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Block
Intervention Description
After the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed in the middle between the medial condyle and the SIAS, and the superficial femoral artery (FSA) was visualized under the sartorius muscle. By following the FSA distally, the point where the sartorius muscle crosses the adductor magnus muscle, which is the beginning of the adductor canal, was found and the saphenous nerve was visualized hyperechoic in the anterolateral aspect of the FSA. 20 cc 0.5% bupivacaine hydrochloride was applied
Primary Outcome Measure Information:
Title
Postoperative pain 30 minute
Description
Visual anolog score (1-10)
Time Frame
30. min.
Title
Postoperative pain 1. hour
Description
Visual anolog score (1-10)
Time Frame
1. hour
Title
Postoperative pain 2. hour
Description
Visual anolog score (1-10)
Time Frame
2. hour
Title
Postoperative pain 6. hour
Description
Visual anolog score (1-10)
Time Frame
6. hour
Title
Postoperative pain 12. hour
Description
Visual anolog score (1-10)
Time Frame
12. hour
Title
Postoperative pain 24. hour
Description
Visual anolog score (1-10)
Time Frame
24. hour
Title
Postoperative pain 36. hour
Description
Visual anolog score (1-10)
Time Frame
36. hour
Title
Postoperative pain 48. hour
Description
Visual anolog score (1-10)
Time Frame
48. hour
Secondary Outcome Measure Information:
Title
Opioid consuption 30. min.
Description
Petidine (mg)
Time Frame
30. min.
Title
Opioid consuption 1. hour
Description
Petidine (mg)
Time Frame
1. hour
Title
Opioid consuption 2. hour
Description
Petidine (mg)
Time Frame
2. hour
Title
Opioid consuption 6. hour
Description
Petidine (mg)
Time Frame
6. hour
Title
Opioid consuption 12. hour
Description
Petidine (mg)
Time Frame
12. hour
Title
Opioid consuption 24. hour
Description
Petidine (mg)
Time Frame
24. hour
Title
Opioid consuption 36. hour
Description
Petidine (mg)
Time Frame
36. hour
Title
Opioid consuption 48. hour
Description
Petidine (mg)
Time Frame
48. hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who underwent total knee arthroplasty surgery ASA I-III patients Exclusion Criteria: Patients with coagulopathy Patients history with local anesthetic allergy or toxicity Patients with long hospital stay Patients with advanced organ failure Mental retarded patients Presence of infection at the injection site
Facility Information:
Facility Name
Istanbul Medeniyet University Goztepe Suleyman Yalcın City Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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ESPB and ACB in Knee Arthroplasty

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