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

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Arthroplasty, Replacement, Knee
• Intervention / Treatment: Procedure: New local anesthesia injection site and new local anesthetic drug formulation.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weilong Diwu, M.M.; Phone Number: +8618792498312; Email: diwuweilong@sohu.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Department of Orthopedics, Xijing Hospital, The Air Force Medical University
      • Contact: Weilong Diwu, M.M.; Phone Number: +8618792498312; Email: diwuweilong@sohu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Traditional injection site and traditional local anesthetic formulation	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.
Experimental: Traditional injection site and new local anesthetic formulation	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.
Experimental: New injection site and traditional local anesthetic formulation	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.
Experimental: New injection site and new local anesthetic formulation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Diwuweilong

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): December 10, 2023

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: KY20212115-F-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No