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

Not Applicable

Recruiting

• Conditions: Arthroplasty, Replacement, Knee; Analgesia
• Interventions: Procedure: New local anesthesia injection site and new local anesthetic drug formulation.

• Registration Number: NCT05202730
• Lead Sponsor: Diwuweilong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-05
• Study Start: 2021-12-25
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
New injection site and new local anesthetic formulation	New local anesthesia injection site and new local anesthetic drug formulation.	-
Traditional injection site and traditional local anesthetic formulation	New local anesthesia injection site and new local anesthetic drug formulation.	-
Traditional injection site and new local anesthetic formulation	New local anesthesia injection site and new local anesthetic drug formulation.	-
New injection site and traditional local anesthetic formulation	New local anesthesia injection site and new local anesthetic drug formulation.	-

Primary Outcome Measures

Name	Time	Method
Change of the pain score before and after surgery	pre-operation, 6hours after surgery, 24hours after surgery, 48 hours 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.

Trial Locations

Locations (1)

Department of Orthopedics, Xijing Hospital, The Air Force Medical University; 🇨🇳 Xi'an, Shanxi, China