Investigation of the Effect of Proximal and Distal Adductor Canal Block in Knee Replacement Surgery

Knee Osteoarthritis Clinical Trial

Official title:

Investigation of the Effect of Proximal and Distal Adductor Canal Block on Pain Control and Functional Mobility in Total Knee Prosthesis Surgery Performed Under Spinal Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188806
• Other study ID #: URH-AR-ZT-06
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: August 10, 2024

Study information

• Verified date: May 2024
• Source: Umraniye Education and Research Hospital
• Contact: Zeliha TUNCEL
• Phone: +90 505 357 74 83
• Email: zelihalara[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to investigate the effect of adductor canal block applied with two different approaches in the treatment of pain after TKA surgery on pain control and functional mobility.

Description:

This prospective randomized trial is randomly divided into 3 groups using the method. Total knee arthroplasty is performed by the same surgical team. is applied. The patients were divided into proximal ACB applied, distal ACB applied and control groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: August 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Medications for unilateral TKA surgery
• Patients aged 18-85
• ASA 1-3

Exclusion Criteria:

• Patients under 18 years of age and over 85 years of age
• Patients with ASA 4 and above
• Patients with cognitive impairment
• Patients with application site infection
• Patients allergic to local anesthesia
• Patients receiving anticoagulant therapy
• Patients with bleeding diathesis
• Patients with chronic opioid or substance use
• Patients with insulin-dependent diabetes mellitus
• patients with neuropathy
• patients with hepatic or renal failure
• Patients who do not accept the procedure to be applied

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• ADDUKTOR CANAL BLOCK
All patients who will undergo adductor canal block are sedated with midazolam 0.03 mg/kg in the preoperative preparation room, after standard monitoring. After 2-3 ml skin infiltration with 2% lidocaine under sterile conditions, a block is applied under USG guidance.To verify block success, sensory function is assessed by pinprick testing along the saphenous nerve distribution by comparing the pinprick sensation to the unaffected limb.All patients are monitored in the operating room and in a sitting position, 10-20 mg (2-4 ml) of heavy marcaine (0.5% bupivacaine hydrochloride and dextrose monohydrate) is applied to the subarachnoid space by entering the L3-4 or L4-5 space with a 25-gauge Whitrace needle.For postoperative multimodal analgesia, which is routinely applied to all patients, intravenous PCA (patient controlled analgesia )tramadol and paracetamol 10 mg / kg iv (8 hours apart) will be given.
• CONTROL GROUP
No nerve block procedure is applied to patients.All patients are monitored in the operating room and in a sitting position, 10-20 mg (2-4 ml) of heavy marcaine (0.5% bupivacaine hydrochloride and dextrose monohydrate) is applied to the subarachnoid space by entering the L3-4 or L4-5 space with a 25-gauge Whitrace needle.For postoperative multimodal analgesia, which is routinely applied to all patients, intravenous PCA (patient controlled analgesia) tramadol 50 mg at 10 mg / hour basal rate after loading (20 mg bolus dose + 30 minutes lock time) and paracetamol 10 mg / kg iv (8 hours apart) will be given.

Locations

Country	Name	City	State
Turkey	Umraniye Education and Research Hospital	Istanbul	Umraniye

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VISUAL ANALOGUE SCALE(VAS)	VAS pain score was evaluated as "no pain" (score=0) and "worst pain" (score=10) and was divided into 3 groups according to the World Health Organization's pain intensity scale: score <3 mild pain, 3-6 mild-moderate. degree pain and >6 moderate-severe pain.	POSTOPERATIVE 6, 12 AND 24 HOURS
Secondary	first mobilization time	The first postoperative mobilization hours of the patients will be recorded.	within postoperative 24 hours
Secondary	length of hospital stay	The time between patients' admission and discharge will be recorded.	ONE WEEK
Secondary	opioid use	Intravenous PCA will be applied to each patient and the total tramadol dose spent will be calculated.intravenous PCA (patient controlled analgesia) tramadol 50 mg at 10 mg / hour basal rate after loading (20 mg bolus dose + 30 minutes lock time)	within postoperative 24 hours