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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05613101
Other study ID # IstanbulMUG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2021
Est. completion date August 30, 2022

Study information

Verified date November 2022
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 30, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Erector Spinae Plane Block
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.
Adductor Canal Block
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

Locations

Country Name City State
Turkey Istanbul Medeniyet University Goztepe Suleyman Yalcin City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain 30 minute Visual anolog score (1-10) 30. min.
Primary Postoperative pain 1. hour Visual anolog score (1-10) 1. hour
Primary Postoperative pain 2. hour Visual anolog score (1-10) 2. hour
Primary Postoperative pain 6. hour Visual anolog score (1-10) 6. hour
Primary Postoperative pain 12. hour Visual anolog score (1-10) 12. hour
Primary Postoperative pain 24. hour Visual anolog score (1-10) 24. hour
Primary Postoperative pain 36. hour Visual anolog score (1-10) 36. hour
Primary Postoperative pain 48. hour Visual anolog score (1-10) 48. hour
Secondary Opioid consuption 30. min. Petidine (mg) 30. min.
Secondary Opioid consuption 1. hour Petidine (mg) 1. hour
Secondary Opioid consuption 2. hour Petidine (mg) 2. hour
Secondary Opioid consuption 6. hour Petidine (mg) 6. hour
Secondary Opioid consuption 12. hour Petidine (mg) 12. hour
Secondary Opioid consuption 24. hour Petidine (mg) 24. hour
Secondary Opioid consuption 36. hour Petidine (mg) 36. hour
Secondary Opioid consuption 48. hour Petidine (mg) 48. hour
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