- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05613101
ESPB and ACB in Knee Arthroplasty
November 10, 2022 updated by: İnal Bensu Arıoglu, Istanbul Medeniyet University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Istanbul Medeniyet University Goztepe Suleyman Yalcın City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Erector Spinae Plane Block
Erector Spina Plane Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.
|
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.
|
|
Active Comparator: Adductor Canal Block
Adductor Canal Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain 30 minute
Time Frame: 30. min.
|
Visual anolog score (1-10)
|
30. min.
|
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Postoperative pain 1. hour
Time Frame: 1. hour
|
Visual anolog score (1-10)
|
1. hour
|
|
Postoperative pain 2. hour
Time Frame: 2. hour
|
Visual anolog score (1-10)
|
2. hour
|
|
Postoperative pain 6. hour
Time Frame: 6. hour
|
Visual anolog score (1-10)
|
6. hour
|
|
Postoperative pain 12. hour
Time Frame: 12. hour
|
Visual anolog score (1-10)
|
12. hour
|
|
Postoperative pain 24. hour
Time Frame: 24. hour
|
Visual anolog score (1-10)
|
24. hour
|
|
Postoperative pain 36. hour
Time Frame: 36. hour
|
Visual anolog score (1-10)
|
36. hour
|
|
Postoperative pain 48. hour
Time Frame: 48. hour
|
Visual anolog score (1-10)
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48. hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consuption 30. min.
Time Frame: 30. min.
|
Petidine (mg)
|
30. min.
|
|
Opioid consuption 1. hour
Time Frame: 1. hour
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Petidine (mg)
|
1. hour
|
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Opioid consuption 2. hour
Time Frame: 2. hour
|
Petidine (mg)
|
2. hour
|
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Opioid consuption 6. hour
Time Frame: 6. hour
|
Petidine (mg)
|
6. hour
|
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Opioid consuption 12. hour
Time Frame: 12. hour
|
Petidine (mg)
|
12. hour
|
|
Opioid consuption 24. hour
Time Frame: 24. hour
|
Petidine (mg)
|
24. hour
|
|
Opioid consuption 36. hour
Time Frame: 36. hour
|
Petidine (mg)
|
36. hour
|
|
Opioid consuption 48. hour
Time Frame: 48. hour
|
Petidine (mg)
|
48. hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2021
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
August 30, 2022
Study Registration Dates
First Submitted
October 6, 2022
First Submitted That Met QC Criteria
November 10, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
November 14, 2022
Last Update Submitted That Met QC Criteria
November 10, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMUG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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