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

NCT05202730 | Unknown

• 1 other identifier: KY20212115-F-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Traditional injection site and traditional local anesthetic formulation

OTHER

Procedure: New local anesthesia injection site and new local anesthetic drug formulation.

Traditional injection site and new local anesthetic formulation

EXPERIMENTAL

Procedure: New local anesthesia injection site and new local anesthetic drug formulation.

New injection site and traditional local anesthetic formulation

EXPERIMENTAL

Procedure: New local anesthesia injection site and new local anesthetic drug formulation.

New injection site and new local anesthetic formulation

EXPERIMENTAL

Procedure: New local anesthesia injection site and new local anesthetic drug formulation.

Interventions

New local anesthesia injection site and new local anesthetic drug formulation. PROCEDURE

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.

New injection site and new local anesthetic formulation; New injection site and traditional local anesthetic formulation; Traditional injection site and new local anesthetic formulation; Traditional injection site and traditional local anesthetic formulation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;
• \. 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;
• \. There is no contraindications to combined spinal-epidural anesthesia;
• \. Agree to accept this trial and sign an informed consent form.

You may not qualify if:

• \. Allergic to test drugs;
• \. Abnormal liver, kidney or heart function;
• \. People who have chronic pain symptoms in other parts of the body other than the knee joint;
• \. Patients with a history of multiple operations on the knee joint, or patients with abnormal anatomical structures;
• \. Patients who cannot perform early functional exercise after unconventional knee replacement or other systemic diseases;
• \. Cannot communicate with researchers normally.

Sponsors & Collaborators

• Diwuweilong: lead

Study Sites (1)

Department of Orthopedics, Xijing Hospital, The Air Force Medical University

Xi’an, Shanxi, 710032, China

RECRUITING

Related Publications (1)

• Diwu W, Tang W, Yan M, Ma W, Xu H, Sun Q, Han Y, Wang Y, Wang C, Zhang D, Bi L, Yang M. Efficacy of Peripheral Cutaneous Nerve (PCN) on postoperative pain and functional outcome after total knee arthroplasty: a single-blind, randomized controlled clinical trial". BMC Anesthesiol. 2025 Jul 1;25(1):322. doi: 10.1186/s12871-025-03182-z.

  PMID: 40597686 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Weilong Diwu, M.M.

CONTACT

+8618792498312; diwuweilong@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 21, 2022
• Study Start: December 25, 2021
• Primary Completion: July 31, 2023
• Study Completion: December 10, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

CN (1)