Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty

Analgesia Clinical Trial

Official title:

Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202730
• Other study ID #: KY20212115-F-2
• Status: Recruiting
• Phase: N/A
• Start date: December 25, 2021
• Est. completion date: December 10, 2023

Study information

• Verified date: March 2023
• Source: Xijing Hospital
• Contact: Weilong Diwu, M.M.
• Phone: +8618792498312
• Email: diwuweilong[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Local anesthesia was performed on patients with total knee arthroplasty (TKA) through two different injection sites of local anesthetics and two local anesthetic drug . The pain score of patients after TKA was collected, then the analgesic effect of patients after TKA through two different injection sites and two different local anesthetic drug were analyzed and evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 10, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. Patients between the ages of 40-75, who meet the indications for total knee arthroplasty(TKA) surgery, plan to undergo unilateral TKA surgery, can tolerate surgical trauma, and have no surgical contraindications;

• 2. Patients who have good medical obedience and can cooperate to complete the evaluation of various indicators after the operation and continue to receive follow-up;

• 3. There is no contraindications to combined spinal-epidural anesthesia;

• 4. Agree to accept this trial and sign an informed consent form.

Exclusion Criteria:

• 1. Allergic to test drugs;

• 2. Abnormal liver, kidney or heart function;

• 3. People who have chronic pain symptoms in other parts of the body other than the knee joint;

• 4. Patients with a history of multiple operations on the knee joint, or patients with abnormal anatomical structures;

• 5. Patients who cannot perform early functional exercise after unconventional knee replacement or other systemic diseases;

• 6. Cannot communicate with researchers normally.

Related Conditions & MeSH terms

• Analgesia
• Arthroplasty, Replacement, Knee

Intervention

Procedure:
• New local anesthesia injection site and new local anesthetic drug formulation.
The traditional injection site is the posterior joint capsule and the popliteal artery space (iPACK) plus multiple layers of tissues around the knee joint (posterior joint capsule, ligaments and subcutaneous tissue). The traditional local anesthetic formulation is 1% ropivacaine 10ml+ normal saline 40ml+10mg Morphine + 5mg dexamethasone. The new local anesthesia injection site is iPACK+Knee Cutaneous Nerve Block. The new local anesthetic formula is 1% ropivacaine 10ml+ normal saline 40ml+10mg morphine+1ml triamcinolone acetonide.

Locations

Country	Name	City	State
China	Department of Orthopedics, Xijing Hospital, The Air Force Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Diwuweilong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the pain score before and after surgery	A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	pre-operation, 6hours after surgery, 24hours after surgery, 48 hours after surgery.